Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors

Last updated: April 14, 2026
Sponsor: BeOne Medicines
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

Tislelizumab

Bevacizumab

BG-C9074

Clinical Study ID

NCT06233942
BG-C9074-101
2023-509958-65-00
jRCT2031250755
  • 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 other anticancer therapies in patients 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 previously received standardsystemic therapy and whose cancer is not amenable to therapy with curative intent,and for whom further treatment is not available or not tolerated. Enrollment will belimited to participants with hormone receptor-positive/human epidermal growth factorreceptor 2-negative (HR+/HER2-) breast cancer, cholangiocarcinoma (CCA), endometrialcancer, squamous non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), or ovarian cancer. Enrollment in the Japan cohort will be limited toparticipants with HR+/HER2- breast cancer, TNBC, endometrial cancer, or ovariancancer.

  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: 308
Treatment Group(s): 3
Primary Treatment: Tislelizumab
Phase: 1
Study Start date:
April 12, 2024
Estimated Completion Date:
May 15, 2028

Connect with a study center

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales NSW 2148
    Australia

    Active - Recruiting

  • Macquarie University

    North Ryde, New South Wales NSW 2109
    Australia

    Active - Recruiting

  • Cancer Care Wollongong

    Wollongong, New South Wales NSW 2500
    Australia

    Active - Recruiting

  • Blacktown Cancer and Haematology Centre

    Blacktown 2175411, New South Wales 2155400 NSW 2148
    Australia

    Site Not Available

  • Macquarie University

    North Ryde 7281782, New South Wales 2155400 NSW 2109
    Australia

    Site Not Available

  • Cancer Care Wollongong

    Wollongong 2171507, New South Wales 2155400 NSW 2500
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Brisbane, Queensland 4102
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland QLD 4102
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba 6943568, Queensland 2152274 QLD 4102
    Australia

    Site Not Available

  • Monash Health

    Clayton, Victoria VIC 3168
    Australia

    Active - Recruiting

  • Cabrini Hospital Malvern

    Malvern East, Victoria VIC 3144
    Australia

    Active - Recruiting

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria VIC 3000
    Australia

    Active - Recruiting

  • Monash Health

    Clayton 2171400, Victoria 2145234 VIC 3168
    Australia

    Site Not Available

  • Cabrini Hospital Malvern

    Malvern East 7932638, Victoria 2145234 VIC 3144
    Australia

    Site Not Available

  • Peter Maccallum Cancer Centre

    Melbourne 2158177, Victoria 2145234 VIC 3000
    Australia

    Site Not Available

  • Linear Clinical Research

    Nedlands, Western Australia WA 6009
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Nedlands 2064874, Western Australia 2058645 WA 6009
    Australia

    Site Not Available

  • Hospital Sirio Libanes Brasilia

    Brasília, 70200-730
    Brazil

    Active - Recruiting

  • Liga Norte Riograndene Contra O Cancer

    Natal, 59062-000
    Brazil

    Active - Recruiting

  • Liga Norte Riograndene Contra O Cancer

    Natal 3394023, 59062-000
    Brazil

    Site Not Available

  • Hospital Sao Lucas Da Pucrs

    Porto Alegre, 90610-000
    Brazil

    Active - Recruiting

  • Instituto Nacional de Cancer Hospital Do Cancer Ii

    Rio de Janerio, 20220-410
    Brazil

    Active - Recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    São José do Rio Preto, 15090-000
    Brazil

    Active - Recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    São José do Rio Preto 3448639, 15090-000
    Brazil

    Site Not Available

  • Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria

    São Paulo, 01318-001
    Brazil

    Active - Recruiting

  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

    São Paulo, 01246-000
    Brazil

    Active - Recruiting

  • Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

    São Paulo 3448439, 01246-000
    Brazil

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality 100021
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing 1816670, Beijing Municipality 2038349 100021
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian 350025
    China

    Suspended

  • Fujian Cancer Hospital

    Fuzhou 1810821, Fujian 1811017 350014
    China

    Site Not Available

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou 1809858, Guangdong 1809935 510060
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Scienceslangfang Branch

