NCT04219254

A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

A Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 197 (estimated)
• Sponsor: BioInvent International AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Detailed description

This is a Phase 1/2a, multicenter, dose-finding, consecutive-cohort, open-label trial of BI-1206 in combination with pembrolizumab in subjects with advanced solid tumors. The trial will consist of 2 main parts: Phase 1 with 2 different sets of cohorts assessing IV or SC dosing, with dose escalation of BI-1206 and selection of the RP2D of IV dosing (ivRP2D) and the RP2D of SC dosing (scRP2D). Phase 2a with 2 parts: a signal seeking and a dose optimization part. In the signal seeking part, subjects with uveal melanoma and Non-Small Cellular Lung Cancer (NSCLC) will be treated with Pembrolizumab intravenously and BI-1206 at the scRP2D subcutaneously. In the dose optimization part, subjects with NSCLC will be randomized into one of 3 expansion arms and treated with pembrolizumab and BI-1206 at the scRP2D. Subjects will initially receive 3 cycles of therapy with pembrolizumab in combination with BI-1206, either IV or SC. Subjects who show clinical benefit (CR, PR, or SD) at the Week 9 Visit may continue on combination therapy (pembrolizumab/BI-1206). Starting at Week 10, these subjects will receive additional cycles of pembrolizumab and BI-1206 every 3 weeks for up to 32 additional cycles or up to 2 years from their first dose of BI-1206 therapy or until progression. Note: The study is only open for enrolling subjects into the phase 2a part.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	BI1206	BI-1206 administrated either IV or SC every third week. Pembrolizumab 200mg administered IV every third week as a fixed dose will be used in Phase 1 and IIa. The mTPI2 Design will be used for both the IV and SC cohorts. ivRP2D and scRP2D to be used in Phase

Timeline

• Start date: 2020-06-29
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2020-01-07
• Last updated: 2026-04-15

Locations

25 sites across 7 countries: United States, Georgia, Germany, Poland, Romania, Spain, Sweden

Regulatory

• FDA-regulated drug study