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New drug combo shows promise for Hard-to-Treat cancers

NCT ID NCT05935098

Disease control Sponsor: BeiGene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 study tested a new experimental drug, BGB-A3055, alone or with another drug (tislelizumab), in people with advanced or metastatic solid tumors. The goal was to check safety, how the body handles the drug, and any early signs of tumor shrinkage. The study was stopped early, but results may still help guide future research.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

99 people

The number who actually took part.

Started

Aug 2023

Finished

Jan 2026

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: 1. Age≥18 years on the day of signing the informed consent form (ICF) (or the legal age of consent in the jurisdiction in which the study is taking place, whichever is older). 2. All participants are also required to demonstrate an ECOG Performance Status score of ≤1 within 3 days before the first dose of study drug(s) and have adequate organ function. 3. Participants with histologically confirmed advanced or metastatic solid tumors associated with high CCR8 and who have previously received adequate available standard systemic therapy or for whom treatment is not available or not tolerated and who have not received any prior therapy targeting CCR8. 4. \>=1 Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 5. Participants should be able to provide archival tumor tissue samples (as block or unstained slides) or fresh biopsy if there is no archival tissue at baseline. For selected cohorts, participants should be willing to provide post-treatment fresh biopsy at specified timepoints. 6. Females of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 120 days after the last dose of BGB-A3055 or tislelizumab (whichever is later), or up to 9 months after the last dose of chemotherapy, whichever is later. Females of childbearing potential must also have a negative urine or serum pregnancy test result ≤ 7 days before the first dose of study drug(s). Exclusion Criteria: 1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis. 2. Active autoimmune diseases or history of autoimmune diseases that may relapse 3. Any malignancy ≤ 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast). 4. Participants with hepatitis B infection with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL). Participants with active hepatitis C, and participants with HIV infection. Note: Participants with chronic hepatitis B infection or resolved hepatitis B infection (HBV DNA \< 500 IU/mL or \< 2500 copies/mL) and considered stable are eligible. Participants with a negative HCV antibody test result at screening or a positive HCV antibody test result followed by a negative HCV RNA test result at screening are eligible to participate. Participants with treated HIV infection may be included if certain criteria are met. 5. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, or acute lung diseases. 6. Grade 3 immune-mediated adverse events on prior immune-oncology agent. 7. Cardiovascular risk factors, including but not limited to pulmonary embolism ≤ 28 days or history of acute myocardial infarction or heart failure ≤ 6 months before the first dose of study drug(s). 8. Uncontrolled diabetes. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

Advanced solid tumor Metastatic solid tumor Solid tumor

Contacts and locations

Locations

  • Advent Health Cancer Institute

    Orlando, Florida, 32804-4603, United States

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    Bordeaux, 33000, France

  • Changzhi Peoples Hospital

    Changzhi, Shanxi, 046099, China

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030, China

  • Chris Obrien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-4433, United States

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Ico Site Rene Gauducheau

    SaintHerblain, 44805, France

  • Icon Cancer Centre South Brisbane

    South Brisbane, Queensland, 4101, Australia

  • Institut Curie

    Paris, 75005, France

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • John Theurer Cancer Center Hackensack University Medical Center

    Hackensack, New Jersey, 07601-2191, United States

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042, China

  • Linear Clinical Research

    Nedlands, Western Australia, 6009, Australia

  • Next Dallas

    Irving, Texas, 75039-2743, United States

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicinejiading Branch

    Shanghai, Shanghai Municipality, 201801, China

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Bundang Hospital

    BundangGu SeongnamSi, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242-1009, United States

More trials for these conditions

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