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ACTIVE NOT RECRUITING
NCT06205706
PHASE1/PHASE2

BI-1910 as a Single Agent and in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors

Sponsor: BioInvent International AB

View on ClinicalTrials.gov

Summary

The goal of this first in human clinical trial is to test BI-1910 administered as single agent and in combination with pembrolizumab in subjects with advanced/metastatic solid tumors whose disease has progressed after standard therapy. The main questions it aims to answer are: * how safe and tolerable is BI-1910 * what is maximum tolerated or administrated dose * to determine recommended dose for further clinical trials Participants will receive infusions of BI-1910 alone or combination with pembrolizumab every 3 weeks.

Official title: Phase 1/2a Open-Label, Dose-Escalation, Multicenter, First-in-Human, Consecutive-Cohort, Clinical Trial of BI-1910, a Monoclonal Antibody to Tumor Necrosis Factor Receptor 2 (TNFR2), as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2023-12-04

Completion Date

2028-11-07

Last Updated

2025-09-19

Healthy Volunteers

No

Interventions

DRUG

BI-1910

BI-1910 administered as a flat-dose IV infusion once every 3 weeks

DRUG

Pembrolizumab

Pembrolizumab be administered as an IV infusion at its standard flat dose (200 mg) once every 3 weeks prior to the BI-1910 infusion

Locations (8)

Rigshospitalet

Copenhagen, Denmark

Universitätsklinikum Essen

Essen, Germany

Hospital HM Nou Delfos

Barcelona, Spain

HM Sanchinarro

Madrid, Spain

Hospital Fundacion Jimenez Diaz

Madrid, Spain

Hospital universitario Virgen del Rocio

Seville, Spain

Lund University Hospital

Lund, Sweden

Karolinska University Hospital, Solna

Stockholm, Sweden