A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors (NCT04219254)

🧪 Interventions in This Study

• BI1206 (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Is willing and able to provide written informed consent for the trial.
2. Is ≥18 years of age on day of signing informed consent.
3. Phase I only: Has a histologically confirmed advanced solid tumor. Subjects must have received at least 2 doses of an approved anti-PD-1/L1 mAb, and have documented progression on or within 12 weeks from the last dose of anti-PD-1/L1 mAb.
4. For patients with NSCLC (phase 2A SC cohorts): Have a histologically confirmed diagnosis of advanced or metastatic NSCLC and not have an EGFR sensitizing (activating) mutation or an ALK translocation. Have a PD-L1 positive (TPS≥50%) tumor as determined by IHC at a local laboratory. Have not received prior systemic immunotherapy or chemotherapy treatment for their advanced/metastatic NSCLC. Have provided formalin-fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of advanced or metastatic disease has been made and from a lesion not previously irradiated to perform biomarker analysis.
5. For patients with uveal melanoma (phase 2A SC cohort): Have a histologically confirmed diagnosis of advanced or metastatic uveal melanoma Have a PD-L1 positive (TPS≥1%) tumor as determined by IHC at a local laboratory. Have not received prior systemic immunotherapy or chemotherapy treatment for their advanced/metastatic uveal melanoma. Subjects who have received previous treatment with tebentafusp and/or liver directed therapy are allowed. Have provided formalin-fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of advanced or metastatic disease has been made and from a site not previously irradiated to perform biomarker analysis.
6. Phase I only: Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.
7. Has at least 1 measurable disease lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
8. Phase IIa only: Is willing to provide an archival tumor tissue sample or newly obtained \[core, incisional, OR excisional\] biopsy of a tumor lesion not previously irradiated.
9. Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1206.
10. Has a life expectancy of ≥12 weeks.
11. Has an ECOG performance status of 0-1.
12. Has adequate organ function as confirmed by laboratory values listed in the main body of the protocol

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (26 Sites)

Showing the first 25 of 26 sites.

• University of California Los Angeles — Los Angeles, California
• Sarah Cannon Research Institute — Denver, Colorado
• HealthPartners Institute - Regions Cancer Care Center, — Saint Paul, Minnesota
• Oklahoma University , Stephenson Cancer Center — Oklahoma City, Oklahoma
• NEXT Oncology — San Antonio, Texas
• LTD High Technology Hospital Med Center — Batumi,
• Israel-Georgian Medical Research Clinic Helsicore — Tbilisi,
• Jerarsi Clinic — Tbilisi,
• Medizinische Hochschule Hannover — Hanover,
• Nationales Centrum für Tumorerkrankungen — Heidelberg,
• Universität des Saarlandes — Homburg,
• Maria Skłodowska-Curie National Institute of Oncology — Gliwice,
• Medical University of Silesia — Katowice,
• Instytut Centrum Zdrowia Matki Polki — Lodz,
• Institutul Oncologic "Prof. Dr. Ion Chiricuta" — Cluj-Napoca,
• Centrul de Oncologie SF Nectarie SRL — Craiova,
• Hospital Universitari Dexeus — Barcelona,
• Hospital Universitari Vall D´Hebron — Barcelona,
• Institut Català d'Oncologia Hospital Duran i Reynals — Barcelona,
• Hospital Puerta de Hierro — Majadahonda,
• Hm Ciocc Málaga — Málaga,
• Clinica Universidad de Navarra — Pamplona,
• Hospital Virgen de la Macarena — Seville,
• Sahlgrenska University Hospital — Gothenburg,
• Lund University Hospital — Lund,

📞 Contact the Study Coordinator

Phone: +46735504521

Email: philipp.zimmermann@bioinvent.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: Starting at Week 10, these subjects will receive additional cycles of pembrolizumab and BI-1206 every 3 weeks for up to 32 additional cycles or up to 2 years from their first dose of BI-1206 therap...

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.