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Colorectal CancerPhase 1KISIMA-01NCT04046445

Phase 1b Study to Evaluate ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer

A Phase 1 study testing ATP128, BI 754091 and VSV-GP128 in people with Colorectal Cancer and MSS, run by Amal Therapeutics at 12 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a multi-center, non-randomised Phase 1b study to evaluate the safety and tolerability of ATP128 alone or in combination with BI 754091 and of heterologous prime-boost ATP128 + VSV-GP128 in combination with BI 754091. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer, MSS, Stage IV Colon Cancer
What is being tested?
ATP128, BI 754091 and VSV-GP128
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
12 sitesin 4 countries
Study dates
22 Jul 2019to 31 Aug 2025
Phase
Phase 1
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

  • Cohort 1a
  • Ability to comprehend and willingness to provide written informed consent (ICF) for the study.
  • Age ≥ 18 years.
  • Patient with histologically or cytologically confirmed stage IV CRC who has failed standard therapies.
  • Must have received Standard of Care systemic treatment consisting of fluoropyrimidin- oxaliplatin and/or irinotecan based therapy for stage IV CRC disease.
  • Presence of at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.1 as determined by the local site investigator/radiologist assessment.
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  • Presence of at least one liver lesion amenable to repeated biopsy, ideally not the one being used for measuring.
  • Willingness to undergo two fresh liver biopsies (pre-treatment and on-treatment).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • Life expectancy of at least 3 months.
  • Resolution of all toxicities and any toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). Patients with ≤ Grade 2 neuropathy and Grade ≤ 2 fatigue are an exception and may enroll.
  • Adequate renal, hepatic, and hematologic functions as defined by laboratory parameters ≤ 7 days before study treatment initiation.
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
  • Absolute lymphocyte count ≥ 0.5 × 109/L.
  • Platelets ≥ 100 × 109/L.
  • Hemoglobin level ≥ 9 g/dL.
  • Measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine clearance) ≥ 50 mL/min according to the formula of Cockcroft-Gault.
  • Total bilirubin ≤ 1.5 × upper limit of normal (ULN); if total bilirubin is > 1.5 x ULN then direct bilirubin must be ≤ 1.5 × ULN. Patients with known Gilbert's Syndrome may enroll if total bilirubin ≤ 3 × ULN.
  • Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 × ULN or ≤ 5 x ULN in patients with hepatic involvement.
  • A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to use highly effective contraceptive methods during the treatment period and for at least 180 days after the last dose of study treatment and refrain from egg donation during this period.
  • A male patient must agree to use a contraceptive during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.
  • Cohorts 1b, 2a, 2c, 3 and 4a:
  • Ability to comprehend and willingness to provide written informed consent (ICF) for the study.
  • Age ≥ 18 years.
  • Histologically or cytologically confirmed CRC and MSS/MMR proficient status confirmed by polymerase chain reaction (PCR)/ immunohistochemistry or next generation sequencing (NGS) assay at local institution.
  • Must have received a first line of SoC systemic therapy (physician choice) for stage IV disease and completed the therapy. They must have an ongoing partial response (PR) or a stable disease (SD) at the completion of this therapy, completion of therapy as defined by the investigator, however, with a minimum number of 4 months.
  • Note: Patient may have also received prior adjuvant therapy for stage II or III colorectal cancer, however the adjuvant treatment for stage II and III will not be considered as a prior line of therapy in case of relapse more than 6 months after the end of treatment.
  • Presence of at least 1 measurable lesion by computed tomography or magnetic resonance imaging per RECIST v1.1 as determined by the local site investigator/radiologist assessment.
