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

Last updated: January 22, 2026
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

BGB-C354

Tislelizumab

Clinical Study ID

NCT06422520
BGB-C354-101
2024-513280-11-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Able to provide a signed and dated written informed consent prior to anystudy-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, orunresectable solid tumors, whose cancer is not amenable to therapy with curativeintent:

  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 ≥ 7 months after the lastdose of study drug(s).

  8. Nonsterile males must be willing to use a highly effective method of birth controlfor the duration of the study treatment period and for ≥ 4 months after the lastdose of study drug(s).

Exclusion

Exclusion Criteria:

  1. Prior treatment with B7H3-targeted therapy.

  2. For Part B and Phase 1b: Prior treatment with antibody drug conjugates (ADCs) withtopoisomerase I inhibitor payload (for Phase 1b, unless otherwise specified forspecific cohorts).

  3. Participants with spinal cord compressions, active leptomeningeal disease oruncontrolled, or untreated brain metastasis

  4. Any malignancy ≤ 2 years before the first dose of study treatment(s) except for thespecific cancer under investigation in this study and any locally recurring cancerthat has been treated with curative intent (eg, resected basal or squamous cell skincancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).

  5. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygensaturation 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 daysbefore the first dose of study drug(s).

  7. Infection (including tuberculosis infection) requiring systemic (oral orintravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before thefirst dose of study treatment(s).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: BGB-C354
Phase: 1
Study Start date:
July 08, 2024
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead 2143973, New South Wales 2155400 NSW 2145
    Australia

    Active - Recruiting

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • St Vincents Hospital Melbourne

    Fitzroy 2166584, Victoria 2145234 VIC 3065
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne 2158177, Victoria 2145234 VIC 3004
    Australia

    Active - Recruiting

  • One Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • One Clinical Research

    Nedlands 2064874, Western Australia 2058645 WA 6009
    Australia

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing 1816670, Beijing Municipality 2038349 100142
    China

    Active - Recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital

    Nanning 1799869, Guangxi 1809867 530021
    China

    Site Not Available

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Site Not Available

  • Hubei Cancer Hospital

    Wuhan 1791247, Hubei 1806949 430079
    China

    Active - Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin 130021
    China

    Site Not Available

  • Jilin Cancer Hospital

    Changchun 2038180, Jilin 2036500 130021
    China

    Active - Recruiting

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning 110042
    China

    Site Not Available

  • Liaoning Cancer Hospital and Institute

    Shenyang 2034937, Liaoning 2036115 110042
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu 1815286, Sichuan 1794299 610041
    China

    Active - Recruiting

  • Florida Cancer Specialist Research Institute Lake Nona

    Orlando, Florida 32827-7400
    United States

    Site Not Available

  • Florida Cancer Specialist Research Institute Lake Nona

    Orlando 4167147, Florida 4155751 32827-7400
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215-5418
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215-5418
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110-1010
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110-1010
    United States

    Active - Recruiting

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Site Not Available

  • Next Oncology

    San Antonio, Texas 78229-6028
    United States

    Site Not Available

  • Next Oncology

    Austin 4671654, Texas 4736286 78758
    United States

    Active - Recruiting

  • The University of Texas Md Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030-4009
    United States

    Active - Recruiting

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