NeoplasmsEarly Phase 1NCT03433898
This Study Aims to Find a Safe and Effective Dose of BI 754091. The Study Also Aims to Find Safe and Effective Doses of BI 754091 and BI 754111 in Combination. This Study is Done in Asian Patients With Different Types of Cancer
A Early Phase 1 study testing Ezabenlimab and BI 754111 in people with Neoplasms, run by Boehringer Ingelheim at 13 sites in 3 countries.
Trial summary
The main objectives of the BI 754091 monotherapy dose-finding part (Part I) of the trial are to investigate the following items in advanced solid tumours: Safety, tolerability, and pharmacokinetics (PK) of BI 754091 as monotherapy. Maximum tolerated dose (MTD) and/or recommended dose (RD) of BI 754091 monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Ezabenlimab and BI 754111
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 23 Feb 2018to 20 Jul 2023
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Of full age (according to local legislation) at the time of signing of the informed consent form (ICF)
- Women of childbearing potential (WOCBP)1 with negative serum pregnancy test at screening and men able to father a child, who agree to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. The requirement of contraception does not apply to women of no childbearing potential but they must have an evidence of such at screening
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Patients with measurable lesions according to RECIST v1.1
- Conditions specific to respective part of the trial:
- Part I (BI 754091 dose-finding part):
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- Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type)
- For whom no therapy of proven efficacy exists, or who are not amenable to standard therapies.
- Previous treatment with an anti-PD-1 mAb is allowed as long as the last administration of the anti PD-1 mAb on the previous treatment is a minimum of 28 days prior to the first BI 754091 treatment.
- Part II (Combination dose-finding part):
- Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type)
- For whom no therapy of proven efficacy exists, or who are not amenable to standard therapies.
- Previous treatment with an anti-PD-1 mAb is allowed as long as the last administration of the anti PD-1 mAb on the previous treatment is a minimum of 28 days prior to the first BI 754091 treatment.
- Part III (Expansion part):
- Cohort A: Patients with gastric/esophagogastric junction cancer, with no prior treatment with anti-PD-1/PD-L1 antibody, and who received at least one line of systemic medical treatment excluding adjuvant therapy
- Cohort B: Patients with esophageal cancer with no prior treatment with anti-PD-1/PD-L1 antibody, and who received at least one line of systemic medical treatment excluding adjuvant therapy
- Cohort C: Patients with hepatocellular cancer with no prior treatment with anti-PD-1/PD-L1 antibody, who received at least one line of systemic medical treatment excluding adjuvant therapy, and whose Child-Pugh score is 7 or less
- Cohort D: Patients with gastric/esophagogastric junction cancer, esophageal cancer, or hepatocellular cancer with a prior treatment with anti-PD-1/PD-L1 antibody
- Cohort E: First line squamous or non-squamous NSCLC patients:
- Without EGFR mutations or ALK rearrangements
- PD-L1 expression level <50%
- All cohorts: Patients with advanced and/or metastatic disease, with at least 1 tumour lesion amenable to biopsy, and must be medically fit for biopsy at screening as determined by investigator and willing to undergo a biopsy before first treatment (if adequate archival tissue is not available) and, unless clinically contraindicated, after 6 weeks on therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0 to 1 at screening
Who cannot join
- Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to study entry or planned within 12 months after screening, e.g. hip replacement
- Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
- Previous treatment with study medications in this trial
- Any investigational or anti-tumour treatment within 4 weeks or 5 half-life periods (whichever is shorter) prior to the initiation of trial treatment
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 neuropathy due to prior platinum-based therapy
- (Part II and III only) Prior treatment with anti-LAG-3 agents
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- Patients with lung cancer that have epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, unless disease has progressed following available EGFR or ALK targeted therapy
- Presence of other active invasive cancers other than the one treated in this Trial within 5 years Prior to screening, with the exception of appropriately treated basal or squamous-cell carcinoma of the skin or in situ carcinoma of the uterine cervix, or other local tumours considered cured by local treatment
- Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of PD by imaging for at least 4 weeks prior to the first dose of trial treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases
