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New hope for advanced cancers? first human trial launches

NCT ID NCT06427941

Disease control Sponsor: BeOne Medicines 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 17, 2026 · Updated 9 times

Summary

This early-stage study is testing a new drug called BGB-B2033, alone or with other drugs, in people with advanced liver, stomach, or lung cancers. The goal is to see if it is safe and how well it works. About 392 participants will take part.

What this could mean

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

Active substance
BGB-B2033, tislelizumab, bevacizumab
What this could lead to
If it works, this could point toward a new treatment option for certain advanced cancers like liver, stomach, and lung cancer.
What could go wrong
This is a very early (Phase 1) study, so the drug may not work or could have serious side effects. It is also small and not yet tested in many people.

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 630 people

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

Started

Jul 2024

Expected to finish

Oct 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.

Key Inclusion Criteria: 1. Participants must have one of the following unresectable, locally advanced, or metastatic tumor types: 1. Hepatocellular carcinoma (HCC): Histologically or cytologically confirmed HCC that is either Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is not amenable to, or has progressed after, loco-regional therapy and is not eligible for a curative treatment approach. 2. Alpha-fetoprotein (AFP)-producing gastric cancer (GC): Histologically confirmed GC with AFP \> 20 ng/mL in blood or tumor tissue positive for AFP by a validated immunohistochemistry (IHC) assay based on local or central testing. 3. Germ cell tumors: Histologically confirmed germ cell tumors including extragonadal yolk sac tumors (e.g., located in the mediastinum, vagina, brain, retroperitoneum), and non-dysgerminomas for which no further curative systemic treatment options exist. 4. Glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC): Histologically confirmed GPC3-positive squamous NSCLC with prior exposure to a checkpoint inhibitor (CPI). 2. At least one evaluable lesion for dose escalation, and at least one measurable lesion for safety expansion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 4. Adequate organ function as defined in the protocol. 5. Provision of tumor tissue samples is required for specified parts of the study. Key Exclusion Criteria: 1. Prior therapy directed against glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (CD137). 2. Active leptomeningeal disease or uncontrolled/untreated brain metastases. 3. Active autoimmune disease or a history of autoimmune disease with potential for relapse. 4. Any malignancy diagnosed ≤ 2 years before the first dose of study drug(s), except: The cancer type under investigation in this study, or Locally recurring malignancies previously treated with curative intent. 5. Requirement for systemic corticosteroids (\> 10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 14 days prior to the first dose of study drug(s). 6. Certain comorbidities involving the lungs, heart, bleeding conditions, or active infections, as defined in the protocol. Note: Additional protocol-defined inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

extragonadal germ cell tumor gastric cancer hepatocellular carcinoma metastatic malignant neoplasm non-small cell squamous lung carcinoma nongerminomatous germ cell tumor Simpson-Golabi-Behmel syndrome

As listed by the trial registrant

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

Advanced hepatocellular carcinoma Alpha-fetoprotein (AFP)-producing gastric cancer Extragonadal yolk sac tumors Glypican-3 (GPC3)-positive squamous non-small cell lung cancer Local advanced hepatocellular carcinoma Metastatic hepatocellular carcinoma Metastatic solid tumor

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    50 sites in 9 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, Anhui, 230000, China

  • Asan Medical Center

    RECRUITING

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Auckland City Hospital

    RECRUITING

    Auckland, 1023, New Zealand

  • Cancer Institute Hospital of Jfcr

    RECRUITING

    Kotoku, Tokyo, 135-8550, Japan

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    RECRUITING

    Nantes, 44000, France

  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

    RECRUITING

    Porto Alegre, 90110-270, Brazil

  • Cha Bundang Medical Center, Cha University

    RECRUITING

    BundangGu SeongnamSi, Gyeonggi-do, 13496, South Korea

  • Chongqing University Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400030, China

  • Chungbuk National University Hospital

    RECRUITING

    Cheongju-si, Chungcheongbukdo, 28644, South Korea

  • City of Hope Chicago Cancer Center

    RECRUITING

    Zion, Illinois, 60099, United States

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010-3012, United States

  • City of Hope Phoenix Cancer Center

    RECRUITING

    Goodyear, Arizona, 85338, United States

  • Fondazione Policlinico Universitario Agostino Gemelli

    RECRUITING

    Roma, 00168, Italy

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    RECRUITING

    São José do Rio Preto, 15090-000, Brazil

  • Fundacao Pio Xii Hospital de Amor de Barretos

    RECRUITING

    Barretos, 14.784-400, Brazil

  • Guangxi Medical University Cancer Hospital Wuxiang Branch

    RECRUITING

    Nanning, Guangxi, 530201, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • Hopital Beaujon

    RECRUITING

    Clichy, 92110, France

  • Hospital Da Bahia

    RECRUITING

    Salvador, 41810-011, Brazil

  • Hospital Oncologico

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410013, China

  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

    RECRUITING

    São Paulo, 01246-000, Brazil

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • Iov Istituto Oncologico Veneto Irccs

    RECRUITING

    Padova, 35128, Italy

  • Irccs Humanitas Research Hospital

    RECRUITING

    Rozzano, 20089, Italy

  • Irccs Istituto Nazionale Tumori Fondazione Pascale

    RECRUITING

    Naples, 80131, Italy

  • Kindai University Hospital

    RECRUITING

    Sakai, Osaka, 590-0197, Japan

  • Lishui Central Hospital

    RECRUITING

    Lishui, Zhejiang, 323000, China

  • Memorial Sloan Kettering Cancer Center Mskcc

    RECRUITING

    New York, New York, 10065-6800, United States

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    RECRUITING

    Fuzhou, Fujian, 350028, China

  • Nanfang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Samsung Medical Center

    RECRUITING

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Samsung Medical Center

    ACTIVE_NOT_RECRUITING

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Scri Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203-1503, United States

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    RECRUITING

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Sichuan Cancer Hospital and Institute

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • The Affiliated Hospital of Xuzhou Medical University

    RECRUITING

    Xuzhou, Jiangsu, 221000, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050011, China

  • The Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The Second Affiliated Hospital of Nanchang Universityhongjiaozhou Branch

    RECRUITING

    Nanchang, Jiangxi, 330038, China

  • The University of Texas Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-4009, United States

  • Tokyo Metropolitan Komagome Hospital

    RECRUITING

    Bunkyoku, Tokyo, 113-8677, Japan

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430030, China

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430022, China

  • University of Alabama At Birmingham Hospital

    RECRUITING

    Birmingham, Alabama, 35294-0004, United States

  • Upmc Hillman Cancer Center(Univ of Pittsburgh)

    RECRUITING

    Pittsburgh, Pennsylvania, 15232-1309, United States

  • Zhujiang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510000, China

More trials for these conditions

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