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New combo aims to reboot immunotherapy in resistant cancers

NCT ID NCT04219254

Disease control Sponsor: BioInvent International AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a new drug called BI-1206, given alongside the immunotherapy pembrolizumab, in adults with advanced solid tumors that have stopped responding to prior anti-PD-1/PD-L1 treatment. The study aims to find the safest dose and check for early signs of tumor shrinkage. About 197 participants will receive the combination intravenously or under the skin every three weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI-1206 (a monoclonal antibody) combined with pembrolizumab
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced solid tumors who have stopped responding to standard immunotherapy.
What could go wrong
This is an early-phase trial (phase 1/2a) with a small number of participants. The drug may not work or could cause serious side effects. It is not yet proven to be safe or effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 197 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2020

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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 Criteria: * 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 Additional exclusion criteria are described in the protocol.

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Conditions

The condition(s) this trial relates to.

neoplasm non-small cell lung carcinoma uveal melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumor, adult

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Centrul de Oncologie SF Nectarie SRL

    TERMINATED

    Craiova, Romania

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Spain

  • HealthPartners Institute - Regions Cancer Care Center,

    COMPLETED

    Saint Paul, Minnesota, 55101, United States

  • Hm Ciocc Málaga

    NOT_YET_RECRUITING

    Málaga, Spain

  • Hospital Puerta de Hierro

    RECRUITING

    Majadahonda, Spain

  • Hospital Universitari Dexeus

    RECRUITING

    Barcelona, Spain

  • Hospital Universitari Vall D´Hebron

    RECRUITING

    Barcelona, Spain

  • Hospital Virgen de la Macarena

    RECRUITING

    Seville, Spain

  • Institut Català d'Oncologia Hospital Duran i Reynals

    RECRUITING

    Barcelona, Spain

  • Institutul Oncologic "Prof. Dr. Ion Chiricuta"

    RECRUITING

    Cluj-Napoca, Romania

  • Instytut Centrum Zdrowia Matki Polki

    TERMINATED

    Lodz, Poland

  • Israel-Georgian Medical Research Clinic Helsicore

    TERMINATED

    Tbilisi, Georgia

  • Jerarsi Clinic

    RECRUITING

    Tbilisi, Georgia

  • Karolinska University Hospital, Solna

    RECRUITING

    Stockholm, Sweden

  • LTD High Technology Hospital Med Center

    RECRUITING

    Batumi, Georgia

  • Lund University Hospital

    RECRUITING

    Lund, Sweden

  • Maria Skłodowska-Curie National Institute of Oncology

    TERMINATED

    Gliwice, Poland

  • Medical University of Silesia

    RECRUITING

    Katowice, Poland

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, Germany

  • NEXT Oncology

    COMPLETED

    San Antonio, Texas, 78229, United States

  • Nationales Centrum für Tumorerkrankungen

    RECRUITING

    Heidelberg, Germany

  • Oklahoma University , Stephenson Cancer Center

    COMPLETED

    Oklahoma City, Oklahoma, 73104, United States

  • Sahlgrenska University Hospital

    COMPLETED

    Gothenburg, Sweden

  • Sarah Cannon Research Institute

    COMPLETED

    Denver, Colorado, 80218, United States

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90024, United States

  • Universität des Saarlandes

    RECRUITING

    Homburg, Germany

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