    Langfang, Hebei 065001
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Scienceslangfang Branch

    Langfang 1804540, Hebei 1808773 065001
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin 2037013, Heilongjiang 2036965 150000
    China

    Site Not Available

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Site Not Available

  • 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

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

    Wuhan 1791247, Hubei 1806949 430030
    China

    Active - Recruiting

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

    Wuhan 1791247, Hubei 1806949 430022
    China

    Site Not Available

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning 116023
    China

    Active - Recruiting

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning 110042
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110004
    China

    Active - Recruiting

  • The Second Hospital of Dalian Medical University

    Dalian 1814087, Liaoning 2036115 116023
    China

    Site Not Available

  • Liaoning Cancer Hospital and Institute

    Shenyang 2034937, Liaoning 2036115 110042
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang 2034937, Liaoning 2036115 110004
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xian Jiaotong University

    Xian, Shaanxi 710061
    China

    Site Not Available

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an 1790630, Shaanxi 1796480 710061
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250000
    China

    Active - Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong 272000
    China

    Active - Recruiting

  • Weifang Peoples Hospital

    Weifang, Shandong 261000
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan 1805753, Shandong 1796328 250000
    China

    Site Not Available

  • Affiliated Hospital of Jining Medical University

    Jining 1805518, Shandong 1796328 272000
    China

    Site Not Available

  • Weifang Peoples Hospital

    Weifang 1791681, Shandong 1796328 261000
    China

    Site Not Available

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Obstetrics and Gynecology Hospital of Fudan University

    Shanghai, Shanghai Municipality 200011
    China

    Active - Recruiting

  • Obstetrics and Gynecology Hospital of Fudan University

    Shanghai 1796236, Shanghai Municipality 1796231 200011
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality 300060
    China

    Active - Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin 1792947, Tianjin Municipality 1792943 300060
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou 1808926, Zhejiang 1784764 310022
    China

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Active - Recruiting

  • Cancer Institute Hospital of Jfcr

    Kotoku, Tokyo 135-8550
    Japan

    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

  • Cha Bundang Medical Center, Cha University

    BundangGu SeongnamSi, Gyeonggi-do 1841610 13496
    South Korea

    Site Not Available

  • Seoul National University Bundang Hospital

    BundangGu SeongnamSi, Gyeonggi-do 1841610 13620
    South Korea

    Site Not Available

  • National Cancer Center (Korea)

    IlsandongGu GoyangSi, Gyeonggi-do 1841610 10408
    South Korea

    Site Not Available

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi 06351
    South Korea

    Site Not Available

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi 03722
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, Seoul Teugbyeolsi 03080
    South Korea

    Site Not Available

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi 05505
    South Korea

    Site Not Available

  • Usc Norris Comprehensive Cancer Center (Nccc)

    Los Angeles, California 90089-1019
    United States

    Active - Recruiting

  • Usc Norris Comprehensive Cancer Center (Nccc)

    Los Angeles 5368361, California 5332921 90089-1019
    United States

    Site Not Available

  • University of Colorado Cancer Center

    Aurora, Colorado 80045-2517
    United States

    Active - Recruiting

  • University of Colorado Cancer Center

    Aurora 5412347, Colorado 5417618 80045-2517
    United States

    Site Not Available

  • Florida Cancer Specialist Research Institute Lake Nona

    Orlando, Florida 32827-7400
    United States

    Active - Recruiting

  • Florida Cancer Specialist Research Institute Lake Nona

    Orlando 4167147, Florida 4155751 32827-7400
    United States

    Site Not Available

  • Sidney Kimmel Comprehensive Cancer At Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Sidney Kimmel Comprehensive Cancer At Johns Hopkins

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • James Cancer Hospital and Solove Research Institute

    Columbus, Ohio 43210-1240
    United States

    Active - Recruiting

  • James Cancer Hospital and Solove Research Institute

    Columbus 4509177, Ohio 5165418 43210-1240
    United States

    Site Not Available

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