NCT06084689

Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Institut Bergonié · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adult Soft Tissue Sarcoma
• Non Small Cell Lung Cancer
• Triple Negative Breast Cancer
• Colorectal Cancer
• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Ezabenlimab + BI907828	A treatment cycle consists of 3 weeks. Both treatments will be administered on Day 1 of each cycle.

Timeline

• Start date: 2024-06-14
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2023-10-16
• Last updated: 2025-09-02

Locations

6 sites across 1 country: France