Actively Recruiting
Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors
Led by BeOne Medicines · Updated on 2026-04-15
308
Participants Needed
38
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed and dated written informed consent before any study procedures
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors
- Previously received standard systemic therapy with no curative treatment options available or tolerated
- Enrollment limited to hormone receptor-positive/HER2-negative breast cancer, cholangiocarcinoma, endometrial cancer, squamous non-small cell lung cancer, triple-negative breast cancer, or ovarian cancer
- Japan cohort limited to hormone receptor-positive/HER2-negative breast cancer, triple-negative breast cancer, endometrial cancer, or ovarian cancer
- At least one measurable lesion per RECIST v1.1 criteria
- Able to provide an archived tumor tissue sample
- Adequate bone marrow and organ function
- Females of childbearing potential willing to use highly effective birth control during the study and for at least 7 months after last dose
- Nonsterile males willing to use highly effective birth control during treatment and for at least 4 months after last dose
You will not qualify if you...
- Prior treatment with a B7 homolog 4 (B7H4)-targeting antibody-drug conjugate or ADC with a topoisomerase 1 inhibitor payload
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis
- Any malignancy within 2 years before first dose except the specific cancer studied and certain locally recurring cancers treated with curative intent
- History of interstitial lung disease or Grade 2 or higher noninfectious pneumonitis
- Oxygen saturation below 92% at rest or need for supplemental oxygen at baseline
- Uncontrolled diabetes
- Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before first dose of study treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 38 locations
1
Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, United States, 90089-1019
Actively Recruiting
2
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045-2517
Actively Recruiting
3
Florida Cancer Specialist Research Institute Lake Nona
Orlando, Florida, United States, 32827-7400
Actively Recruiting
4
Sidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
5
James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210-1240
Actively Recruiting
6
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia, NSW 2148
Actively Recruiting
7
Macquarie University
North Ryde, New South Wales, Australia, NSW 2109
Actively Recruiting
8
Cancer Care Wollongong
Wollongong, New South Wales, Australia, NSW 2500
Actively Recruiting
9
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, QLD 4102
Actively Recruiting
10
Monash Health
Clayton, Victoria, Australia, VIC 3168
Actively Recruiting
11
Cabrini Hospital Malvern
Malvern East, Victoria, Australia, VIC 3144
Actively Recruiting
12
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia, VIC 3000
Actively Recruiting
13
Linear Clinical Research
Nedlands, Western Australia, Australia, WA 6009
Actively Recruiting
14
Hospital Sirio Libanes Brasilia
Brasília, Brazil, 70200-730
Actively Recruiting
15
Liga Norte Riograndene Contra O Cancer
Natal, Brazil, 59062-000
Actively Recruiting
16
Hospital Sao Lucas Da Pucrs
Porto Alegre, Brazil, 90610-000
Actively Recruiting
17
Instituto Nacional de Cancer Hospital Do Cancer Ii
Rio de Janerio, Brazil, 20220-410
Actively Recruiting
18
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, Brazil, 15090-000
Actively Recruiting
19
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, Brazil, 01246-000
Actively Recruiting
20
Clinica de Pesquisa E Centro de Estudos Em Oncologia Ginecologica E Mamaria
São Paulo, Brazil, 01318-001
Actively Recruiting
21
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
22
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
23
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
24
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Actively Recruiting
25
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
26
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
27
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China, 116023
Actively Recruiting
28
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Actively Recruiting
29
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China, 110042
Actively Recruiting
30
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250000
Actively Recruiting
31
Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 272000
Actively Recruiting
32
Weifang Peoples Hospital
Weifang, Shandong, China, 261000
Actively Recruiting
33
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
34
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
35
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Completed
36
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
37
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
38
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, Japan, 135-8550
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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