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Solid Tumor, AdultPhase 1/2NCT04219254

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

A Phase 1/2 study testing BI1206 in people with Solid Tumor, Adult, run by BioInvent International AB at 26 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, Adult
What is being tested?
BI1206
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
26 sitesin 7 countries
Study dates
29 Jun 2020to Nov 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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

Who cannot join

  • 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
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  • 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
  • Additional exclusion criteria are described in the protocol.

Trial locations and contacts

26 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Philipp Zimmermann, Dr. rer. nat. contact

+46735504521

philipp.zimmermann@bioinvent.com

Andres McAllister, PhD contact

andres.mcallister@bioinvent.com

26 sites in 7 countries

Spain7 sites, 7 recruiting

  • Hospital Universitari Dexeus

    Barcelona

    Gonzalez Cao, MD

    Recruiting

  • Hospital Universitari Vall D´Hebron

    Barcelona

    Muñoz Couselo, MD

    Recruiting

  • Institut Català d'Oncologia Hospital Duran i Reynals

    Barcelona

    Piulats, MD

    Recruiting

  • Hospital Puerta de Hierro

    Majadahonda

    Provencio, MD

    Recruiting

  • Hm Ciocc Málaga

    Málaga

    Medina, MD

    Not yet recruiting

  • Clinica Universidad de Navarra

    Pamplona

    Melero, MD

    Recruiting

  • Hospital Virgen de la Macarena

    Seville

    Manrique, MD

    Recruiting

Other trials in Spain

United States5 sites, 1 recruiting

  • Sarah Cannon Research Institute

    Denver, Colorado, 80218

    Completed

  • University of California Los Angeles

    Los Angeles, California, 90024

    Alkassis, MD

    Recruiting

  • Oklahoma University , Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

    Completed

  • HealthPartners Institute - Regions Cancer Care Center,

    Saint Paul, Minnesota, 55101

    Completed

  • NEXT Oncology

    San Antonio, Texas, 78229

    Completed

Other trials in United States

Georgia3 sites, 2 recruiting

  • LTD High Technology Hospital Med Center

    Batumi

    Makharadze, MD

    Recruiting

  • Israel-Georgian Medical Research Clinic Helsicore

    Tbilisi

    Terminated

  • Jerarsi Clinic

    Tbilisi

    Khupenia, MD

    Recruiting

Other trials in Georgia

Germany3 sites, 3 recruiting

  • Medizinische Hochschule Hannover

    Hanover

    Lennartz, MD

    Recruiting

  • Nationales Centrum für Tumorerkrankungen

    Heidelberg

    Hassel, MD

    Recruiting

  • Universität des Saarlandes

    Homburg

    Stratmann, MD

    Recruiting

Other trials in Germany

Poland3 sites, 1 recruiting

  • Maria Skłodowska-Curie National Institute of Oncology

    Gliwice

    Terminated

  • Medical University of Silesia

    Katowice

    Kabut, MD

    Recruiting

  • Instytut Centrum Zdrowia Matki Polki

    Lodz

    Terminated

Other trials in Poland

Sweden3 sites, 2 recruiting

  • Sahlgrenska University Hospital

    Gothenburg

    Completed

  • Lund University Hospital

    Lund

    Carneiro, PhD

    Recruiting

  • Karolinska University Hospital, Solna

    Stockholm

    Yachnin, PhD

    Recruiting

Other trials in Sweden

Romania2 sites, 1 recruiting

  • Institutul Oncologic "Prof. Dr. Ion Chiricuta"

    Cluj-Napoca

    Ciuleanu, MD

    Recruiting

  • Centrul de Oncologie SF Nectarie SRL

    Craiova

    Terminated

Other trials in Romania

About this study

Official title: 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

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

Read the 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.

Being tested
BI1206

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI1206Drug

    Also called Pembrolizumab 25mg/mL (MK-3475)

    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 groups in NCT04219254
Study groupRoleWhat they receive
BI-1206 + Pembrolizumab 25mg/mL (MK-3475)ExperimentalBI-1206 administrated either IV or SC + Pembrolizumab 200mg administered IV every third week as a fixed dose will be used.
Receives: Drug: BI1206

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 2 year

  2. 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

    Measured: During the 42-day treatment period on induction therapy

Secondary outcomes (3)

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

    Study the PK profile of BI-1206 administered IV or SC in combination with pembrolizumab in subjects with advanced solid tumors

    Measured: Up to 2 year

  2. Measurement of ADA response to BI-1206.

    Assess the immunogenicity of BI-1206, administered IV or SC, in subjects with advanced solid tumors, when given in combination with pembrolizumab.

    Measured: Up to 2 year

  3. Measurement of CD32b receptor occupancy on B cells.

    Evaluate the effect of BI-1206 IV or SC when administered in combination with pembrolizumab on CD32b receptor occupancy on B cells in subjects with advanced solid tumors.

    Measured: Up to 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2020
  2. Study start29 Jun 2020
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Phase 1/2a, dose escalation, consecutive-cohort, open-label study trial of BI-1206 in combination with pembrolizumab
Masking
None (open label)
Enrolment
197 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04219254
Sponsor's protocol ID
18-BI-1206-03
Status last verified
Jun 2026
First submitted
21 Oct 2019
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All information concerning the product as well as any matter concerning the operation of the Sponsor, such as clinical indications for the drug, its formula, methods of manufacture and other scientific data relating to it, that have been provided by the Sponsor and are unpublished, are confidential and must remain the sole property of the Sponsor. The Investigator will agree to use the information only for the purposes of carrying out this studytrial and for no other purpose unless prior written permission from the Sponsor is obtained.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BI1206 in people with Solid Tumor, Adult, run by BioInvent International AB at 26 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Spain, United States, Georgia, Germany, Poland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Philipp Zimmermann, Dr. rer. nat. (+46735504521, philipp.zimmermann@bioinvent.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04219254.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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