Solid TumorsPhase 1/2NCT06205706
BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors
A Phase 1/2 study testing BI-1910 and Pembrolizumab in people with Solid Tumors and Non Small Cell Lung Cancer, run by BioInvent International AB at 8 sites in 4 countries.
Trial summary
The goal of this first in human clinical trial is to test BI-1910 administered as single agent and in combination with pembrolizumab in subjects with advanced/metastatic solid tumors whose disease has progressed after standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Non Small Cell Lung Cancer, Hepatocellular Carcinoma
- What is being tested?
- BI-1910 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 4 Dec 2023to 7 Nov 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Is willing and able to provide signed informed consent for the trial.
- Is ≥18 years of age on the day of signing the informed consent form.
- Has a histologically-confirmed advanced/metastatic solid tumor.
- Has received standard of care and progressed or is intolerant of, or is not eligible to receive standard of care antineoplastic therapy.
- Has at least 1 measurable disease lesion as defined by RECIST v1.1.
- Must be willing to provide tumor biopsies as specified in the schedule of assessments
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- Has a life expectancy of ≥12 weeks.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has adequate organ function as confirmed by laboratory values.
Who cannot join
- Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has known or suspected hypersensitivity to BI-1910 or pembrolizumab.
- Has cardiac or renal amyloid light-chain amyloidosis.
- Has received the following:
- Chemotherapy or small molecule anti-cancer therapy products within 4 weeks, or 5 half-lives of the respective drug whichever is longer, of first dose of BI-1910.
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- Radiotherapy within 2 weeks of first dose of BI-1910. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) for non-CNS disease.
- Subjects who have previously had radiation pneumonitis are not allowed.
- Immunotherapy within 4 weeks prior to the first dose of BI-1910.
- Has not recovered from AEs to at least Grade 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v5.0 or higher).
- Has had Grade ≥3 autoimmune manifestations of previous immune checkpoint inhibitor treatments (e.g., anti-PD-1, anti-PD-L1, or anti-CTLA-4).
- Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active, known, or suspected autoimmune disease.
- Is a female subject and has the ability to become pregnant (or already pregnant or lactating/breastfeeding). However, those female subjects who have a negative serum or urine pregnancy test up to 72 hours prior to their first dose of study treatment and agree to use a highly effective method of birth control for 4 weeks before entering the trial, during the trial, and for 12 months after their last dose of study treatment are considered eligible.
- Is a male subject with partner(s) of childbearing potential (unless he agrees to use a barrier method of contraception [condom plus spermicidal gel] with the female partner(s) who are using one highly effective method of contraception during the trial and for 12 months after completing treatment).
- Has had major surgery from which the subject has not yet recovered.
- Is at high medical risk because of nonmalignant systemic disease including severe active infections on treatment with antibiotics, antifungals, or antivirals other than the ones considered adequate for treatment of HBV.
- Has presence of chronic graft versus host disease.
- Has had an allogenic tissue/solid organ transplant.
- Is positive for Human Immunodeficiency Virus (HIV).
- Has history of chronic HBV or HCV infections.
- Has a history of active tuberculosis (Bacillus tuberculosis).
- Has received a live vaccine within 30 days before the first dose of study treatment.
- Has uncontrolled or significant cardiovascular disease.
- Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the trial.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
- Is participating or planning to participate in another interventional clinical trial or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study treatment.
- Has a known additional malignancy of another type, with the exception of adequately treated cone-biopsied carcinoma in situ and basal or squamous cell carcinoma of the skin. Male subjects with asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate-specific antigen for >1 year prior to start of study treatment are eligible.
- Has a confirmed diagnosis of primary immunodeficiency or an acquired condition that leads to an immunodeficiency disorder or taking any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment.
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Spain4 sites
Hospital HM Nou Delfos
Barcelona, 08023
HM Sanchinarro
Madrid
Hospital Fundacion Jimenez Diaz
Madrid
Hospital universitario Virgen del Rocio
Seville
Sweden2 sites
Lund University Hospital
Lund
Karolinska University Hospital, Solna
Stockholm
About this study
Official title: Phase 1/2a Open-Label, Dose-Escalation, Multicenter, First-in-Human, Consecutive-Cohort, Clinical Trial of BI-1910, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2), as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
The goal of this first in human clinical trial is to test BI-1910 administered as single agent and in combination with pembrolizumab in subjects with advanced/metastatic solid tumors whose disease has progressed after standard therapy.
