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

NCT ID: NCT06422520

Last Updated: 2026-02-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-08
• Study Completion Date: 2027-01-31

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 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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1a: Part A (Monotherapy Dose Escalation)

BGB-C354 monotherapy doses at sequentially increasing levels.

Group Type: EXPERIMENTAL

BGB-C354

Intervention Type: DRUG

Administered by intravenous infusion

Phase 1a: Part B (Safety Expansion)

Participants will enroll at safe dose levels recommended by the Safety Monitoring Committee (SMC) for further evaluation.

Group Type: EXPERIMENTAL

BGB-C354

Intervention Type: DRUG

Administered by intravenous infusion

Phase 1b: Part C (Monotherapy Expansion)

BGB-C354 will be administered at the recommended dose for expansion (RDFE).

Group Type: EXPERIMENTAL

BGB-C354

Intervention Type: DRUG

Administered by intravenous infusion

Phase 1b: Part D (Combination Therapy Expansion)

BGB-C354 and tislelizumab will be adminsitered at doses determined by the SMC.

Group Type: EXPERIMENTAL

BGB-C354

Intervention Type: DRUG

Administered by intravenous infusion

Tislelizumab

Intervention Type: DRUG

Administered by intravenous infusion

Interventions

BGB-C354

Administered by intravenous infusion

Intervention Type: DRUG

Tislelizumab

Administered by intravenous infusion

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BeiGene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

BeiGene

Locations

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

Next Oncology

Austin, Texas, United States

The University of Texas Md Anderson Cancer Center

Houston, 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

Countries

United States; Australia; China

Other Identifiers

2024-513280-11-00

Identifier Type: CTIS

Identifier Source: secondary_id

BGB-C354-101

Identifier Type: -

Identifier Source: org_study_id