Colorectal Cancer Clinical Trial
Official title:
Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures
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.
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. ;
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