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BI-1206 with Pembrolizumab for Advanced Solid Tumors

This study is testing a new combination of two drugs, BI-1206 and pembrolizumab, for adults with advanced solid tumors. Pembrolizumab is an immunotherapy (a treatment that uses your body's own immune system to fight cancer). BI-1206 is a monoclonal antibody (a type of protein made in a lab that can attach to specific targets in the body). The study is looking at how safe this combination is and how well it works. To join, you must have an advanced solid tumor and have already received at least two doses of a similar immunotherapy drug (anti-PD-1/L1 mAb) and your cancer has progressed. The study is currently enrolling participants for the Phase 2a part.

Study design
This is a Phase 1/2a, multicenter, open-label study. It is designed to find the right dose of BI-1206 and then see how well it works in combination with pembrolizumab.
What's involved
You would receive BI-1206 and pembrolizumab, either intravenously (IV, into a vein) or subcutaneously (SC, under the skin), every three weeks. If you benefit, you could continue treatment for up to two years.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for up to two years. Dose-limiting toxicities will be assessed during the first 42 days of induction therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04219254

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
BioInvent International AB
~197 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:BI1206

At a glance

Recruiting sites
16 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Documentation of AEs and SAEs, clinically significant laboratory parameters, and physical findings, as well as their causality to BI-1206 and/or pembrolizumab administration
Measured over Up to 2 year
+1 more outcome measured

Conditions

Solid Tumor, Adult

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Where it's being run

26 sites across 11 states
Spain7
Georgia3
Germany3
Poland3
Sweden3
Romania2
California1
Colorado1

Who to contact

Philipp Zimmermann, Dr. rer. nat.
[email protected]
+46735504521
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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):
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.
Is able to safely undergo a baseline tumor tissue biopsy prior to first dose of BI-1206.
Has a life expectancy of ≥12 weeks.
Has an ECOG performance status of 0-1.
Has adequate organ function as confirmed by laboratory values listed in the main body of the protocol
Phase IIa only: Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrolment
Phase IIa only: Participants with history of HCV infection are eligible if HCV viral load is undetectable at Screening
Phase IIa only: Has adequate hematological and biochemical indices as listed in the main body of the protocol

Exclusion

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
Has uncontrolled or significant cardiovascular disease as listed in the main body of the protocol
Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or lead to participation not being in the best interest of the subject, in the opinion of the treating Investigator.
Is participating or planning to participate in another interventional clinical study or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study drug
Has a known additional malignancy of another type, with the exception of adequately treated cone-biopsied carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) and basal or squamous cell carcinoma of the skin
Has a diagnosis of primary or acquired immunodeficiency disorder or has taken any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
Is unable to attend the study site to receive the study treatment

What this trial measures

  • Documentation of AEs and SAEs, clinically significant laboratory parameters, and physical findings, as well as their causality to BI-1206 and/or pembrolizumab administrationUp to 2 year

    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

  • DLT occurrence; determination of signal-seeking dose, the MTD or maximum administered dose of BI-1206 in Phase 1, based on the mTPI-2 designDuring the 42-day treatment period on induction therapy

    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