Recruiting
Phase 1

BG-C477

Sponsor:

BeOne Medicines

Code:

NCT06596473

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BG-C477

Tislelizumab

Chemotherapy

Study Details

Brief summary:

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.

Conditions

Advanced Solid Tumors

Study ID

NCT06596473

Start date

Oct 3, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

310 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a: BG-C477 Monotherapy Dose Escalation

Sequential cohorts of increasing dose levels of BG-C477 will be evaluated as monotherapy.

experimental: Phase 1a: BG-C477 Monotherapy Safety Expansion

Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in monotherapy.

experimental: Phase 1b Part A: BG-C477 Monotherapy Expansion and Dose Optimization

Participants with selected advanced solid tumors will be evaluated at different dose levels of RDFEs identified in Phase 1a.

experimental: Phase 1b Part B: Combination Therapy Expansion

Sequential cohorts of increasing dose levels of BG-C477 will be evaluated in combination with anticancer agents, including chemotherapy or tislelizumab.

Interventions

BG-C477

Administered intravenously.

Tislelizumab

Administered intravenously.

Chemotherapy

Administered in accordance with relevant local guidelines and/or prescribing information.

Primary outcome measure

  • Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years) ]
  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) [ Time Frame: Approximately 1 year ]
  • Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C477 [ Time Frame: Approximately 1 year ]
  • Phase 1b: Overall Response Rate (ORR) [ Time Frame: Approximately 2 years ]
  • Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C477 [ Time Frame: Approximately 2 years ]

Central Contacts and Locations

Central contacts

Study Director

1.877.828.5568clinicaltrials@beonemed.com

Locations

City of Hope Phoenix Cancer Center

Recruiting

Goodyear, Arizona, United States, 85338

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010-3012

University of Colorado Cancer Center

Recruiting

Aurora, Colorado, United States, 80045-2517

Yale University Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520-8028

Osf Saint Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

The University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205-2003

John Theurer Cancer Center Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

The University of Texas Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-4009

Texas Oncology Longview

Recruiting

Longview, Texas, United States, 75601

More Information

Sponsor

BeOne Medicines

Last update posted

Aug 3, 2026

Last verified

Mar, 2026

Keywords

  • BG-C477
  • advanced solid tumors
  • CEA ADC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-08-03.