- Inadequate organ function or bone marrow reserve as demonstrated by the following laboratory values:
- Absolute neutrophil count <1.5 x 10^9/L (<1500/mm^3)
- Platelet count <100 x 10^9/L (<100,000/mm^3)
- Haemoglobin <9.0 g/dL
- Alanine aminotransferase (ALT) >2.5 times the upper limit of normal (ULN) if no demonstrable liver lesion(s) (primary or metastases) or >5 times ULN in the presence of liver lesion(s)
- Aspartate aminotransferase (AST) >2.5 times ULN if no demonstrable liver lesion(s) or >5 times ULN in the presence of liver lesion(s)
- Total bilirubin >1.5 times ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin >3.0 times ULN or direct bilirubin >1.5 times ULN
- Serum creatinine (measured by enzymatic assay, Isotope dilution mass spectroscopy [IDMS] standardized Jaffe assay, or non-IDMS Jaffe assay) >1.5 times ULN or estimated glomerular filtration rate (eGFR) <30mL/min/1.73m^2 (Chronic Kidney Disease Epidemiology [CKD-EPI] Collaboration equation); confirmation of eGFR is only required when creatinine is >1.5 X ULN
- International normalized ratio (INR) (only tested if clinically indicated) >1.5 times ULN (if treated with anticoagulants, prolonged INR is acceptable)
- Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) >470 msec
- Any clinically important abnormalities (as assessed by the investigator) in rhythm, conduction, or morphology of resting ECGs, e.g., complete left bundle branch block, third degree heart block
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval
- Patients with an ejection fraction <55% or the lower limit of normal of the institutional standard will be excluded. Only in cases where the Investigator (or the treating physician or both) suspects cardiac disease with negative effect on the EF, will the EF be measured during screening using an appropriate method according to local standards to confirm eligibility (e.g., echocardiogram [ECHO], multi-gated acquisition scan [MUGA]). A historic measurement of EF no older than 6 months prior to first administration of study drug can be accepted provided that there is clinical evidence that the EF value has not worsened since this measurement in the opinion of the Investigator or of the treating physician or both.
- History of pneumonitis within the last 5 years
- History of severe hypersensitivity reactions to other mAbs
- History of severe hypersensitivity reactions to the ingredients of study drug
- Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study treatment
- Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy, or asthma well controlled with steroids
- Active infection requiring systemic treatment (antibacterial, antiviral, or antifungal therapy) at start of treatment in this trial
- Known history of human immunodeficiency virus (HIV) infection or laboratory evidence of hepatitis virus infection with positive results of hepatitis B surface (HBs) antigen and/or presence of HBc antibody together with HBV-DNA and/or hepatitis C RNA (HIV and hepatitis test results obtained in routine diagnostics are acceptable if done within 14 days before the informed consent date). However, for patients with hepatocellular cancer in Part III Cohorts C and D, patients with HBV and/or HCV infection are allowed. Hepatocellular cancer patients in Part III Cohorts C and D with HBV infection must be receiving effective antiviral therapy (viral load <100 IU/mL)
- Current or history of interstitial lung disease
- Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes him/her an unreliable trial patient, unlikely to complete the trial, or unable to comply with the protocol procedures. However, for patients with hepatocellular cancer in Part III Cohorts C and D, past chronic alcohol abuse are allowed
- Women who are pregnant, nursing, or who plan to become pregnant during the trial
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Japan6 sites
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
Kanagawa Cancer Center
Kanagawa, Yokohama, 241-8515
Saitama Cancer Center
Saitama, Kitaadachi-gun, 362-0806
Shizuoka Cancer Center
Shizuoka, Sunto-gun, 411-8777
National Cancer Center Hospital
Tokyo, Chuo-ku, 104-0045
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
Taiwan4 sites
NCKUH
Tainan, 70403
National Taiwan University Hospital
Taipei, 10002
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Memorial Hospital(Linkou)
Taoyuan, 333
South Korea3 sites
Seoul National University Hospital
Seoul, 03080
Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
About this study
Official title: An Open Label, Phase I Study of BI 754091 Monotherapy and Combination Therapy of BI 754091 and BI 754111 in Asian Patients With Advanced Solid Tumours
The main objectives of the BI 754091 monotherapy dose-finding part (Part I) of the trial are to investigate the following items in advanced solid tumours:
- Safety, tolerability, and pharmacokinetics (PK) of BI 754091 as monotherapy.