The main questions it aims to answer are:
- how safe and tolerable is BI-1910
- what is maximum tolerated or administrated dose
- to determine recommended dose for further clinical trials
Participants will receive infusions of BI-1910 alone or combination with pembrolizumab every 3 weeks.
Read the detailed description
This is a Phase 1/2a, open-label, dose-escalation, multicenter, FIH, consecutive-cohort, clinical trial of BI-1910, as a single agent and in combination with pembrolizumab, in subjects with advanced/metastatic solid tumors whose disease has progressed after standard therapy.
The trial comprises 2 phases: a Phase 1 with Parts A and B, and a Phase 2a with Parts A and B.
Phase 1 Part A consists of a dose escalation of BI-1910 as a single agent to evaluate safety and tolerability and to determine the RP2D as a single agent (sRP2D) in subjects with advanced/metastatic solid tumors whose disease has progressed after standard therapy.
Phase 1 Part B consists of a dose escalation of BI-1910 in combination with pembrolizumab to evaluate the safety and tolerability of the combination treatment and to allow selection of the RP2D for BI-1910 in combination with pembrolizumab (cRP2D) in subjects with advanced/metastatic solid tumors whose disease has progressed after standard therapy.
Phase 2a will assess BI-1910 administered as a single agent (Part A) and in combination with pembrolizumab (Part B) at the respective hypothesized RP2D(s) determined in Phase 1. Phase 2a expansion will be conducted in indication specific cohorts of subjects. The aim of the Phase 2a is to urther assess the safety and tolerability of BI-1910 as a single agent (Part A) and in combination with pembrolizumab (Part B), characterize its PK and pharmacodynamics, and assess preliminary antitumor activity by ORR, DoR, and progression-free survival (PFS), as measured by RECIST v1.1 and iRECIST.
- Being tested
- BI-1910, Pembrolizumab
- Keywords
- solid tumors
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI-1910Drug
BI-1910 administered as a flat-dose IV infusion once every 3 weeks
PembrolizumabDrug
Pembrolizumab be administered as an IV infusion at its standard flat dose (200 mg) once every 3 weeks prior to the BI-1910 infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase I, Part A - Dose escalation and safety of BI-1910 as single agent | Experimental | Dose escalation of BI-1910 administered as a single agent. Receives: Drug: BI-1910 |
| Phase I, Part B - Dose escalation and safety of BI-1910 in combination with pembrolizumab | Experimental | Dose escalation of BI-1910 in combination with pembrolizumab. Receives: Drug: BI-1910; Drug: Pembrolizumab |
| Phase 2a, Part A - Dose expansion of BI-1910 as single agent | Experimental | BI-1910 administered as a single agent at the hypothesized recommended phase 2 dose determined in Phase 1. Receives: Drug: BI-1910 |
| Phase 2a, Part B - Dose expansion of BI-1910 | Experimental | BI-1910 administered in combination with pembrolizumab at the respective hypothesized recommended phase 2 doses determined in Phase 1 Receives: Drug: BI-1910; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events (AEs)
AEs will be assessed by the investigators by severity and will be graded according to the NCI CTCAE v5.0 or higher and causality between AEs and the exposure to the study treatment.
Measured: From the start of the study treatment for up to 2 years and 90 days.
Occurrence of serious adverse events (SAEs)
SAEs will be assessed by the investigators by severity and will be graded according to the NCI CTCAE v5.0 or higher and causality between SAEs and the exposure to the study treatment
Measured: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Frequency of AEs leading to discontinuation of study treatment
All adverse events leading to premature study treatment discontinuation will be analyzed descriptively utilizing corresponding MedDRA, System Organ Classes, and Preferred Terms.
Measured: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Frequency of dose interruptions and dose reductions.
Study treatment modifications will be summarized in 2 categories: dose reduction and dose interruptions. The number and percentage of subjects who have any dose reduction or interruption and have at least 1 dose reduction or interruption will be summarized. Lastly, the primary reason for each form of study treatment modification will also be summarized.
Measured: From the start of the study treatment for up to 2 years
Changes from baseline in laboratory parameters
These include clinical laboratory assessments (hematology, clinical chemistry, urinalysis), additional CRP assessment, coagulation, thyroid, pregnancy, and viral serology assessments Safety laboratory results will be graded by NCI CTCAE v5.0 (or higher). If no grading exists, values will be classified into low/normal/high based on laboratory normal ranges. Each parameter will be presented by descriptive statistics at each visit, including change from baseline.
Measured: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Changes from baseline in temperature (C or F)
Temperature (C or F) will be measured in a seated or supine position after 5 minutes' rest and will be summarized by descriptive statistics at each visit, including change from baseline.
