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New drug BG-C477 enters human testing for Hard-to-Treat cancers

NCT ID NCT06596473

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 04, 2026 · Updated 4 times

Summary

This early-phase study tests a new drug, BG-C477, in about 310 people with advanced solid tumors that have not responded to standard treatments. The main goals are to check the drug's safety, find the best dose, and see if it can shrink tumors. The study is open-label, meaning everyone knows they are getting the drug.

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

About 310 people

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

Started

Oct 2024

Expected to finish

Dec 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: * Participants must sign the informed consent form (ICF) and be capable of giving written informed consent * Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy * Phase 1a (Dose Escalation): Histologically confirmed advanced, metastatic, or unresectable solid tumors, that were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator * Phase 1b (Dose Expansion) Part A: Histologically confirmed advanced or metastatic select solid tumors that were previously treated with and progressed from at least 1 line of standard systemic therapy * Phase 1b (Dose Expansion) Part B: Histologically confirmed advanced or metastatic select solid tumors who have previously received 0 or 1 line of systemic therapy for advanced disease * ≥ 1 measurable lesion as assessed by RECIST v1.1 * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 * Adequate organ function * Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 8 months after the last dose of BG-C477, for ≥ 6 months after the last dose of chemotherapy, and for ≥ 4 months after the last dose of tislelizumab,whichever comes later * Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 5 months after the last dose of BG-C477, for ≥ 3 months after chemotherapy, and for ≥ 4 months after the last dose of tislelizumab, whichever comes later. Exclusion Criteria: * Prior treatment with any carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload * History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics * Active leptomeningeal disease or uncontrolled, untreated brain metastasis * Any malignancy ≤ 2 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 curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast) Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Advanced solid tumors

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

    57 sites in 8 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

  • Asan Medical Center

    RECRUITING

    SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

  • Auckland City Hospital

    RECRUITING

    Auckland, 1023, New Zealand

  • Beijing Chest Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 101149, China

  • Blacktown Cancer and Haematology Centre

    RECRUITING

    Blacktown, New South Wales, NSW 2148, Australia

  • Cancer Hospital Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

  • Cancer Institute Hospital of Jfcr

    RECRUITING

    Kotoku, Tokyo, 135-8550, Japan

  • Cancer Research South Australia

    RECRUITING

    Adelaide, South Australia, SA 5000, Australia

  • Chongqing University Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400030, China

  • 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

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, Fujian, 350014, China

  • Guangxi Medical University Cancer Hospital Wuxiang Branch

    RECRUITING

    Nanning, Guangxi, 530201, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Hospital Kuala Lumpur

    RECRUITING

    Kuala Lumpur, 50586, Malaysia

  • Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)

    RECRUITING

    Kota Kinabalu Sabah, 88996, Malaysia

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, 430079, China

  • Jiamusi Cancer Hospital

    RECRUITING

    Jiamusi, Heilongjiang, 154004, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, Jiangxi, 330029, China

  • Jining No1 Peoples Hospital East Branch

    RECRUITING

    Jining, Shandong, 272002, China

  • John Theurer Cancer Center Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, Osaka, 573-1191, Japan

  • King Chulalongkorn Memorial Hospital (Chulalongkorn University)

    RECRUITING

    Pathum Wan, 10330, Thailand

  • Linyi Peoples Hospital Beicheng Branch

    RECRUITING

    Linyi, Shandong, 276005, China

  • Nanfang Hospital, Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • National Cancer Institute (Institut Kanser Negara)

    RECRUITING

    Putrajaya, 62250, Malaysia

  • Northern Beaches Hospital

    RECRUITING

    Frenchs Forest, New South Wales, NSW 2086, Australia

  • One Clinical Research

    RECRUITING

    Nedlands, Western Australia, WA 6009, Australia

  • Osf Saint Francis Medical Center

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Samsung Medical Center

    RECRUITING

    GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

  • Sarawak General Hospital

    RECRUITING

    Kuching, 93586, Malaysia

  • Seoul National University Bundang Hospital

    RECRUITING

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

  • Severance Hospital Yonsei University Health System

    RECRUITING

    SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Shizuoka Cancer Center

    RECRUITING

    Suntogun, Shizuoka, 411-8777, Japan

  • Siriraj Hospital

    RECRUITING

    Bangkok, 10700, Thailand

  • Srinagarind Hospital (Khon Kaen University)

    RECRUITING

    Muang, 40002, Thailand

  • Sun Yat Sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • Sunshine Coast University Private Hospital

    RECRUITING

    Birtinya, Queensland, QLD 4575, Australia

  • Sunway Medical Centre

    RECRUITING

    Petaling Jaya, 47500, Malaysia

  • Taizhou Hospital of Zhejiang Province (East)

    RECRUITING

    Taizhou, Zhejiang, 317004, China

  • Texas Oncology Longview

    RECRUITING

    Longview, Texas, 75601, United States

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, VIC 3004, Australia

  • The First Affiliated Hospital of Nanchang University Branch Xianghu

    RECRUITING

    Nanchang, Jiangxi, 332000, China

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital of Zhengzhou University

    ACTIVE_NOT_RECRUITING

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    RECRUITING

    Hangzhou, Zhejiang, 310002, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110001, China

  • The University of Kansas Cancer Center

    RECRUITING

    Westwood, Kansas, 66205-2003, United States

  • The University of Texas Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-4009, United States

  • Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

  • Tokyo Metropolitan Komagome Hospital

    RECRUITING

    Bunkyoku, Tokyo, 113-8677, Japan

  • University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045-2517, United States

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Yale University Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520-8028, United States

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, Yunnan, 650100, China

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