A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

Launched by BEIGENE · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called BGB-C354, both on its own and together with another drug called tislelizumab, in patients with advanced solid tumors. The main goals of the study are to see how safe these treatments are, how the body processes them, and if they can help shrink tumors. The trial is divided into two parts: the first part will focus on finding the right dose and checking safety, while the second part will look at how well the treatment works at that dose.

To participate in this study, you should be an adult with a confirmed advanced solid tumor that cannot be treated with standard methods meant to cure it. You will need to be in relatively good health, able to give informed consent, and have at least one measurable tumor for the study. If you join, you can expect to visit the study site approximately every three weeks over a period of about five years. It’s important to note that both women and men who could become parents must agree to use effective birth control during the study and for a while after treatment. If this sounds like something you might be interested in, please talk to your healthcare provider for more information!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
• • 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• 3. Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancer is not amenable to therapy with curative intent:
• • 4. ≥ 1 measurable lesion per RECIST v1.1.
• • 5. Able to provide an archived tumor tissue sample.
• • 6. Adequate organ function.
• • 7. 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).
• • 8. 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).
• Exclusion Criteria:
• • 1. Prior treatment with B7H3-targeted therapy.
• • 2. For Part B and Phase 1b: Prior treatment with antibody drug conjugates (ADCs) with topoisomerase I inhibitor payload (for Phase 1b, unless otherwise specified for specific cohorts).
• • 3. Participants with spinal cord compressions, active leptomeningeal disease or uncontrolled, or untreated brain metastasis
• • 4. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
• • 5. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen at baseline
• • 6. Uncontrolled diabetes, or \> Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium levels despite standard medical management ≤ 14 days before the first dose of study drug(s).
• • 7. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).
• • Note: Other protocol defined Inclusion/Exclusion criteria may apply.