Measured: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Changes from baseline in Respiratory Rate (Breaths/Min)
Respiratory rate (breaths/min) will be measured in a seated or supine position after 5 minutes' rest and will be summarized by descriptive statistics at each visit, including change from baseline.
Measured: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Changes from baseline in Blood Pressure (mmHg)
Systolic and diastolic blood pressure (mmHg) will be measured in a seated or supine position after 5 minutes' rest and will be summarized by descriptive statistics at each visit, including change from baseline.
Measured: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Changes from baseline in O2 Saturation (%)
O2 Saturation (%) will be measured in a seated or supine position after 5 minutes' rest and will be summarized by descriptive statistics at each visit, including change from baseline.
Measured: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Changes from baseline in weight
Weight (kg or lb) and body surface area (m2) will be collected at Screening and on each dose day before any study treatment is administered and will be summarized by descriptive statistics at each visit, including change from baseline. Height (cm or in) will be recorded at baseline only
Measured: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Occurrence of dose limiting toxicities (DLTs)
All adverse events meeting the DLT criteria will be considered a DLT potentially related to the study treatment, regardless of Investigator/Sponsor causality assessment, excluding toxicities that are clearly related to disease progression or inter-current illness. DLTs will be considered by the safety monitoring committee for the purposes of dosing decisions.
Measured: During phase 1 Part A: from the first dose of BI-1910 for 21 days. During phase 1 part B: from the first dose of BI-1910 for 42 days.
identification of dose/dose range fulfilling favorable PK and pharmacodynamic profile, with acceptable safety
based on the totality of the efficacy, safety, PK, and pharmacodynamic endpoints
Measured: During phase 2a from screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Secondary outcomes (7)
Maximum Concentration (Cmax) of BI-1910
Maximum concentration (Cmax), obtained directly from the observed concentration-versus-time data will be determined.
Measured: From the start of the study treatment for up to 2 years and 90 days.
Serum concentration-time curve [AUC] of BI-1910
Area under the serum concentration-time curve will be determined.
Measured: From the start of the study treatment for up to 2 years and 90 days.
Terminal half-life (t½) of BI-1910
Terminal half-life will be determined, a minimum of 3 points will be used for estimation
Measured: From the start of the study treatment for up to 2 years and 90 days.
Recommended dose range (RDR)
RDR is defined as the range between the minimal reproducibly active dose (MRAD), and the MTD or MAD. MRAD is the lowest dose level at which subjects experience tumor shrinkage and/or relevant PK/pharmacodynamic parameters indicate biological activity.
Measured: During phase 1 From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Incidence and titer of antidrug antibodies (ADAs).
The detection and characterization of antibodies to BI-1910 will be performed. The samples collected will also be evaluated or BI-1910 serum concentration to enable interpretation of the antibody data. Antibodies may be further characterized and/or evaluated for their ability to neutralize the activity of the study treatments.
Measured: From the start of the study treatment for up to 2 years and 90 days.
Objective response rate (ORR).
Objective response rate based on the best objective response, defined as achieving confirmed CR and/or PR measured by RECIST 1.1 and iRECIST,
Measured: During phase 2a from from the start of the study treatment for up to 2 years and 30 days
Duration of response (DoR).
Defined as the time from the first assessment of PR or CR to the follow-up first assessment of PD measured by RECIST 1.1 and iRECIST.
Measured: During phase 2a from from the start of the study treatment for up to 2 years and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start4 Dec 2023
- Primary completion14 Jul 2027 (estimated)
- Study completion7 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a Phase 1/2a, open-label, dose-escalation, multicenter, FIH, consecutive-cohort, clinical trial of BI-1910, as a single agent and in combination with pembrolizumab.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioInvent International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Andres McAllister, PhD, Study director, BioInvent International AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205706
- Sponsor's protocol ID
- 22-BI-1910-01
- Other IDs
- U1111-1293-2634, 2022-503066-74-00, KEYNOTE F82
- Status last verified
- Sep 2025
- First submitted
- 18 Dec 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2a Open-Label, Dose-Escalation, Multicenter, First-in-Human, Consecutive-Cohort, Clinical Trial of BI-1910, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2), as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06205706
- Acronym / sponsor ID
- 22-BI-1910-01
- Keywords
- solid tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- BioInvent International ABIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 14 Jul 2027 (estimated)
- Study completion
- 7 Nov 2028 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this first in human clinical trial is to test BI-1910 administered as single agent and in combination with pembrolizumab in subjects with advanced/metastatic solid tumors whose disease has progressed after standard therapy.