  • Presence of at least one metastatic lesion amenable to paired biopsies (same lesion to be biopsied twice, at baseline and on D36), ideally not the one being used for measuring. However, liver lesions must be prioritized. Non-liver metastatic lesion biopsies may be collected only if the patient has no liver lesion or if the liver lesion is not amenable to paired biopsies (e.g. due to its size or location) or if the liver biopsy represents a risk or an undue inconvenience for the patient health/condition per Investigator judgment. In such cases, where a patient has no lesion amenable to biopsy at all, the paired biopsies may be waived by the Sponsor on a case-by-case basis.
  • Willingness to undergo two biopsies (liver lesion must be prioritized). If the Investigator judges the biopsies to be a risk or an undue inconvenience for the patient health/condition, they may be waived by the Sponsor on a case-by-case basis.
  • ECOG performance status 0 to 2.
  • Life expectancy of at least 6 months.
  • Has resolution of all toxicities and any toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). Patients with ≤ Grade 2 neuropathy and Grade ≤ 2 fatigue are an exception and may enroll.
  • Adequate renal, hepatic, thyroid and hematologic functions as defined by laboratory parameters ≤ 7 days before study treatment initiation.
  • Absolute neutrophil count ≥ 1.5 × 109/L.
  • Absolute lymphocyte count ≥ 0.5 × 109/L.
  • Platelets ≥ 100 × 109/L.
  • Hemoglobin level ≥ 9 g/dL.
  • Measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine clearance) ≥ 50 mL/min according to the formula of Cockcroft-Gault (see Appendix 6).
  • Total bilirubin ≤ 1.5 × ULN; if total bilirubin is > 1.5 x ULN then direct bilirubin must be ≤ 1.5 × ULN. Patients with known Gilbert's Syndrome may enroll if total bilirubin ≤ 3 × ULN.
  • ALT/AST ≤ 2.5 × ULN or ≤ 5 × ULN in patients with hepatic involvement.
  • A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to use highly effective contraceptive methods during the treatment period and for at least 180 days after the last dose of study treatment and refrain from egg donation during this period.
  • A male patient must agree to use a contraceptive during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.
  • Specific to Cohorts 3, 4a, 4b:
  • 1. Patient agrees to follow the instructions and precautions (see Section 4.4.1) related to potential VSV-GP128 shedding.
  • Cohorts 2b and 4b:
  • Ability to comprehend and willingness to provide written informed consent (ICF) for the study.
  • Age ≥ 18 years.
  • Histologically or cytologically confirmed CRC and MSS/MMR proficient status confirmed by PCR/immunohistochemistry or NGS assay at local institution.
  • Radiological evidence (CT/MRI) of liver-limited stage IV CRC.
  • Must have received first line neoadjuvant SoC systemic therapy (physician choice) for stage IV disease. May have received up to 16 weeks of this systemic SoC therapy.
  • Note: Patient may have also received prior adjuvant therapy for stage II or III colorectal cancer, however the adjuvant treatment for stage II and III will not be considered as a prior line of therapy in case of relapse more than 6 months after the end of treatment.
  • Absence of disease progression following neoadjuvant chemotherapy.
  • Eligible for R0 complete liver metastasectomy (in case the primary tumor was already removed) or for R0 complete simultaneous combined resection (resection of both liver metastases and primary tumor in case the primary tumor is still in place) with curative intent.
  • ECOG performance status 0 to 2.
  • Life expectancy of at least 12 months.
  • Adequate renal, hepatic, thyroid and hematologic functions as defined by laboratory parameters ≤ 7 days before study treatment initiation.
  • Absolute neutrophil count ≥ 1.5 × 109 /L.
  • Absolute lymphocyte count ≥ 0.5 × 109 /L.
  • Platelets ≥ 100 × 109/L.
  • Hemoglobin level ≥ 9 g/dL.
  • Measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine clearance) ≥ 50 mL/min according to the formula of Cockcroft-Gault (see Appendix 6).
  • Total bilirubin ≤ 1.5 × ULN; if total bilirubin is > 1.5 x ULN then direct bilirubin must be ≤ 1.5 × ULN. Patients with known Gilbert's Syndrome may enroll if total bilirubin ≤ 3 × ULN.
  • ALT/AST ≤ 2.5 × ULN or ≤ 5 × ULN in patients with hepatic involvement.
  • A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to use highly effective contraceptive methods during the treatment period and for at least 180 days after the last dose of study treatment and refrain from egg donation during this period.
  • A male patient must agree to use a contraceptive during the treatment period and for at least 180 days after the last dose of study treatment and refrain from donating sperm during this period.

