Testing BI-1910 alone and with pembrolizumab for advanced solid tumors
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
This study is testing a new treatment called BI-1910, alone and with another drug called pembrolizumab, to see if it can help people with advanced solid tumors that haven't improved with standard treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | BioInvent International AB Industry-sponsored |
| Drugs / interventions | pembrolizumab, Chemotherapy, Immunotherapy, radiation |
| Locations | 12 sites (New Haven, Connecticut and 11 other locations) |
| Trial ID | NCT06205706 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and tolerability of BI-1910, both as a single agent and in combination with pembrolizumab, in patients with advanced or metastatic solid tumors that have progressed after standard therapies. The study is structured in two phases: Phase 1 focuses on dose escalation to determine the maximum tolerated dose and recommended dose for further trials, while Phase 2a assesses the safety, pharmacokinetics, and preliminary antitumor activity of the treatments at the determined doses. Participants will receive infusions every three weeks, and the trial includes multiple centers across different locations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically-confirmed advanced or metastatic solid tumors that have progressed after standard therapy.
Not a fit: Patients with known active central nervous system metastases or those requiring high doses of corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.
How similar studies have performed: Other studies have shown promise with similar immunotherapy combinations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Is willing and able to provide signed informed consent for the trial.
2. Is ≥18 years of age on the day of signing the informed consent form.
3. Has a histologically-confirmed advanced/metastatic solid tumor.
4. Has received standard of care and progressed or is intolerant of, or is not eligible to receive standard of care antineoplastic therapy.
5. Has at least 1 measurable disease lesion as defined by RECIST v1.1.
6. Must be willing to provide tumor biopsies as specified in the schedule of assessments
7. Has a life expectancy of ≥12 weeks.
8. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
9. Has adequate organ function as confirmed by laboratory values.
Exclusion Criteria:
1. Needs doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the trial other than as premedication.
2. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
3. Has known or suspected hypersensitivity to BI-1910 or pembrolizumab.
4. Has cardiac or renal amyloid light-chain amyloidosis.
5. Has received the following:
1. 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.
2. 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.
3. Immunotherapy within 4 weeks prior to the first dose of BI-1910.
6. 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).
7. Has had Grade ≥3 autoimmune manifestations of previous immune checkpoint inhibitor treatments (e.g., anti-PD-1, anti-PD-L1, or anti-CTLA-4).
8. Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis.
9. Has an active, known, or suspected autoimmune disease.
10. 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.
11. 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).
12. Has had major surgery from which the subject has not yet recovered.
13. 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.
14. Has presence of chronic graft versus host disease.
15. Has had an allogenic tissue/solid organ transplant.
16. Is positive for Human Immunodeficiency Virus (HIV).
17. Has history of chronic HBV or HCV infections.
18. Has a history of active tuberculosis (Bacillus tuberculosis).
19. Has received a live vaccine within 30 days before the first dose of study treatment.
20. Has uncontrolled or significant cardiovascular disease.
21. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the trial.
22. 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.
23. 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.
24. 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.
25. 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.
Where this trial is running
New Haven, Connecticut and 11 other locations
- Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Charité Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- Universitätsklinikum Essen — Essen, Germany (Not_yet_recruiting)
- Uniwersytecki Szpital Kliniczny — Poznań, Poland (Recruiting)
- Instytut Centrum Zdrowia Matki Polki — Łódź, Poland (Recruiting)
- Hospital HM Nou Delfos — Barcelona, Spain (Recruiting)
- HM Sanchinarro — Madrid, Spain (Recruiting)
- Hospital Fundacion Jimenez Diaz — Madrid, Spain (Recruiting)
- Hospital universitario Virgen del Rocio — Sevilla, Spain (Recruiting)
- Lund University Hospital — Lund, Sweden (Not_yet_recruiting)
- Karolinska University Hospital, Solna — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Mindaugas Meller
- Email: mindaugas.meller@bioinvent.com
- Phone: +370 666 75255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.