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New antibody combo shows promise in early cancer trial

NCT ID NCT04752826

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This early-phase trial is testing an experimental drug called BI-1808, alone or with the immunotherapy pembrolizumab (Keytruda), in people with advanced cancers like ovarian cancer, T-cell lymphoma, and melanoma. The main goals are to check safety, find the best dose, and see how the body handles the drug. About 176 participants whose cancer has worsened after standard treatments will receive infusions 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-1808 (an experimental antibody) and pembrolizumab (Keytruda, an immunotherapy drug)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced cancers that have stopped responding to standard therapies.
What could go wrong
This is an early, first-in-human trial with a small number of participants, so safety and effectiveness are not yet proven. There is a risk of side effects, and the drug may not work as hoped.

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 250 people

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

Started

Jan 2021

Expected to finish

Dec 2028

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: * Able and willing to provide written informed consent. * Aged 18 years or older. * Histologically confirmed advanced or metastatic malignancy eligible for an enrolling study cohort. * Disease progression following, intolerance of, ineligibility for, or refusal of applicable standard therapy. * At least one measurable lesion according to the response criteria specified in the protocol. * Eastern Cooperative Oncology Group performance status of 0 or 1. * Life expectancy of at least 12 weeks. * Adequate organ function. * Willing and medically suitable to provide required tumor or skin biopsies. * Meets the disease-specific and treatment-history requirements of the applicable Phase 2a cohort. * For Phase 2a Part C: Histologically confirmed platinum-resistant high-grade serous or clear-cell ovarian carcinoma, prior platinum-based treatment as specified in the protocol, and suitability for paclitaxel treatment. Exclusion Criteria: 1\. Active central nervous system metastases or carcinomatous meningitis. * Active or clinically significant autoimmune disease, immunodeficiency, or use of prohibited immunosuppressive treatment. * Prior treatment-related toxicity not recovered to the level specified in the protocol. * Prior anticancer therapy, radiotherapy, immunotherapy, investigational treatment, or live vaccine within the protocol-defined washout period. * History of clinically significant immune-mediated toxicity, including pneumonitis, associated with previous immune-checkpoint inhibitor treatment. * Uncontrolled or clinically significant cardiovascular disease, serious infection, or another condition that could compromise safety or study participation. * Major surgery without adequate recovery. * Prior allogeneic tissue or solid-organ transplantation or active graft-versus-host disease. * Pregnancy or breastfeeding, or unwillingness to comply with protocol-defined contraceptive requirements. * Known hypersensitivity to a study treatment or its components. * Another active malignancy, except for protocol-defined permitted malignancies. * Participation in another interventional clinical trial that conflicts with this study. * Unable or unlikely to comply with study procedures and requirements. * For Phase 2a Part C: Receipt of prohibited colony-stimulating factors within the protocol-defined period before treatment.

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Conditions

The condition(s) this trial relates to.

cancer fallopian tube cancer melanoma neoplasm ovarian cancer ovarian clear cell cancer ovarian serous adenocarcinoma peritoneum cancer T-cell non-Hodgkin lymphoma

As listed by the trial registrant

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

Advanced malignancies Melanoma Ovarian cancer T-cell lymphoma

How to take part

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

  1. The places running it

    20 sites in 6 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

  • Byudzhetnoye Uchrezhdeniye Zdravookhraneniya Omskoy Oblasti - Klinicheskiy Onkologicheskiy Dispanser

    TERMINATED

    Omsk, 644013, Russia

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Debreceni Egyetem Klinikai Központ

    WITHDRAWN

    Debrecen, 4032, Hungary

  • Guy's and Saint Thomas' NHS Foundation Trust

    RECRUITING

    London, SE1 9RT, United Kingdom

  • Herlev Hospital

    RECRUITING

    Herlev, 2730, Denmark

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro-Majadahonda, Madrid,

    NOT_YET_RECRUITING

    Madrid, 28007, Spain

  • Institut Catala d'oncologia. Hospital Duran I Reynals

    NOT_YET_RECRUITING

    Barcelona, 08907, Spain

  • Karolinska University Hospital, Solna

    RECRUITING

    Stockholm, 17176, Sweden

  • Magyar Honvédség-Egészségügyi Központ

    RECRUITING

    Budapest, 1134, Hungary

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10021, United States

  • N.N. Petrov National Medical Research Center of Oncology

    WITHDRAWN

    Saint Petersburg, 197758, Russia

  • National Medical Research Center VA Almazov

    WITHDRAWN

    Saint Petersburg, 197022, Russia

  • PRA Health Sciences - Hungary

    ACTIVE_NOT_RECRUITING

    Budapest, 1077, Hungary

  • Rigshospitalet

    RECRUITING

    Copenhagen, Denmark

  • START Madrid - Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, 41345, Sweden

  • Sarah Cannon Research Institute UK

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Skanes University Hospital

    RECRUITING

    Lund, 223 70, Sweden

  • Southampton General Hospital

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden Hospital NHS Foundation Trust

    RECRUITING

    London, United Kingdom

  • University Hospital Birmingham

    RECRUITING

    Birmingham, United Kingdom

  • University Hospitals of Leicester NHS Trust

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

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Other studies related to the condition(s) this trial covers.