Who cannot join

  • All Cohorts:
  • Unwilling or unable to follow protocol requirements or to give informed consent.
  • Gastro-intestinal bowel obstruction (partial or complete).
  • Participation in any other study with an investigational study drug or device requires Medical Monitor approval.
  • Prior monoclonal antibody within 4 weeks or 5 half-lives (whichever is shorter) before administration of study treatment with the exception of bevacizumab (Avastin®), cetuximab (Erbitux®) and panitumumab (Vectibix®) which may have been received within 15 days from initiation of study treatment. Supportive care (e.g. denosumab) may be used before and during study treatment.
  • Prior therapy with checkpoint inhibitors (anti-programmed death 1 (anti-PD-1), anti-programmed death-ligand 1 (anti-PD-L1), anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4)). Patients must not have received any investigational immunotherapy neither.
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  • Prior chemotherapy or targeted small molecule therapy within 15 days from initiation of study treatment.
  • Prior radiotherapy within 2 weeks of enrolment or within 4 weeks of enrolment in the case of radiation to central nervous system (CNS), which requires ≥ 4-week washout. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
  • Major (according the Investigator's judgment) surgery within 12 weeks before enrolment.
  • Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, ductal or lobular carcinoma in situ of the breast, or other non-invasive or indolent malignancy, or cancers from which the patient has been disease-free for > 1 year, after treatment with curative intent.
  • Immunosuppression including the continued use of systemic (at prednisone dose equivalent of > 10 mg) or topical steroids at or near the injection site (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents for any concurrent condition. All other corticosteroids must be discontinued > 4 weeks prior to first study treatment administration.
  • Previous vaccination (either therapeutic and/or prophylactic) against mCRC.
  • Pregnant/nursing women or unwilling to comply with acceptable contraceptive methods during study course.
  • History of autoimmune disease including any active autoimmune disease except vitiligo or childhood asthma.
  • Dermatological disease requiring local immunosuppressive agent.
  • Chronic or concurrent active infectious disease requiring systemic antibodies, antifungal, or antiviral treatment.
  • Known medical history of human immunodeficiency virus (HIV) infection or known medical history of acquired immunodeficiency syndrome (AIDS). HIV testing is not required unless mandated by the local health authority.
  • Has known history of or is positive for hepatitis B (hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (HCV RNA).
  • Note: Testing must be performed to determine eligibility. - Hepatitis B virus DNA must be undetectable and HBsAg negative at screening visit.- Hepatitis C antibody testing is allowed for screening purposes in countries where HCV RNA is not part of standard of care. In these cases, HCV antibody positive patients will be excluded.- Patients who have had definitive treatment for HCV are permitted if HCV RNA is undetectable at screening visit.
  • Known active CNS metastasis and/or carcinomatous meningitis.
  • Known cerebral oedema.
  • Live vaccine received within 30 days before initiation of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed. however, intranasal influenza vaccines (FluMist®) are live attenuated vaccines and are not allowed. COVID-19 vaccines that are not live vaccines are allowed before and during study treatment. However, a COVID-19 vaccination should not occur within ± 2 days of ATP128 study drug and ± 15 days of VSV-GP128 study drug.
  • History of allergy or hypersensitivity to any of the study drugs or study drug components.
  • Any condition in the judgment of the Investigator which makes the patient unsuitable for trial participation.
  • Cohorts 1b, 2a, 2b, 2c, 3, 4a and 4b:
  • Has received more than 1 line of therapy for stage IV disease (neoadjuvant therapy in Cohort 2b counts as 1 line).
  • History of pneumonitis within the last 5 years.
  • Active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids and/or whose pulse oximetry is less than 92% "on room air".
  • 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, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years old, or any concomitant medication known to prolong the QT interval (according to institutional guidelines).
  • Ejection fraction (EF) < 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 study treatment administration 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 the treating physician or both.
  • Specific to Cohorts 3, 4a, 4b:
  • Previous treatment with VSV-based agents.
  • Use of Tamoxifen within one month prior the initiation of study treatment.

Trial locations and contacts

12 sites in 4 countries.

12 sites in 4 countries

United States7 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Southern California

    Los Angeles, California, 90033

  • NYU Langone Health

    New York, New York, 10016

  • Weill Cornell Medicine

    New York, New York, 10065

  • Honor Health Institute

    Scottsdale, Arizona, 85258

Other trials in United States

Belgium2 sites

  • University Hospital Antwerpen

    Edegem, 2650

  • University Hospital Leuven

    Leuven, 3000

Other trials in Belgium

Switzerland2 sites

  • Geneva University Hospitals

    Geneva, 1205

  • University Hospital Zurich

    Zurich, Canton of Zurich, 8006

Other trials in Switzerland

Germany1 site

  • University Medicine Mainz

    Mainz, 55131

Other trials in Germany

About this study

Official title: An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer

This is a multi-center, non-randomised Phase 1b study to evaluate the safety and tolerability of ATP128 alone or in combination with BI 754091 and of heterologous prime-boost ATP128 + VSV-GP128 in combination with BI 754091.

ATP128 is a self-adjuvanted chimeric recombinant protein vaccine being developed in combination with programmed cell death 1 (PD-1) blockade for the treatment of microsatellite stable (MSS) patients not responding to PD-1 blockade. The PD-1 inhibitor being tested with ATP128 is the BI 754091 (Ezabenlimab) compound which belongs to the human immunoglobulin G4 (IgG4) subclass of antibodies.

Read more

VSV-GP is a recombinant chimeric vesicular stomatitis virus (VSV, Indiana strain Rhabdoviridae) which carries the envelope glycoprotein (GP) of the visceral non neurotropic WE-HPI strain of the Lymphocytic choriomeningitis virus (LCMV, Arenaviridae) instead of the native VSV glycoprotein (G) and is developed as integral part of the prime-boost regimen together with ATP128.

