Trials Sponsors Conditions Drugs Pricing

Conditions

Adult patients with locally advanced/metastatic solid tumors Adult Soft Tissue Sarcoma Biliary Tract Cancer Colorectal Cancer Non Small Cell Lung Cancer Triple Negative Breast 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

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 + BI907828Drug

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

Cohort A: soft-tissue sarcomasCohort B: Solid tumors

BI 907828Type not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Ezabenlimab
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Ezabenlimab
Named ingredient: Ezabenlimab
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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).

Sponsors & Collaborators

Study Sites (6)

Institut Bergonié

Bordeaux, 33076, France

Centre Georges François Leclerc

Dijon, France

Centre Oscar Lambret

Lille, 59000, France

Centre Léon Bérard

Lyon, France

CHRU Poitiers

Poitiers, France

Centre Eugène Marquis

Rennes, France

MeSH Terms

Conditions

SarcomaCarcinoma, Non-Small-Cell LungTriple Negative Breast NeoplasmsColorectal NeoplasmsBiliary Tract NeoplasmsTertiary Lymphoid Structures

Interventions

brigimadlin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract Neoplasms

Study Officials

Antoine ITALIANO, MD, PhD
Institut Bergonié
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 16, 2023

Study Start

June 14, 2024

Study Stopped

Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Cohort A: soft-tissue sarcomas

Cohort B: Solid tumors

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Cohort A: soft-tissue sarcomas

Cohort B: Solid tumors

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source records

Locations