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A Study of BG-C477 in Participants With Advanced Solid Tumors
Trial Status: active
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.
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 or cytologically confirmed advanced, metastatic, or unresectable solid tumors, who 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
≥ 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 and for ≥ 6 months after the last dose of chemotherapy, 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, and for ≥ 3 months after chemotherapy, 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.
Additional locations may be listed on ClinicalTrials.gov for NCT06596473.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Trumbull
Smilow Cancer Hospital Care Center-Trumbull
Status: Active
Name Not Available
Kansas
Kansas City
University of Kansas Cancer Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
This new study will check how safe and helpful a potential anticancer drug called BG-C477
is. This drug will be tested by itself or combined with other anticancer agents. The
purpose of this study is to test if BG-C477 is safe and if it works in people with your
disease when it is given on its own and in combination with other anticancer agents.