The Sponsor plans to enrol 96 patients with histologically or cytologically confirmed stage IV colorectal cancer coming form three different patient populations:

  • Cohort 1a: 6 patients with stage IV colorectal cancer (CRC) having failed standard of care (SoC) therapies
  • Cohorts 1b, 2a, 2c: 30 patients with stage IV microsatellite stable/mismatch repair-proficient (MSS/MMRp) CRC being in stable disease (SD) or partial response (PR) after first line of SoC (4-6 months duration at minimum)
  • Cohorts 2b, 4b: 30 patients with stage IV MSS/MMRp liver-limited disease

Patients eligible for this study will be enrolled in one of the 8 cohorts depending on their disease:

  • Patients in Cohort 1a will receive ATP128 as single agent
  • Patients in Cohorts 1b, 2a, 2b, 2c will receive ATP128 in combination with BI 754091
  • Patients in Cohorts 3, 4a, 4b will receive ATP128 and VSV-GP128 in combination with BI 754091
Being tested
ATP128, BI 754091, VSV-GP128
Keywords
CRC, Colorectal Cancer, MSS, Metastatic Colorectal Cancer, Liver Metastasis Colon Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer, KISIMA-01, ATP128, BI 754091 (Ezabenlimab), MMRp, VSV-GP128, Therapeutic viral vaccine, Heterologous prime-boost, Maintenance setting
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATP128Drug

    5-6 SC injections

  • BI 754091Drug

    Also called Ezabenlimab

    ≥ 7 IV infusions

  • VSV-GP128Drug

    1 single IV injection

Study groups in NCT04046445
Study groupRoleWhat they receive
Cohort 1aExperimental6 patients with stage IV CRC who failed SoC therapies
Receives: Drug: ATP128
Cohort 1bExperimental6 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC
Receives: Drug: ATP128; Drug: BI 754091
Cohort 2aExperimental5 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC
Receives: Drug: ATP128; Drug: BI 754091
Cohort 2bExperimental15 patients with stage IV MSS/MMRp CRC with liver-limited disease
Receives: Drug: ATP128; Drug: BI 754091
Cohort 2cExperimental19 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC
Receives: Drug: ATP128; Drug: BI 754091
Cohort 3Experimental6 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC
Receives: Drug: ATP128; Drug: BI 754091; Drug: VSV-GP128
Cohort 4aExperimental24 patients with stage IV MSS/MMRp CRC in SD or PR after first line of SoC
Receives: Drug: ATP128; Drug: BI 754091; Drug: VSV-GP128
Cohort 4bExperimental15 patients with stage IV MSS/MMRp CRC with liver-limited disease
Receives: Drug: ATP128; Drug: BI 754091; Drug: VSV-GP128

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate safety and tolerability by measure of incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Safety

    Measured: 1 year

  2. valuate anti-tumor effect of study treatment by measure of Progression-free survival (PFS)

    Based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 6 months

Secondary outcomes (6)

  1. Evaluate anti-tumor effect of study treatment by measure of Overall Response (OR)

    Based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 1 year

  2. Confirm recommended phase 2 dose (RP2D) of study treatment

    Based on evaluation of AEs with the support of pharmacodynamics

    Measured: 1 year

  3. Further evaluate anti-tumor effect of study treatment of Best Overall Response (BOR)

    Based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 1 year

  4. Evaluate anti-tumor effect of study treatment by measure of Duration of Response (DoR)

    Based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 1 year

  5. Evaluate anti-tumor effect of study treatment by measure of Progression Free Survival (PFS)

    Based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 1 year

  6. Evaluate anti-tumor effect of study treatment by measure of Relapse Free Survival (RFS)

    Based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2019
  2. Study start22 Jul 2019
  3. Primary completion31 May 2025 (estimated)
  4. Study completion31 Aug 2025 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
8 cohorts
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04046445
Sponsor's protocol ID
KISIMA-01
Other IDs
2019-000728-16, 2021DR1011, 2019
Acronym
KISIMA-01
Status last verified
Jan 2025
First submitted
30 Jul 2019
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Namdari H, Rezaei F, Heidarnejad F, Yaghoubzad-Maleki M, Karamigolbaghi M. Immunoinformatics Approach to Design a Chimeric CD70-Peptide Vaccine against Renal Cell Carcinoma. J Immunol Res. 2024 Jan 27;2024:2875635. doi: 10.1155/2024/2875635. eCollection 2024.

    PubMed 38314087

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ATP128, BI 754091 and VSV-GP128 in people with Colorectal Cancer and MSS, run by Amal Therapeutics at 12 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 69 inclusion and 36 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 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Belgium, Switzerland, 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 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.

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?

Evaluate safety and tolerability by measure of incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (time frame: 1 year). The study lists 2 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 NCT04046445, 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 29 Jan 2025.

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