Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors

Launched by BEIGENE · Jan 23, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called BG-C9074, both by itself and when combined with another drug called tislelizumab, for patients with advanced solid tumors that cannot be surgically removed. The main goals of this study are to find out how safe these treatments are, how the body processes them, and if they can help shrink tumors. Participants will receive the study drugs for as long as they are tolerating the treatment without serious side effects or disease progression, with a maximum treatment period of up to two years.

To be eligible for this trial, participants should be between 65 and 74 years old and must be able to give informed consent. They should also have a confirmed diagnosis of a specific advanced cancer that has been treated before and have at least one measurable tumor for assessment. Additionally, they need to have adequate organ function and be willing to take precautions if they can become pregnant. It's important to note that certain health conditions, like uncontrolled diabetes or a history of severe lung disease, may exclude someone from participating. Overall, this trial offers a potential new treatment option for individuals with advanced solid tumors, and participants can expect close monitoring throughout their time in the study.

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 ≤ 1.
• • 3. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated.
• • 4. ≥ 1 measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
• • 5. Able to provide an archived tumor tissue sample.
• • 6. Adequate bone marrow and 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 a B7 homolog 4 (B7H4)-targeting antibody-drug conjugate (ADC) or an ADC with a topoisomerase 1 inhibitor (TOP1i) payload.
• • 2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
• • 3. 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).
• • 4. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen (including intermittent use) at baseline.
• • 5. Uncontrolled diabetes.
• • 6. 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.