- Maximum tolerated dose (MTD) and/or recommended dose (RD) of BI 754091 monotherapy.
Read more
The main objectives of the Combination dose-finding part (Part II) of the trial are to investigate the following items in advanced solid tumours:
- Safety, tolerability, and PK of the combination treatment of BI 754091 and BI 754111.
- MTD and/or RD of the combination treatment of BI 754091 and BI 754111.
The main objectives of the expansion part (Part III) of the trial are:
- To further investigate the safety, tolerability, and PK of the RD of BI 754091 and BI 754111 combination in patients with gastric/esophagogastric junction cancer, esophageal cancer, hepatocellular cancer or non-small cell lung cancer (NSCLC)
- To explore the efficacy of the RD of the combination of BI 754091 and BI 754111 in patients with gastric/esophagogastric junction cancer, esophageal cancer, hepatocellular cancer or NSCLC
- Conditions
- Neoplasms
- Being tested
- Ezabenlimab, BI 754111
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzabenlimabDrug
Also called BI 754091
Solution for infusion
BI 754111Drug
Solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Part I - ezabenlimab 240 mg | Experimental | Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours were administered via intravenous infusion with ezabenlimab 240 milligram (mg) on day 1 of each 3-week (21 days) cycle.
Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. Receives: Drug: Ezabenlimab |
| Part II - ezabenlimab 240 mg + BI 754111 400 mg | Experimental | Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours were administered via intravenous infusion with ezabenlimab 240 milligram (mg) and BI 754111 400 mg on day 1 of each 3-week (21 days) cycle.
Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. Receives: Drug: Ezabenlimab; Drug: BI 754111 |
| Part II - ezabenlimab 240 mg + BI 754111 600 mg | Experimental | Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours were administered via intravenous infusion with ezabenlimab 240 milligram (mg) and BI 754111 600 mg on day 1 of each 3-week (21 days) cycle.
Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. Receives: Drug: Ezabenlimab; Drug: BI 754111 |
| Part II - ezabenlimab 240 mg + BI 754111 800 mg | Experimental | Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours were administered via intravenous infusion with ezabenlimab 240 milligram (mg) and BI 754111 800 mg on day 1 of each 3-week (21 days) cycle.
Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. Receives: Drug: Ezabenlimab; Drug: BI 754111 |
| Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort A | Experimental | Patients with gastric/esophagogastric junction cancer, with no prior treatment with anti-Programmed cell death protein-1 (PD-1)/Programmed death ligand-1 (PD-L1) antibody, and who had received at least one line of systemic anticancer treatment, excluding adjuvant therapy, were administered via intravenous infusion with ezabenlimab 240 milligram (mg) and BI 754111 600 mg on day 1 of each 3-week (21 days) cycle.
Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. Receives: Drug: Ezabenlimab; Drug: BI 754111 |
| Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort B | Experimental | Patients with esophageal cancer, with no prior treatment with anti-Programmed cell death protein-1 (PD-1)/Programmed death ligand-1 (PD-L1) antibody, and who had received at least one line of systemic anticancer treatment, excluding adjuvant therapy, were administered via intravenous infusion with ezabenlimab 240 milligram (mg) and BI 754111 600 mg on day 1 of each 3-week (21 days) cycle.
Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. Receives: Drug: Ezabenlimab; Drug: BI 754111 |
| Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort C | Experimental | Patients with hepatocellular cancer, with no prior treatment with anti-Programmed cell death protein-1 (PD-1)/Programmed death ligand-1 (PD-L1) antibody, who received at least one line of systemic anticancer treatment, excluding adjuvant therapy, and whose Child-Pugh score is ≤7, were administered via intravenous infusion with ezabenlimab 240 milligram (mg) and BI 754111 600 mg on day 1 of each 3-week (21 days) cycle.
Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. Receives: Drug: Ezabenlimab; Drug: BI 754111 |
| Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort D | Experimental | Patients with gastric/esophagogastric junction cancer, esophageal cancer, or hepatocellular cancer, with a prior treatment with anti-Programmed cell death protein-1 (PD-1)/Programmed death ligand-1 (PD-L1) antibody, were administered via intravenous infusion with ezabenlimab 240 milligram (mg) and BI 754111 600 mg on day 1 of each 3-week (21 days) cycle.
Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. Receives: Drug: Ezabenlimab; Drug: BI 754111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part I: Maximum Tolerated Dose (MTD) of Ezabenlimab
MTD is defined as the highest dose for a given schedule expected to cause <25% risk of the true dose limiting toxicity (DLT) rate being ≥33% during the MTD evaluation period.
Haematologic DLTs: any Grade 5 toxicity; neutropenia ≥Grade 4 for >5 days; any duration Febrile neutropenia; grade 4 thrombocytopenia or Grade 3 with bleeding or requiring platelet transfusions (any Grade); unexplained Grade 4 anaemia or requiring blood transfusions (any Grade).
Non-haematological DLTs: aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >3x Upper limit of normal (ULN) and total bilirubin >2x ULN without cholestasis signs; any duration ≥Grade 4 AST or ALT; any ≥Grade 3 non-haematologic toxicity with exceptions; any Grade 4 or 5 adverse event; any duration any Grade 2 pneumonitis; any Grade 2 uveitis, eye pain, or blurred vision not improving to Grade 1 within 2 weeks or requiring systemic treatment; any ≥Grade 2 toxicity causing inability to administer trial drug on Cycle 2 Day 1.
Measured: First cycle of treatment: 3 weeks (21 days) following drug administration.
Part I: Number of Patients Experiencing DLTs During the MTD Evaluation Period (First Cycle of Treatment)
Number of patients experiencing DLTs during the MTD evaluation period (first cycle of treatment) is reported.
Measured: First cycle of treatment: 3 weeks (21 days) following drug administration.
Part II: MTD of the Ezabenlimab Plus BI 754111 Combination Therapy
MTD is defined as the highest dose for a given schedule expected to cause <25% risk of the true DLT rate being ≥33% during the MTD evaluation period.
Haematologic DLTs: any Grade 5 toxicity; neutropenia ≥Grade 4 for >5 days; any duration Febrile neutropenia; grade 4 thrombocytopenia or Grade 3 with bleeding or requiring platelet transfusions (any Grade); unexplained Grade 4 anaemia or requiring blood transfusions (any Grade).
Non-haematological DLTs: aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >3x Upper limit of normal (ULN) and total bilirubin >2x ULN without cholestasis signs; any duration ≥Grade 4 AST or ALT; any ≥Grade 3 non-haematologic toxicity with exceptions; any Grade 4 or 5 adverse event; any duration any Grade 2 pneumonitis; any Grade 2 uveitis, eye pain, or blurred vision not improving to Grade 1 within 2 weeks or requiring systemic treatment; any ≥Grade 2 toxicity causing inability to administer trial drugs on Cycle 2 Day 1.
Measured: First cycle of treatment: 3 weeks (21 days) following drug administration.
Part II: Number of Patients Experiencing DLTs During the MTD Evaluation Period (First Cycle of Treatment)
Number of patients experiencing DLTs during the MTD evaluation period (first cycle of treatment) is reported.
