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

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT06596473

Run by

BeOne Medicines

People needed

310

Starts

2024-10-03

Expected to finish

2027-12-31

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States (enrolling)
• University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• Yale University Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Osf Saint Francis Medical Center — Peoria, Illinois, United States (enrolling)
• The University of Kansas Cancer Center — Westwood, Kansas, United States (enrolling)
• John Theurer Cancer Center Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• The University of Texas Md Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Texas Oncology Longview — Longview, Texas, United States (enrolling)
• Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia (enrolling)
• Northern Beaches Hospital — Frenchs Forest, New South Wales, Australia (enrolling)
• Sunshine Coast University Private Hospital — Birtinya, Queensland, Australia (enrolling)
• Cancer Research South Australia — Adelaide, South Australia, Australia (enrolling)
• The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
• One Clinical Research — Nedlands, Western Australia, Australia (enrolling)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
• Beijing Chest Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• Sun Yat Sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• Guangxi Medical University Cancer Hospital Wuxiang Branch — Nanning, Guangxi, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
• Jiamusi Cancer Hospital — Jiamusi, Heilongjiang, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• City of Hope Phoenix Cancer Center — Goodyear, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.