Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures

NCT06084689 | Withdrawn Phase 2 DMC

• 2 other identifiers: IB 2023-022023-506823-28-00
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Keywords

Tertiary lymphoid structures

Outcome Measures

Primary Outcomes (1)

• Disease control rate (DCR)

  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.

  6 months

Secondary Outcomes (5)

• Objective response rate

  6 months

• Duration of response (DoR)

  1 year

• Progression-free survival (PFS)

  1 year

• Overall survival

  1 year

• Safety and tolerability of the combination

  Throughout treatment period, an expected average of 6 months

Study Arms (2)

Cohort A: soft-tissue sarcomas

EXPERIMENTAL

Soft-tissue sarcomas

Drug: Ezabenlimab + BI907828

Cohort B: Solid tumors

EXPERIMENTAL

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

Drug: Ezabenlimab + BI907828

Interventions

Ezabenlimab + BI907828 DRUG

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

Cohort A: soft-tissue sarcomas; Cohort B: Solid tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis:
• For cohort A: soft-tissue sarcoma. As recommended by the French NCI, diagnosis must be reviewed or confirmed by the RRePS Network (Réseau de référence en pathologie des sarcomes et des viscères) as recommended by the French NCI (Institut National du Cancer, Inca).
• For cohort B: non-small cell lung cancer (NSCLC) or triple negative breast cancer (TNBC) or MMS colorectal cancer (MSS-CCR) or biliary tract cancer (BTC)
• Age ≥ 18 years,
• Advanced/unresectable and/or metastatic disease,
• Mature TLS positive status
• TP53-wild type status known (by molecular biology)
• Cohort B: are eligible the following populations
• NSCLC known PD-L1 tumor proportion score (TPS) \< 50% AND naïve from treatment with ICI (immune checkpoint inhibitors)
• NSCLC exposed to anti-PD1 or PD-L1 based therapy with clinical benefit (clinical benefit is defined as objective response or stable disease for at least 4 months)
• TNBC exposed to anti-PD1 or PD-L1 based therapy with clinical benefit (clinical benefit is defined as objective response or stable disease for at least 4 months)
• MSS-CCR naïve from treatment with ICI
• Biliary tract cancer exposed to anti-PD1 or PD-L1 based therapy with clinical benefit (clinical benefit is defined as objective response or stable disease for at least 4 months)
• Performance status 0-2
• Life expectancy ≥ 8 weeks,

You may not qualify if:

• Prior treatment with ezabenlimab and/or BI 907828,
• Women who are pregnant or breast feeding,
• Participation to a study involving a medical or therapeutic intervention in the last 30 days,
• Previous enrolment in the present study,
• Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons,
• Inability to swallow,
• History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins,
• Known hypersensitivity to Chinese hamster ovary cell products or to any component of the ezabenlimab or BI 907828 formulation,
• Symptomatic or actively progressing central nervous system (CNS) metastases.
• History of leptomeningeal disease,
• Primary CNS tumors with any of the following characteristics:
• History of intracranial hemorrhage or spinal cord hemorrhage
• Neurosurgical resection or brain biopsy to the primary brain tumor within 28 days of Cycle 1 Day 1
• Any systemic anticancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of ezabenlimab combined with BI 907828,
• Whole brain radiotherapy within 14 days prior to start of BI 754091 combined with BI 907828

Sponsors & Collaborators

• Institut Bergonié: lead
• Boehringer Ingelheim: collaborator

Study Sites (6)

Institut Bergonié

Bordeaux, 33076, France

Location

Centre Georges François Leclerc

Dijon, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Centre Léon Bérard

Lyon, France

Location

CHRU Poitiers

Poitiers, France

Location

Centre Eugène Marquis

Rennes, France

Location

MeSH Terms

Conditions

Sarcoma; Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms; Colorectal Neoplasms; Biliary Tract Neoplasms; Tertiary Lymphoid Structures

Interventions

brigimadlin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Biliary Tract Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine ITALIANO, MD, PhD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 single-arm phase II trials: * Cohort A: soft-tissue sarcomas * Cohort B: Solid tumors \[non-small cell lung cancer (NSCLC) or triple negative breast cancer (TNBC) or MMS colorectal cancer (MSS-CCR) or biliary tract cancer (BTC)\]

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: June 14, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

FR (6)