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RecruitingLast updated: 15 April 2026

BG-C477-101: This study will check how safe and helpful a new drug called BG-C477 is by itself or combined with other treatments in people with advanced solid tumoursA Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients With Selected Advanced Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Trial acronym

BG-C477-101

Clinical summary

Summary

The purpose of this study is to test if the drug BG-C477 is safe and if it works in people with selected advanced solid cancers when it is given on its own and in combination with other anticancer treatments. This study has four parts.

In Phase 1a (Dose Escalation), sequential cohorts of participants will receive increasing dose levels of BG-C477 by itself. Phase 1a (Safety Expansion) will then continue to measure the safety of BG-C477 in selected dose levels that have been determined to be safe in the previous phase.

In Phase 1b Part A (Dose Optimisation), participants with selected advanced solid tumors will be evaluated at different dose levels of BG-C477 identified in Phase 1a.

Finally in Phase 1b Part B (Combination Therapy Expansion) increasing dose levels of BG-C477 will be given in combination with chemotherapy (capecitabine) and targeted therapy (bevacizumab).

Conditions

This trial is treating people with advanced, metastatic, or unresectable solid cancers

Eligibility

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)

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

BeiGene

Scientific Title

A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients With Selected Advanced Solid Tumors

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