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A Study of BG-C477 for Advanced Solid Tumors

This study is looking into a potential new cancer drug called BG-C477. Researchers want to see how safe BG-C477 is, how well your body handles it, and if it can help shrink advanced solid tumors. BG-C477 will be given by itself or in combination with other cancer treatments like Tislelizumab and chemotherapy. The study will also look at how BG-C477 works in your body. You might be able to join if you have advanced, metastatic, or unresectable solid tumors that have already been treated with at least two other therapies. The main goals are to find the safest dose of BG-C477 and to track any side effects. This study aims to enroll 310 participants, but its current status is unclear.

Study design
This is an interventional study that plans to enroll 310 participants. It will test BG-C477 alone and in combination with other anticancer agents.
What's involved
You would need to sign an informed consent form and provide a tumor tissue sample. The study will track side effects from your first dose until 30 days after your last dose, for up to approximately 2 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events and serious adverse events for up to 30 days after the last dose of the study drug(s), which could be up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06596473

A Study of BG-C477 in Participants With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
BeOne Medicines
~310 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:BG-C477TislelizumabChemotherapy

At a glance

Recruiting sites
59 of 59 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured over From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
+4 more outcomes measured

Conditions

Advanced Solid Tumors

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Solid Neoplasm

NCT06596473

Where you'd take part

This study runs at 59 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, South Koreano site contact published

    Recruiting

  • Auckland City Hospital

    Auckland, New Zealandno site contact published

    Recruiting

  • Beijing Chest Hospital, Capital Medical University

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, Australiano site contact published

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • Cancer Institute Hospital of Jfcr

    Kotoku, Tokyo, Japanno site contact published

    Recruiting

  • Cancer Research South Australia

    Adelaide, South Australia, Australiano site contact published

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, Chinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Study Director · STUDY_DIRECTOR · BeOne Medicines

Who to contact

Study Director
[email protected]
1.877.828.5568
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)

    Number of participants with AEs and SAEs, including findings from abnormal laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined Adverse Event of Clinical Interest (AECI) criteria.

  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)Approximately 1 year

    MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.

  • Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C477Approximately 1 year

    RDFE of BG-C477 monotherapy will be determined based upon available data.

  • Phase 1b: Overall Response Rate (ORR)Approximately 2 years

    ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

  • Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C477Approximately 2 years

    RP2D of BG-C477 alone and in combination with anticancer agents will be determined based upon available data.