Measured: First cycle of treatment: 3 weeks (21 days) following drug administration.
Part III: Number of Patients With Objective Response (OR) - Confirmed Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 as Assessed by the Investigator
Number of patients with objective response (OR) - confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumours (RECIST) Version 1.1 as assessed by the Investigator, is reported.
CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm).
PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period): up to 49 months.
Secondary outcomes (10)
Part III: Duration of Response
The duration of response, defined as the interval from the date of first documented PR or CR according to RECIST Version 1.1 as assessed by the Investigator, to the date of progressive disease (PD) or death, is reported.
For all patients with an OR, the duration of OR was calculated as follows:
- for patients with PD or death: duration of response [days] = date of outcome - date of first assessment indicating OR + 1,
- for patients without PD or death: duration of response (censored) [days] = date of outcome - date of first assessment indicating OR + 1, for patients without disease progression or death.
Kaplan-Meier estimates were used to calculate median duration of OR.
Measured: From the date of objective response until first date that death or PD has been documented, up to 1362 days.
Part III: Number of Patients With Disease Control
Number of patients with disease control is reported. Disease control: CR, PR, or stable disease (SD) according to RECIST Version 1.1 as assessed by the Investigator.
SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period): up to 49 months.
Part I: Number of Patients With OR: Confirmed CR or PR According to RECIST v1.1 as Assessed by the Investigator
Number of patients with OR: confirmed CR or PR according to RECIST v1.1 as assessed by the Investigator, is reported.
CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period): 180 days.
Part II: Number of Patients With OR: Confirmed CR or PR According to RECIST v1.1 as Assessed by the Investigator
Number of patients with OR: confirmed CR or PR according to RECIST v1.1 as assessed by the Investigator, is reported.
CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period): up to 389 days.
Part I: Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) in the First Cycle of Treatment
Maximum measured concentration of ezabenlimab in plasma (Cmax) in the first cycle of treatment (21 days following drug administration) is reported.
Measured: 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment.
Part II: Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) in the First Cycle of Treatment
Maximum measured concentration of ezabenlimab in plasma (Cmax) in the first cycle of treatment (21 days following drug administration) is reported.
Measured: 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment.
Part II: Maximum Measured Concentration of BI 754111 in Plasma (Cmax) in the First Cycle of Treatment
Maximum measured concentration of BI 754111 in plasma (Cmax) in the first cycle of treatment (21 days following drug administration) is reported.
Measured: 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment.
Part I: Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504) in the First Cycle of Treatment
Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504) in the first cycle of treatment (21 days following drug administration) is reported.
Measured: 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment.
Part II: Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504) in the First Cycle of Treatment
Area under the concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504) in the first cycle of treatment (21 days following drug administration) is reported.
Measured: 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment.
Part II: Area Under the Concentration-time Curve of BI 754111 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504) in the First Cycle of Treatment
Area under the concentration-time curve of BI 754111 in plasma over the time interval from 0 to 504 hours (AUC0-504) in the first cycle of treatment (21 days following drug administration) is reported.
Measured: 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start23 Feb 2018
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433898
- Sponsor's protocol ID
- 1381-0004
- Status last verified
- Oct 2025
- First submitted
- 9 Feb 2018
- Last updated
- 19 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1\. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
Publications
Zettl M, Wurm M, Schaaf O, Mostbock S, Tirapu I, Apfler I, Lorenz IC, Frego L, Kenny C, Thibodeau M, Oquendo Cifuentes E, Reschke M, Moll J, Kraut N, Vogt A, Sedgwick JD, Waizenegger IC. Combination of two novel blocking antibodies, anti-PD-1 antibody ezabenlimab (BI 754091) and anti-LAG-3 antibody BI 754111, leads to increased immune cell responses. Oncoimmunology. 2022 Jun 16;11(1):2080328. doi: 10.1080/2162402X.2022.2080328. eCollection 2022.
