Spots Global Cancer Trial Database for Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures

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Trial Identification

Brief Title: Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures

Official Title: Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures

Study ID: NCT06084689

Conditions

Adult Soft Tissue Sarcoma

Non Small Cell Lung Cancer

Triple Negative Breast Cancer

Colorectal Cancer

Biliary Tract Cancer

Interventions

Ezabenlimab + BI907828

Study Description

Brief 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.

Detailed 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.