Actively Recruiting
A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Led by BioInvent International AB · Updated on 2026-04-15
197
Participants Needed
25
Research Sites
383 weeks
Total Duration
On this page
Sponsors
B
BioInvent International AB
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
CONDITIONS
Official Title
A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent for the trial
- 18 years of age or older on the day of signing informed consent
- Phase 1 only: Histologically confirmed advanced solid tumor with documented progression after at least 2 doses of approved anti-PD-1/L1 monoclonal antibody
- Phase 2a NSCLC patients: Histologically confirmed advanced or metastatic NSCLC without EGFR activating mutation or ALK translocation, PD-L1 positive tumor (TPS 60;50%), no prior systemic immunotherapy or chemotherapy for advanced/metastatic disease, and provided tumor biopsy for biomarker analysis
- Phase 2a uveal melanoma patients: Histologically confirmed advanced or metastatic uveal melanoma, PD-L1 positive tumor (TPS 60;1%), no prior systemic immunotherapy or chemotherapy for advanced/metastatic disease except previous tebentafusp and/or liver directed therapy, and provided tumor biopsy for biomarker analysis
- Phase 1 only: Intolerant of, refuses, or not eligible for standard antineoplastic therapy
- At least 1 measurable disease lesion per RECIST v1.1
- Phase 2a only: Willing to provide archival tumor tissue or newly obtained biopsy from non-irradiated lesion
- Able to safely undergo baseline tumor tissue biopsy prior to first BI-1206 dose
- Life expectancy of at least 12 weeks
- ECOG performance status of 0 or 1
- Adequate organ function as confirmed by laboratory values
- Phase 2a only: For HBsAg positive participants, received HBV antiviral therapy for at least 4 weeks with undetectable HBV viral load prior to enrollment
- Phase 2a only: Participants with history of HCV infection eligible if HCV viral load is undetectable at screening
- Phase 2a only: Adequate hematological and biochemical indices as listed in protocol
You will not qualify if you...
- Requires doses of prednisolone greater than 10 mg daily or equivalent corticosteroids, except as premedication
- Known active central nervous system metastases or carcinomatous meningitis
- Known or suspected hypersensitivity to pembrolizumab, BI-1206, or their excipients
- Cardiac or renal amyloid light-chain amyloidosis
- Received radiotherapy within 2 weeks before first BI-1206 dose
- Has not recovered from adverse events to at least Grade 1 from prior anticancer therapies
- History of non-infectious pneumonitis requiring steroids or current pneumonitis
- Active, known or suspected autoimmune disease
- Female who is pregnant, breastfeeding, or capable of becoming pregnant
- Male with partners of childbearing potential who do not agree to use barrier contraception during study and for 12 months after treatment
- Recent major surgery not yet recovered from
- High medical risk due to non-malignant systemic disease including severe active infections on treatment
- Presence of chronic graft-versus-host disease
- History of allogenic tissue or solid organ transplant
- Known HIV infection
- History of active tuberculosis
- Received live vaccine within 30 days before first study treatment
- Uncontrolled or significant cardiovascular disease
- Known psychiatric or substance abuse disorder interfering with study participation
- Any condition, therapy, or laboratory abnormality that may interfere with study participation or safety as determined by investigator
- Participation in another interventional clinical study or investigational agent/device use within 4 weeks prior to first dose
- Known additional malignancy except adequately treated carcinoma in situ or certain skin cancers
- Diagnosis of primary or acquired immunodeficiency or recent immunosuppressive therapy within 7 days prior to first dose
- Unable to attend study site to receive treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
University of California Los Angeles
Los Angeles, California, United States, 90024
Not Yet Recruiting
2
Sarah Cannon Research Institute
Denver, Colorado, United States, 80218
Completed
3
HealthPartners Institute - Regions Cancer Care Center,
Saint Paul, Minnesota, United States, 55101
Completed
4
Oklahoma University , Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Completed
5
NEXT Oncology
San Antonio, Texas, United States, 78229
Completed
6
LTD High Technology Hospital Med Center
Batumi, Georgia
Actively Recruiting
7
Israel-Georgian Medical Research Clinic Helsicore
Tbilisi, Georgia
Terminated
8
Jerarsi Clinic
Tbilisi, Georgia
Actively Recruiting
9
Medizinische Hochschule Hannover
Hanover, Germany
Not Yet Recruiting
10
Nationales Centrum für Tumorerkrankungen
Heidelberg, Germany
Not Yet Recruiting
11
Universität des Saarlandes
Homburg, Germany
Not Yet Recruiting
12
Maria Skłodowska-Curie National Institute of Oncology
Gliwice, Poland
Terminated
13
Medical University of Silesia
Katowice, Poland
Not Yet Recruiting
14
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland
Actively Recruiting
15
Institutul Oncologic "Prof. Dr. Ion Chiricuta"
Cluj-Napoca, Romania
Actively Recruiting
16
Centrul de Oncologie SF Nectarie SRL
Craiova, Romania
Actively Recruiting
17
Hospital Universitari Dexeus
Barcelona, Spain
Actively Recruiting
18
Hospital Universitari Vall D´Hebron
Barcelona, Spain
Actively Recruiting
19
Institut Català d'Oncologia Hospital Duran i Reynals
Barcelona, Spain
Actively Recruiting
20
Hospital Puerta de Hierro
Majadahonda, Spain
Not Yet Recruiting
21
Clinica Universidad de Navarra
Pamplona, Spain
Actively Recruiting
22
Hospital Virgen de la Macarena
Seville, Spain
Actively Recruiting
23
Sahlgrenska University Hospital
Gothenburg, Sweden
Completed
24
Lund University Hospital
Lund, Sweden
Actively Recruiting
25
Karolinska University Hospital, Solna
Stockholm, Sweden
Actively Recruiting
Research Team
P
Philipp Zimmermann, Dr. rer. nat.
CONTACT
A
Andres McAllister, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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