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

NCT06205706 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Andres McAllister, PhD · BioInvent International AB

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2027-07-14
Completion
2028-11-07
FDA Drug
Yes

Countries

  • Denmark
  • Germany
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06205706 on ClinicalTrials.gov