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

Completed · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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 advanced solid tumors. Study details include: * The study will be conducted in 2 phases: Phase 1a (Monotherapy Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion). * The visit frequency will be approximately every 21 days during study treatment. Maximum treatment duration will be up to two years. * The study duration is estimated to be approximately 5 years.

Key facts

Study ID

NCT06422520

Run by

BeOne Medicines

People needed

63

Starts

2024-07-08

Expected to finish

2026-05-15

Last updated by the study team

2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancer is not amenable to therapy with curative intent:
• ≥ 1 measurable lesion per RECIST v1.1.
• Able to provide an archived tumor tissue 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).

You may not qualify if…

• Prior treatment with B7H3-targeted therapy.
• 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).
• Participants with spinal cord compressions, active leptomeningeal disease or uncontrolled, or untreated brain metastasis
• 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).
• History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest < 92%, or requirement for supplemental oxygen at baseline
• 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).
• 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 it is running

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

Full record on ClinicalTrials.gov

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