PubMed 35756842
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Phase I Study of BI 754091 Monotherapy and Combination Therapy of BI 754091 and BI 754111 in Asian Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT03433898
- Acronym / sponsor ID
- 1381-0004
- Conditions
- Neoplasms
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Posted 19 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objectives of the BI 754091 monotherapy dose-finding part (Part I) of the trial are to investigate the following items in advanced solid tumours:
- Safety, tolerability, and pharmacokinetics (PK) of BI 754091 as monotherapy.
- Maximum tolerated dose (MTD) and/or recommended dose (RD) of BI 754091 monotherapy.
The main objectives of the Combination dose-finding part (Part II) of the trial are to investigate the following items in advanced solid tumours:
- Safety, tolerability, and PK of the combination treatment of BI 754091 and BI 754111.
- MTD and/or RD of the combination treatment of BI 754091 and BI 754111.
The main objectives of the expansion part (Part III) of the trial are:
- To further investigate the safety, tolerability, and PK of the RD of BI 754091 and BI 754111 combination in patients with gastric/esophagogastric junction cancer, esophageal cancer, hepatocellular cancer or non-small cell lung cancer (NSCLC)
- To explore the efficacy of the RD of the combination of BI 754091 and BI 754111 in patients with gastric/esophagogastric junction cancer, esophageal cancer, hepatocellular cancer or NSCLC
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part I - ezabenlimab 240 mg | Experimental | Drug: EzabenlimabPatients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours were administered via intravenous infusion with ezabenlimab 240 milligram (mg) on day 1 of each 3-week (21 days) cycle. Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. |
| Part II - ezabenlimab 240 mg + BI 754111 400 mg | Experimental | Drug: Ezabenlimab, Drug: BI 754111Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours were administered via intravenous infusion with ezabenlimab 240 milligram (mg) and BI 754111 400 mg on day 1 of each 3-week (21 days) cycle. Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. |
| Part II - ezabenlimab 240 mg + BI 754111 600 mg | Experimental | Drug: Ezabenlimab, Drug: BI 754111Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours were administered via intravenous infusion with ezabenlimab 240 milligram (mg) and BI 754111 600 mg on day 1 of each 3-week (21 days) cycle. Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. |
| Part II - ezabenlimab 240 mg + BI 754111 800 mg | Experimental | Drug: Ezabenlimab, Drug: BI 754111Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours were administered via intravenous infusion with ezabenlimab 240 milligram (mg) and BI 754111 800 mg on day 1 of each 3-week (21 days) cycle. Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. |
| Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort A | Experimental | Drug: Ezabenlimab, Drug: BI 754111Patients with gastric/esophagogastric junction cancer, with no prior treatment with anti-Programmed cell death protein-1 (PD-1)/Programmed death ligand-1 (PD-L1) antibody, and who had received at least one line of systemic anticancer treatment, excluding adjuvant therapy, were administered via intravenous infusion with ezabenlimab 240 milligram (mg) and BI 754111 600 mg on day 1 of each 3-week (21 days) cycle. Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. |
| Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort B | Experimental | Drug: Ezabenlimab, Drug: BI 754111Patients with esophageal cancer, with no prior treatment with anti-Programmed cell death protein-1 (PD-1)/Programmed death ligand-1 (PD-L1) antibody, and who had received at least one line of systemic anticancer treatment, excluding adjuvant therapy, were administered via intravenous infusion with ezabenlimab 240 milligram (mg) and BI 754111 600 mg on day 1 of each 3-week (21 days) cycle. Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. |
| Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort C | Experimental | Drug: Ezabenlimab, Drug: BI 754111Patients with hepatocellular cancer, with no prior treatment with anti-Programmed cell death protein-1 (PD-1)/Programmed death ligand-1 (PD-L1) antibody, who received at least one line of systemic anticancer treatment, excluding adjuvant therapy, and whose Child-Pugh score is ≤7, were administered via intravenous infusion with ezabenlimab 240 milligram (mg) and BI 754111 600 mg on day 1 of each 3-week (21 days) cycle. Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. |
| Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort D | Experimental | Drug: Ezabenlimab, Drug: BI 754111Patients with gastric/esophagogastric junction cancer, esophageal cancer, or hepatocellular cancer, with a prior treatment with anti-Programmed cell death protein-1 (PD-1)/Programmed death ligand-1 (PD-L1) antibody, were administered via intravenous infusion with ezabenlimab 240 milligram (mg) and BI 754111 600 mg on day 1 of each 3-week (21 days) cycle. Administration was continued until progressive disease, unacceptable toxicity, other withdrawal criteria, or a maximum treatment duration of 1 year. If the patient was benefiting clinically at 1 year, he/she could continue after a case-by-case review with the sponsor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Of full age (according to local legislation) at the time of signing of the informed consent form (ICF)
- Women of childbearing potential (WOCBP)1 with negative serum pregnancy test at screening and men able to father a child, who agree to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information. The requirement of contraception does not apply to women of no childbearing potential but they must have an evidence of such at screening
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Patients with measurable lesions according to RECIST v1.1
- Conditions specific to respective part of the trial:
Key exclusion criteria (33 listed)
- Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to study entry or planned within 12 months after screening, e.g. hip replacement
- Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
- Previous treatment with study medications in this trial
- Any investigational or anti-tumour treatment within 4 weeks or 5 half-life periods (whichever is shorter) prior to the initiation of trial treatment
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 neuropathy due to prior platinum-based therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EzabenlimabAlso: BI 754091Solution for infusion | Drug | Part I - ezabenlimab 240 mg, Part II - ezabenlimab 240 mg + BI 754111 400 mg, Part II - ezabenlimab 240 mg + BI 754111 600 mg, Part II - ezabenlimab 240 mg + BI 754111 800 mg, Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort A, Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort B, Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort C, Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort D |
| BI 754111Solution for infusion | Drug | Part II - ezabenlimab 240 mg + BI 754111 400 mg, Part II - ezabenlimab 240 mg + BI 754111 600 mg, Part II - ezabenlimab 240 mg + BI 754111 800 mg, Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort A, Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort B, Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort C, Part III - ezabenlimab 240 mg + BI 754111 600 mg, cohort D |
Primary outcome
Part I: Maximum Tolerated Dose (MTD) of Ezabenlimab
Time frame: First cycle of treatment: 3 weeks (21 days) following drug administration.
MTD is defined as the highest dose for a given schedule expected to cause <25% risk of the true dose limiting toxicity (DLT) rate being ≥33% during the MTD evaluation period. Haematologic DLTs: any Grade 5 toxicity; neutropenia ≥Grade 4 for >5 days; any duration Febrile neutropenia; grade 4 thrombocytopenia or Grade 3 with bleeding or requiring platelet transfusions (any Grade); unexplained Grade 4 anaemia or requiring blood transfusions (any Grade). Non-haematological DLTs: aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >3x Upper limit of normal (ULN) and total bilirubin >2x ULN without cholestasis signs; any duration ≥Grade 4 AST or ALT; any ≥Grade 3 non-haematologic toxicity with exceptions; any Grade 4 or 5 adverse event; any duration any Grade 2 pneumonitis; any Grade 2 uveitis, eye pain, or blurred vision not improving to Grade 1 within 2 weeks or requiring systemic treatment; any ≥Grade 2 toxicity causing inability to administer trial drug on Cycle 2 Day 1.
Part I: Number of Patients Experiencing DLTs During the MTD Evaluation Period (First Cycle of Treatment)
Time frame: First cycle of treatment: 3 weeks (21 days) following drug administration.
Number of patients experiencing DLTs during the MTD evaluation period (first cycle of treatment) is reported.
Part II: MTD of the Ezabenlimab Plus BI 754111 Combination Therapy
Time frame: First cycle of treatment: 3 weeks (21 days) following drug administration.
