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Clinical Trial Summary

Phase II, multicenter, open-label, multi-cohort proof-of-concept study designed to evaluate the safety and efficacy of Ezabenlimab combined with BI 907828 in patients with unresectable, locally advanced or metastatic solid tumors.


Clinical Trial Description

This study is a phase II, multicenter, open-label, multi-cohort proof-of-concept study designed to evaluate the safety and efficacy of Ezabenlimab combined with BI 907828 in patients with unresectable, locally advanced or metastatic solid tumors. Inclusions will proceed independently for 2 cohorts of patients with TP53 wild-type and TLS+ tumors (TLS: tertiary lymphoid strucutres), as follows: - Cohort A: soft-tissue sarcomas - Single-arm phase II trial - 2-stage optimal Simon's design (Simon, 1989) - Primary endpoint: is Disease Control Rate (DCR) within 24 weeks of treatment onset, as per RECIST v1.1. - Cohort B: Solid tumors [non-small cell lung cancer (NSCLC) or triple negative breast cancer (TNBC) or MMS colorectal cancer (MSS-CCR) or biliary tract cancer (BTC)] - Single-arm phase II trial - 2-stage optimal Simon's design (Simon, 1989) - Primary endpoint: is Disease Control Rate (DCR) within 24 weeks of treatment onset, as per RECIST v1.1. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06084689
Study type Interventional
Source Institut Bergonié
Contact Antoine ITALIANO, MD, PhD
Phone +33556333333
Email a.italiano@bordeaux.unicancer.fr
Status Not yet recruiting
Phase Phase 2
Start date January 1, 2024
Completion date January 1, 2027

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