Testing BGB-C354 and Tislelizumab in Patients with Advanced Solid Tumors

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

This study is testing a new treatment called BGB-C354, both alone and with another drug called tislelizumab, to see if it can help people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BeiGene (industry)
• Drugs / interventions: tislelizumab
• Locations: 15 sites (Orlando, Florida and 14 other locations)
• Trial ID: NCT06422520 on ClinicalTrials.gov

What this trial studies

This is a first-in-human Phase 1 study evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors. The study consists of two phases: Phase 1a focuses on monotherapy dose escalation and safety expansion, while Phase 1b involves dose expansion. Participants will be monitored approximately every 21 days during the treatment period, which is expected to last around five years.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced, metastatic, or unresectable solid tumors who have measurable lesions and adequate organ function.

Not a fit: Patients who have previously received B7H3-targeted therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that are not amenable to curative therapies.

How similar studies have performed: Other studies involving similar combinations of therapies have shown promise, but this specific combination is novel.

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.

Where this trial is running

Orlando, Florida and 14 other locations

• Florida Cancer Specialist Research Institute Lake Nona — Orlando, Florida, United States (RECRUITING)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
• Washington University School of Medicine — Saint Louis, Missouri, United States (RECRUITING)
• The University of Texas Md Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• Next Oncology — San Antonio, Texas, United States (RECRUITING)
• Westmead Hospital — Westmead, New South Wales, Australia (RECRUITING)
• St Vincents Hospital Melbourne — Fitzroy, Victoria, Australia (RECRUITING)
• The Alfred Hospital — Melbourne, Victoria, Australia (RECRUITING)
• One Clinical Research — Nedlands, Western Australia, Australia (RECRUITING)
• Beijing Cancer Hospital — Beijing, Beijing, China (RECRUITING)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (RECRUITING)
• Hubei Cancer Hospital — Wuhan, Hubei, China (RECRUITING)
• Jilin Cancer Hospital — Changchun, Jilin, China (RECRUITING)
• Liaoning Cancer Hospital and Institute — Shenyang, Liaoning, China (RECRUITING)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Study coordinator: Study Director

Conditions: Advanced Solid Tumor, BGB-C354, Tislelizumab, First-in-human, Advanced solid tumor, Anti-PD-1 Monoclonal Antibody, B7H3, antibody drug conjugate