MTD is defined as the highest dose for a given schedule expected to cause <25% risk of the true DLT rate being ≥33% during the MTD evaluation period. Haematologic DLTs: any Grade 5 toxicity; neutropenia ≥Grade 4 for >5 days; any duration Febrile neutropenia; grade 4 thrombocytopenia or Grade 3 with bleeding or requiring platelet transfusions (any Grade); unexplained Grade 4 anaemia or requiring blood transfusions (any Grade). Non-haematological DLTs: aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >3x Upper limit of normal (ULN) and total bilirubin >2x ULN without cholestasis signs; any duration ≥Grade 4 AST or ALT; any ≥Grade 3 non-haematologic toxicity with exceptions; any Grade 4 or 5 adverse event; any duration any Grade 2 pneumonitis; any Grade 2 uveitis, eye pain, or blurred vision not improving to Grade 1 within 2 weeks or requiring systemic treatment; any ≥Grade 2 toxicity causing inability to administer trial drugs on Cycle 2 Day 1.
Part II: Number of Patients Experiencing DLTs During the MTD Evaluation Period (First Cycle of Treatment)
Time frame: First cycle of treatment: 3 weeks (21 days) following drug administration.
Number of patients experiencing DLTs during the MTD evaluation period (first cycle of treatment) is reported.
Part III: Number of Patients With Objective Response (OR) - Confirmed Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1 as Assessed by the Investigator
Time frame: From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period): up to 49 months.
Number of patients with objective response (OR) - confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumours (RECIST) Version 1.1 as assessed by the Investigator, is reported. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm). PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
10 secondary outcomes
Part III: Duration of Response
Time frame: From the date of objective response until first date that death or PD has been documented, up to 1362 days.
Part III: Number of Patients With Disease Control
Time frame: From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period): up to 49 months.
Part I: Number of Patients With OR: Confirmed CR or PR According to RECIST v1.1 as Assessed by the Investigator
Time frame: From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period): 180 days.
Part II: Number of Patients With OR: Confirmed CR or PR According to RECIST v1.1 as Assessed by the Investigator
Time frame: From the date of the first administration of trial treatment until the date of the last administration of trial treatment + 30 days (residual effect period): up to 389 days.
Part I: Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) in the First Cycle of Treatment
Time frame: 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment.
Part II: Maximum Measured Concentration of Ezabenlimab in Plasma (Cmax) in the First Cycle of Treatment
Time frame: 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment.
Part II: Maximum Measured Concentration of BI 754111 in Plasma (Cmax) in the First Cycle of Treatment
Time frame: 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment.
Part I: Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504) in the First Cycle of Treatment
Time frame: 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment.
Part II: Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504) in the First Cycle of Treatment
Time frame: 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment.
Part II: Area Under the Concentration-time Curve of BI 754111 in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504) in the First Cycle of Treatment
Time frame: 5 minutes before drug administration and 1, 1.5, 2, 4, 7, 24, 48, 72, 168, 336 and 504 hours (h) after the start of drug administration in the first cycle of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35756842Zettl M, Wurm M, Schaaf O, Mostbock S, Tirapu I, Apfler I, Lorenz IC, Frego L, Kenny C, Thibodeau M, Oquendo Cifuentes E, Reschke M, Moll J, Kraut N, Vogt A, Sedgwick JD, Waizenegger IC. Combination of two novel blocking antibodies, anti-PD-1 antibody ezabenlimab (BI 754091) and anti-LAG-3 antibody BI 754111, leads to increased immune cell responses. Oncoimmunology. 2022 Jun 16;11(1):2080328. doi: 10.1080/2162402X.2022.2080328. eCollection 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ezabenlimab and BI 754111 in people with Neoplasms, run by Boehringer Ingelheim at 13 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Japan, Taiwan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part I: Maximum Tolerated Dose (MTD) of Ezabenlimab (time frame: First cycle of treatment: 3 weeks (21 days) following drug administration.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03433898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.