The main questions it aims to answer are:
- how safe and tolerable is BI-1910
- what is maximum tolerated or administrated dose
- to determine recommended dose for further clinical trials
Participants will receive infusions of BI-1910 alone or combination with pembrolizumab every 3 weeks.
Detailed description
This is a Phase 1/2a, open-label, dose-escalation, multicenter, FIH, consecutive-cohort, clinical trial of BI-1910, as a single agent and in combination with pembrolizumab, in subjects with advanced/metastatic solid tumors whose disease has progressed after standard therapy.
The trial comprises 2 phases: a Phase 1 with Parts A and B, and a Phase 2a with Parts A and B.
Phase 1 Part A consists of a dose escalation of BI-1910 as a single agent to evaluate safety and tolerability and to determine the RP2D as a single agent (sRP2D) in subjects with advanced/metastatic solid tumors whose disease has progressed after standard therapy.
Phase 1 Part B consists of a dose escalation of BI-1910 in combination with pembrolizumab to evaluate the safety and tolerability of the combination treatment and to allow selection of the RP2D for BI-1910 in combination with pembrolizumab (cRP2D) in subjects with advanced/metastatic solid tumors whose disease has progressed after standard therapy.
Phase 2a will assess BI-1910 administered as a single agent (Part A) and in combination with pembrolizumab (Part B) at the respective hypothesized RP2D(s) determined in Phase 1. Phase 2a expansion will be conducted in indication specific cohorts of subjects. The aim of the Phase 2a is to urther assess the safety and tolerability of BI-1910 as a single agent (Part A) and in combination with pembrolizumab (Part B), characterize its PK and pharmacodynamics, and assess preliminary antitumor activity by ORR, DoR, and progression-free survival (PFS), as measured by RECIST v1.1 and iRECIST.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a Phase 1/2a, open-label, dose-escalation, multicenter, FIH, consecutive-cohort, clinical trial of BI-1910, as a single agent and in combination with pembrolizumab.
| Arm | Type | Receives |
|---|---|---|
| Phase I, Part A - Dose escalation and safety of BI-1910 as single agent | Experimental | Drug: BI-1910Dose escalation of BI-1910 administered as a single agent. |
| Phase I, Part B - Dose escalation and safety of BI-1910 in combination with pembrolizumab | Experimental | Drug: BI-1910, Drug: PembrolizumabDose escalation of BI-1910 in combination with pembrolizumab. |
| Phase 2a, Part A - Dose expansion of BI-1910 as single agent | Experimental | Drug: BI-1910BI-1910 administered as a single agent at the hypothesized recommended phase 2 dose determined in Phase 1. |
| Phase 2a, Part B - Dose expansion of BI-1910 | Experimental | Drug: BI-1910, Drug: PembrolizumabBI-1910 administered in combination with pembrolizumab at the respective hypothesized recommended phase 2 doses determined in Phase 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is willing and able to provide signed informed consent for the trial.
- Is ≥18 years of age on the day of signing the informed consent form.
- Has a histologically-confirmed advanced/metastatic solid tumor.
- Has received standard of care and progressed or is intolerant of, or is not eligible to receive standard of care antineoplastic therapy.
- Has at least 1 measurable disease lesion as defined by RECIST v1.1.
Key exclusion criteria (29 listed)
- Needs doses of prednisolone >10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has known or suspected hypersensitivity to BI-1910 or pembrolizumab.
- Has cardiac or renal amyloid light-chain amyloidosis.
- Has received the following:
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 |
|---|---|---|
| BI-1910BI-1910 administered as a flat-dose IV infusion once every 3 weeks | Drug | Phase 2a, Part A - Dose expansion of BI-1910 as single agent, Phase 2a, Part B - Dose expansion of BI-1910, Phase I, Part A - Dose escalation and safety of BI-1910 as single agent, Phase I, Part B - Dose escalation and safety of BI-1910 in combination with pembrolizumab |
| PembrolizumabPembrolizumab be administered as an IV infusion at its standard flat dose (200 mg) once every 3 weeks prior to the BI-1910 infusion | Drug | Phase 2a, Part B - Dose expansion of BI-1910, Phase I, Part B - Dose escalation and safety of BI-1910 in combination with pembrolizumab |
Primary outcome
Occurrence of adverse events (AEs)
Time frame: From the start of the study treatment for up to 2 years and 90 days.
