Brief Summary
This is a first-in-human, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advancedat a late stage, far along solid tumors.
Study details include:
- The study will be conducted in 2 phases: Phase 1a (Monotherapy Dosethe amount of medication taken Escalation and Safety Expansion) and Phase 1b (Dose Expansion).
- The visit frequency will be approximately every 21 days during study treatment.
- The study duration is estimated to be approximately 5 years.
Intervention / Treatment
- Drug: BGB-C354
- Drug: Tislelizumab
Inclusion Criteria:
- Able to provide a signed and dated written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. prior to any study-specific procedures, sampling, or data collection.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance Status of 0 or 1.
- Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs is not amenable to therapy with curative intent:
- ≥ 1 measurable lesion per RECIST v1.1.
- Able to provide an archived tumor tissuea group of cells that work together to perform a function sample.
- Adequate organ function.
- Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s).
- Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).