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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2025-10-28
Summary
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.
Conditions
Interventions
- DRUG
-
BI 770371
BI 770371
- DRUG
-
ezabenlimab
ezabenlimab
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-17
- Primary Completion
- 2024-07-16
- Completion
- 2026-09-30
- FDA Drug
- Yes
Countries
- United States
- Canada
- Japan
Study Locations
More Related Trials
-
A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors
NCT07147348 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
This Study Aims to Find and Test a Safe Dose of BI 905677 in Patients With Different Types of Cancer (Solid Tumours)
NCT03604445 ·Status: TERMINATED ·Phase: PHASE1
-
A Study of BI 3810944 in Patients With Advanced Cancer
NCT07224425 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Test Different Doses of BI 891065 Alone and in Combination With BI 754091 in Asian Patients With Different Types of Advanced Cancer (Solid Tumours)
NCT04138823 ·Status: COMPLETED ·Phase: PHASE1
-
Once or Twice Daily Administration of BIIB021 to Subjects With Advanced Solid Tumors
NCT00618735 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Evaluating OBI-902 in Participants With Advanced Solid Tumors
NCT07124117 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study to Find the Best Dose of BI 836880 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer
NCT03972150 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test Different Doses of BI 1831169 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors)
NCT05155332 ·Status: SUSPENDED ·Phase: PHASE1
-
Phase I of BIBW 2992/BIBF 1120 Combination Therapy in Solid Tumors
NCT00730821 ·Status: COMPLETED ·Phase: PHASE1
-
BI 6727 Administered Intravenously Every 3 Weeks in Patients With Solid Tumours
NCT02273388 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1/1b Dose Escalation Study Evaluating BSI-201 as a Single Agent and in Combination With Irinotecan in Subjects With Advanced Solid Tumors
NCT00298675 ·Status: COMPLETED ·Phase: PHASE1
-
This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors)
NCT03449381 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of BBI608 Administered With Paclitaxel in Adult Patients With Advanced Malignancies
NCT01325441 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of BI 853520 in Patients With Various Types of Advanced or Metastatic Cancer
NCT01335269 ·Status: COMPLETED ·Phase: PHASE1
-
Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours
NCT02145741 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
NCT03166631 ·Status: TERMINATED ·Phase: PHASE1
-
Phase I Study of BI 831266 in Patients With Advanced Solid Tumours
NCT00756223 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.
NCT00998296 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Find and Investigate a Safe Dose of a New Substance (BI 754091) for Patients With Solid Tumours
NCT02952248 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
NCT06750185 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Test How Well Different Doses of BI 3706674 Are Tolerated by People With Advanced Cancer in the Stomach and Oesophagus
NCT06056024 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Safety and Tolerability of BPT567 in Patients With Advanced Solid Tumors
NCT06779851 ·Status: TERMINATED ·Phase: PHASE1
-
Weekly BI 836880 in Patients With Advanced Solid Tumors
NCT02689505 ·Status: COMPLETED ·Phase: PHASE1
-
Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors
NCT07086768 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Dose Escalation Study of Oral Treatment With BIBW 2992 in Patients With Advanced Solid Tumors
NCT02171637 ·Status: COMPLETED ·Phase: PHASE1