A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated (NCT05327946)
An Open-label, Phase I Dose Escalation Followed by Dose Expansion Trial in Patients With Advanced Solid Tumours to Investigate Safety, Pharmacokinetics, and Efficacy and to Select the Dose for Further Development of BI 770371 in Combination With Ezabenlimab
🩺 Plain-English Summary (8th-Grade Level)
This study is open to adults with advanced cancer (solid tumours). People for whom previous treatment was not successful and for whom no other treatment options exist can join the study. The purpose of this study is to find the highest dose of BI 770371 that people with advanced cancer can tolerate when taken alone or together with a medicine called ezabenlimab. BI 770371 and ezabenlimab are antibodies that may help the immune system fight cancer (checkpoint inhibitors). In this study, BI 770371 is given to people for the first time. Participants get BI 770371 alone or together with ezabenlimab as an infusion every 3 weeks. It is planned that participants can stay in the study for up to 2 years, if they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. The doctors collect information on any health problems of the participants. The doctors also regularly monitor the size of the tumour.
Who can join: Review the eligibility criteria below.
Location: Florida Cancer Specialists-Sarasota-61670 — Sarasota, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- Florida Cancer Specialists-Sarasota-61670 — Sarasota, Florida
- John Theurer Cancer Center — Hackensack, New Jersey
- Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal, Quebec
- National Cancer Center Hospital East — Chiba, Kashiwa,
- National Cancer Center Hospital — Tokyo, Chuo-ku,
💰 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.
More studies in Solid Tumors
- Study of Pembrolizumab Following Surgery in Patients With Microsatellite Instability High (MSI-H) Solid Tumors — Basking Ridge, New Jersey
- Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours — Edmonton, Alberta
- Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) — Santa Monica, California
- A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial — Porto Alegre, Rio Grande do Sul
- Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors — Los Angeles, California
- Flavored, Oral Irinotecan VAL-413 (Orotecan®) Given With Temozolomide for Treatment of Recurrent Pediatric Solid Tumors — Phoenix, Arizona
Explore by condition: All Solid Tumors clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.