Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Triple Negative Breast Neoplasms

Sarcoma

Tertiary Lymphoid Structures

Biliary Tract Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Biliary Tract Diseases

Pathological Conditions, Anatomical

Biliary Tract Cancer

Soft Tissue Sarcoma

Solid tumors \[non-small cell lung cancer (NSCLC) or triple negative breast cancer (TNBC) or MMS colorectal cancer (MSS-CCR) or biliary tract cancer (BTC)\]

A treatment cycle consists of 3 weeks. Both treatments will be administered on Day 1 of each cycle.

Ezabenlimab + BI907828

Antoine ITALIANO, MD, PhD

Simone MATHOULIN PELISSIER, MD, PhD

Antoine Italiano, MD, PhD

François Ghiringhelli, MD, PhD

Loïc Lebellec, MD

Armelle Dufresne, MD

Xavier Choderlos de Laclos, MD

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.

2 single-arm phase II trials:

* Cohort A: soft-tissue sarcomas
* Cohort B: Solid tumors \[non-small cell lung cancer (NSCLC) or triple negative breast cancer (TNBC) or MMS colorectal cancer (MSS-CCR) or biliary tract cancer (BTC)\]

Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures

Disease control rate (DCR), defined as the proportion of patients with disease control lasting for at least 24 weeks since treatment onset, will be reported.

Objective response rate (ORR), defined as the proportion of patients with objective response will be assessed, based on centralized radiological review, within 24 weeks of treatment onset.

Duration of response (DoR) defined as the time from documentation of tumor response (CR, Cru, PR, PRu) to disease progression (as per RECIST V1.1).

Progression-free survival (PFS) defined as the time from the first day of treatment to the first documented disease progression (as per RECIST v1.1) or death (due to any cause), whichever occurs first.

Overall survival defined as the time from the first day of treatment to death (due to any cause).

Occurence of adverse events (AEs) and Serious adverse events (SAEs)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures	NCT06084689	Adult Soft Tiss... Non Small Cell ... Triple Negative... Colorectal Canc... Biliary Tract C...	Ezabenlimab + B...	18 Years -	Institut Bergonié
Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures	NCT06084689	Adult Soft Tiss... Non Small Cell ... Triple Negative... Colorectal Canc... Biliary Tract C...	Ezabenlimab + B...	18 Years -	Institut Bergonié

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