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

Last updated: June 20, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

Tislelizumab

BG-C9074

Clinical Study ID

NCT06233942
BG-C9074-101
2023-509958-65-00
  • Ages > 18
  • All Genders

Study Summary

This is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C9074 alone and in combination with tislelizumab in participants with advanced solid tumors.

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 ≤ 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 methodof birth control for the duration of the study, and for ≥ 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 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 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).

  4. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygensaturation at rest < 92%, or requirement for supplemental oxygen (includingintermittent use) at baseline.

  5. Uncontrolled diabetes.

  6. 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: 227
Treatment Group(s): 2
Primary Treatment: Tislelizumab
Phase: 1
Study Start date:
April 12, 2024
Estimated Completion Date:
May 15, 2028

Connect with a study center

  • Macquarie University

    North Ryde, New South Wales 2109
    Australia

    Active - Recruiting

  • Cancer Care Wollongong

    Wollongong, New South Wales 2500
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Brisbane, Queensland 4102
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • Monash Health

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian 350025
    China

    Suspended

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Scienceslangfang Branch

    Langfang, Hebei 065001
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Suspended

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • The First Affiliated Hospital of Xian Jiaotong University

    Xian, Shaanxi 710061
    China

    Suspended

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250000
    China

    Completed

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong 272000
    China

    Site Not Available

  • Weifang Peoples Hospital

    Weifang, Shandong 261000
    China

    Site Not Available

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Suspended

  • Obstetrics and Gynecology Hospital of Fudan University

    Shanghai, Shanghai 200011
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Active - Recruiting

  • Cha Bundang Medical Center, Cha University

    BundangGu SeongnamSi, Gyeonggi-do 13496
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    BundangGu SeongnamSi, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • National Cancer Center (Korea)

    Goyangsi, Gyeonggi-do 10408
    Korea, Republic of

    Site Not Available

  • National Cancer Center (Korea)

    IlsandongGu GoyangSi, Gyeonggi-do 10408
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Usc Norris Comprehensive Cancer Center (Nccc)

    Los Angeles, California 90089-1019
    United States

    Active - Recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado 80045-2517
    United States

    Active - Recruiting

  • Florida Cancer Specialist Research Institute Lake Nona

    Orlando, Florida 32827-7400
    United States

    Active - Recruiting

  • Sidney Kimmel Comprehensive Cancer At Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • James Cancer Hospital and Solove Research Institute

    Columbus, Ohio 43210-1240
    United States

    Active - Recruiting

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