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

Part of paid clinical trials in Los Angeles, California.

Sponsor
BioInvent International AB
Study ID
NCT04219254
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BI1206 — DRUG
    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

Study Details

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

Key Dates

Start date
Jun 29, 2020
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
197 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BI-1206 + Pembrolizumab 25mg/mL (MK-3475)
    BI-1206 administrated either IV or SC + Pembrolizumab 200mg administered IV every third week as a fixed dose will be used.

Primary Outcome Measure

Documentation of AEs and SAEs, clinically significant laboratory parameters, and physical findings, as well as their causality to BI-1206 and/or pembrolizumab administration [ Time Frame: Up to 2 year ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California Los AngelesLos AngelesCalifornia90024
Alkassis, MD
Sarah Cannon Research InstituteDenverColorado80218-
HealthPartners Institute - Regions Cancer Care Center,Saint PaulMinnesota55101-
Oklahoma University , Stephenson Cancer CenterOklahoma CityOklahoma73104-
NEXT OncologySan AntonioTexas78229-

Find similar trials in Los Angeles, CA

By research site
University of California Los Angeles· Los Angeles, CASarah Cannon Research Institute· Denver, COHealthPartners Institute - Regions Cancer Care Center· Saint Paul, MNOklahoma University , Stephenson Cancer Center· Oklahoma City, OKNEXT Oncology· San Antonio, TX

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