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

NCT04219254 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 18-BI-1206-03
• Study Type: interventional
• Target: 197
• Locations: 7 countries
• Sites: 25

Brief 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

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (2)

• Documentation of AEs and SAEs, clinically significant laboratory parameters, and physical findings, as well as their causality to BI-1206 and/or pembrolizumab administration

  Assess the safety and tolerability profile of increasing doses of BI-1206, administered IV or SC, in combination with pembrolizumab in subjects with advanced solid tumors

  Up to 2 year

• DLT occurrence; determination of signal-seeking dose, the MTD or maximum administered dose of BI-1206 in Phase 1, based on the mTPI-2 design

  In Phase 1, identify DLTs, determine the MTD, and select a signal-seeking Phase 2a dose of BI-1206 given via IV infusion or SC injection in combination with pembrolizumab (administered at the standard dose of 200 mg every 3 weeks) to subjects with advanced solid tumors who are experiencing disease progression and have been previously treated with anti-PD-1 or anti- PD-L1 antibodies

  During the 42-day treatment period on induction therapy

Secondary Outcomes (3)

• Determination of standard PK parameters (i.e., AUC, Cmax, Tmax, and terminal half-life [t½]) for BI-1206

  Up to 2 year

• Measurement of ADA response to BI-1206.

  Up to 2 year

• Measurement of CD32b receptor occupancy on B cells.

  Up to 2 year

Other Outcomes (8)

• Assessment of best disease responses according to Immunological Response Evaluation Criteria in Solid Tumors (iRECIST).

  8 weeks after first dose BI1206 and every 9 weeks for subjects who continue on therapy

• Measurement of progression free survival.

  Up to 2 year

• Measurement of duration of objective response and objective response rate

  Up to 2 year

Study Arms (1)

BI-1206 + Pembrolizumab 25mg/mL (MK-3475)

EXPERIMENTAL

BI-1206 administrated either IV or SC + Pembrolizumab 200mg administered IV every third week as a fixed dose will be used.

Drug: BI1206

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

Also known as: Pembrolizumab 25mg/mL (MK-3475)

BI-1206 + Pembrolizumab 25mg/mL (MK-3475)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is willing and able to provide written informed consent for the trial.
• Is ≥18 years of age on day of signing informed consent.
• Phase I only: Has a histologically confirmed advanced solid tumor. Subjects must have received at least 2 doses of an approved anti-PD-1/L1 mAb, and have documented progression on or within 12 weeks from the last dose of anti-PD-1/L1 mAb.
• For patients with NSCLC (phase 2A SC cohorts):
• Have a histologically confirmed diagnosis of advanced or metastatic NSCLC and not have an EGFR sensitizing (activating) mutation or an ALK translocation.
• Have a PD-L1 positive (TPS≥50%) tumor as determined by IHC at a local laboratory.
• Have not received prior systemic immunotherapy or chemotherapy treatment for their advanced/metastatic NSCLC.
• Have provided formalin-fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of advanced or metastatic disease has been made and from a lesion not previously irradiated to perform biomarker analysis.
• For patients with uveal melanoma (phase 2A SC cohort): Have a histologically confirmed diagnosis of advanced or metastatic uveal melanoma
• Have a PD-L1 positive (TPS≥1%) tumor as determined by IHC at a local laboratory.
• Have not received prior systemic immunotherapy or chemotherapy treatment for their advanced/metastatic uveal melanoma. Subjects who have received previous treatment with tebentafusp and/or liver directed therapy are allowed.
• Have provided formalin-fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of advanced or metastatic disease has been made and from a site not previously irradiated to perform biomarker analysis.
• Phase I only: Is intolerant of, refuses, or is not eligible for standard antineoplastic therapy.
• Has at least 1 measurable disease lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
• Phase IIa only: Is willing to provide an archival tumor tissue sample or newly obtained \[core, incisional, OR excisional\] biopsy of a tumor lesion not previously irradiated.