AEs will be assessed by the investigators by severity and will be graded according to the NCI CTCAE v5.0 or higher and causality between AEs and the exposure to the study treatment.
Occurrence of serious adverse events (SAEs)
Time frame: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
SAEs will be assessed by the investigators by severity and will be graded according to the NCI CTCAE v5.0 or higher and causality between SAEs and the exposure to the study treatment
Frequency of AEs leading to discontinuation of study treatment
Time frame: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
All adverse events leading to premature study treatment discontinuation will be analyzed descriptively utilizing corresponding MedDRA, System Organ Classes, and Preferred Terms.
Frequency of dose interruptions and dose reductions.
Time frame: From the start of the study treatment for up to 2 years
Study treatment modifications will be summarized in 2 categories: dose reduction and dose interruptions. The number and percentage of subjects who have any dose reduction or interruption and have at least 1 dose reduction or interruption will be summarized. Lastly, the primary reason for each form of study treatment modification will also be summarized.
Changes from baseline in laboratory parameters
Time frame: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
These include clinical laboratory assessments (hematology, clinical chemistry, urinalysis), additional CRP assessment, coagulation, thyroid, pregnancy, and viral serology assessments Safety laboratory results will be graded by NCI CTCAE v5.0 (or higher). If no grading exists, values will be classified into low/normal/high based on laboratory normal ranges. Each parameter will be presented by descriptive statistics at each visit, including change from baseline.
Changes from baseline in temperature (C or F)
Time frame: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Temperature (C or F) will be measured in a seated or supine position after 5 minutes' rest and will be summarized by descriptive statistics at each visit, including change from baseline.
Changes from baseline in Respiratory Rate (Breaths/Min)
Time frame: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Respiratory rate (breaths/min) will be measured in a seated or supine position after 5 minutes' rest and will be summarized by descriptive statistics at each visit, including change from baseline.
Changes from baseline in Blood Pressure (mmHg)
Time frame: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Systolic and diastolic blood pressure (mmHg) will be measured in a seated or supine position after 5 minutes' rest and will be summarized by descriptive statistics at each visit, including change from baseline.
Changes from baseline in O2 Saturation (%)
Time frame: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
O2 Saturation (%) will be measured in a seated or supine position after 5 minutes' rest and will be summarized by descriptive statistics at each visit, including change from baseline.
Changes from baseline in weight
Time frame: From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Weight (kg or lb) and body surface area (m2) will be collected at Screening and on each dose day before any study treatment is administered and will be summarized by descriptive statistics at each visit, including change from baseline. Height (cm or in) will be recorded at baseline only
Occurrence of dose limiting toxicities (DLTs)
Time frame: During phase 1 Part A: from the first dose of BI-1910 for 21 days. During phase 1 part B: from the first dose of BI-1910 for 42 days.
All adverse events meeting the DLT criteria will be considered a DLT potentially related to the study treatment, regardless of Investigator/Sponsor causality assessment, excluding toxicities that are clearly related to disease progression or inter-current illness. DLTs will be considered by the safety monitoring committee for the purposes of dosing decisions.
identification of dose/dose range fulfilling favorable PK and pharmacodynamic profile, with acceptable safety
Time frame: During phase 2a from screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
based on the totality of the efficacy, safety, PK, and pharmacodynamic endpoints
7 secondary outcomes
Maximum Concentration (Cmax) of BI-1910
Time frame: From the start of the study treatment for up to 2 years and 90 days.
Serum concentration-time curve [AUC] of BI-1910
Time frame: From the start of the study treatment for up to 2 years and 90 days.
Terminal half-life (t½) of BI-1910
Time frame: From the start of the study treatment for up to 2 years and 90 days.
Recommended dose range (RDR)
Time frame: During phase 1 From screening for up to 28 days, throughout treatment for up to 2 years and through follow-up for up to 90 days
Incidence and titer of antidrug antibodies (ADAs).
Time frame: From the start of the study treatment for up to 2 years and 90 days.
Objective response rate (ORR).
Time frame: During phase 2a from from the start of the study treatment for up to 2 years and 30 days
Duration of response (DoR).
Time frame: During phase 2a from from the start of the study treatment for up to 2 years and 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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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.
Andres McAllister, PhD study director
BioInvent International AB
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BI-1910 and Pembrolizumab in people with Solid Tumors and Non Small Cell Lung Cancer, run by BioInvent International AB at 8 sites in 4 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 9 inclusion and 29 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: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Sweden, Denmark, Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Occurrence of adverse events (AEs) (time frame: From the start of the study treatment for up to 2 years and 90 days.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2025.