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

Launched by BEIGENE · Sep 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BG-C477 for people with advanced solid tumors, which are types of cancer that are hard to treat and have spread in the body. The main goals of the study are to find out if BG-C477 is safe, how the body processes it, and whether it can help shrink tumors when used alone or with other cancer treatments. The trial is currently looking for participants aged between 65 and 74 who have already received at least two prior treatments for their cancer and have a measurable tumor.

To be eligible for the study, participants need to agree to provide a tumor sample and must be able to give their consent for the trial. They should also be in relatively good health, with stable organ function and no serious allergic reactions to similar treatments. Participants will be monitored closely throughout the study and may experience side effects, like with any cancer treatment, but the study aims to ensure their safety. It’s important that female participants use effective birth control during the study and for some time after, as the effects of the drug on pregnancy are not fully known. Overall, this trial represents a hopeful option for patients seeking new treatments for challenging cancers.

Gender

ALL

Eligibility criteria

• 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.