You may not qualify if:

• Needs doses of prednisolone \>10 mg daily (or equipotent doses of other corticosteroids) while on the study, other than as premedication.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has known or suspected hypersensitivity to pembrolizumab or BI-1206 or any of their excipients.
• Has cardiac or renal amyloid light-chain (AL) amyloidosis.
• Has received radiotherapy within 2 weeks of the first dose of BI-1206.
• Has not recovered from AEs to at least Grade 1 by CTCAE v5.0 (or higher) due to prior anticancer therapies• Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
• Has an active, known or suspected autoimmune disease.
• Is a female subject and has the ability to become pregnant (or already pregnant or lactating/breastfeeding)
• Is a male subject with partner(s) of childbearing potential (unless he agrees to use a barrier method of contraception during the study and for 12 months after completing treatment)
• Has had major surgery from which the subject has not yet recovered Is at high medical risk because of non-malignant systemic disease, including severe active infections on treatment with antibiotics, antifungals, or antivirals
• Has presence of chronic graft-versus-host disease.
• Has had an allogenic tissue/solid organ transplant.
• Has a known history of HIV infection
• Has a history of active tuberculosis (Bacillus tuberculosis)
• Has received a live vaccine within 30 days before the first dose of study treatment

Sponsors & Collaborators

• BioInvent International AB: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (25)

University of California Los Angeles

Los Angeles, California, 90024, United States

NOT YET RECRUITING

Sarah Cannon Research Institute

Denver, Colorado, 80218, United States

COMPLETED

HealthPartners Institute - Regions Cancer Care Center,

Saint Paul, Minnesota, 55101, United States

COMPLETED

Oklahoma University , Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

COMPLETED

NEXT Oncology

San Antonio, Texas, 78229, United States

COMPLETED

LTD High Technology Hospital Med Center

Batumi, Georgia

RECRUITING

Israel-Georgian Medical Research Clinic Helsicore

Tbilisi, Georgia

TERMINATED

Jerarsi Clinic

Tbilisi, Georgia

RECRUITING

Medizinische Hochschule Hannover

Hanover, Germany

NOT YET RECRUITING

Nationales Centrum für Tumorerkrankungen

Heidelberg, Germany

NOT YET RECRUITING

Universität des Saarlandes

Homburg, Germany

NOT YET RECRUITING

Maria Skłodowska-Curie National Institute of Oncology

Gliwice, Poland

TERMINATED

Medical University of Silesia

Katowice, Poland

NOT YET RECRUITING

Instytut Centrum Zdrowia Matki Polki

Lodz, Poland

RECRUITING

Institutul Oncologic "Prof. Dr. Ion Chiricuta"

Cluj-Napoca, Romania

RECRUITING

Centrul de Oncologie SF Nectarie SRL

Craiova, Romania

RECRUITING

Hospital Universitari Dexeus

Barcelona, Spain

RECRUITING

Hospital Universitari Vall D´Hebron

Barcelona, Spain

RECRUITING

Institut Català d'Oncologia Hospital Duran i Reynals

Barcelona, Spain

RECRUITING

Hospital Puerta de Hierro

Majadahonda, Spain

NOT YET RECRUITING

Clinica Universidad de Navarra

Pamplona, Spain

RECRUITING

Hospital Virgen de la Macarena

Seville, Spain

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

COMPLETED

Lund University Hospital

Lund, Sweden

RECRUITING

Karolinska University Hospital, Solna

Stockholm, Sweden

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Central Study Contacts

Philipp Zimmermann, Dr. rer. nat.

CONTACT

+46735504521; philipp.zimmermann@bioinvent.com

Andres McAllister, PhD

CONTACT

andres.mcallister@bioinvent.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1/2a, dose escalation, consecutive-cohort, open-label study trial of BI-1206 in combination with pembrolizumab

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: January 7, 2020
• Study Start: June 29, 2020
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within one year from end of study
• Access Criteria: Paper copy of CSR

Locations

ES (6); SE (3); RO (2); GE (3); US (5); DE (3); PL (3)