Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors
NCT ID: NCT06233942
Last Updated: 2026-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
308 participants
INTERVENTIONAL
2024-04-12
2028-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase 1a: Part A (Monotherapy Dose Escalation)
BG-C9074 monotherapy dose escalation
BG-C9074
administered by intravenous infusion
Phase 1a: Part B (Monotherapy Safety Expansion)
BG-C9074 dose levels that have been determined to be safe and tolerable in Part A will be investigated.
BG-C9074
administered by intravenous infusion
Phase 1a: Part C (Combination Therapy Dose Escalation)
BG-C9074 plus tislelizumab combination at the recommended dose for expansion (RDFE).
BG-C9074
administered by intravenous infusion
Tislelizumab
administered by intravenous infusion
Phase 1a: Part D (Japan Cohort)
A separate cohort in Japan will evaluate the safety of BG-C9074 monotherapy in Japanese participants with select solid tumors
BG-C9074
administered by intravenous infusion
Phase 1b: Monotherapy Dose Expansion
The monotherapy dose expansion phase will begin once the BG-C9074 monotherapy RDFE and dosing schedule have been determined from Parts A and B in Phase 1a.
BG-C9074
administered by intravenous infusion
Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus tislelizumab)
This arm will assess BG-C9074 plus tislelizumab as first-line therapy in select solid tumors after completion of the dose escalation phase.
BG-C9074
administered by intravenous infusion
Tislelizumab
administered by intravenous infusion
Phase 1b: Combination Therapy Dose Expansion (BG-C9074 plus bevacizumab)
This arm will assess BG-C9074 plus bevacizumab in select solid tumors participants after establishing the recommended monotherapy dose and schedule.
BG-C9074
administered by intravenous infusion
Bevacizumab
administered by intravenous infusion
Interventions
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BG-C9074
administered by intravenous infusion
Tislelizumab
administered by intravenous infusion
Bevacizumab
administered by intravenous infusion
Eligibility Criteria
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Inclusion Criteria
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 standard systemic 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 be limited to participants with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer, cholangiocarcinoma (CCA), endometrial cancer, squamous non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), or ovarian cancer. Enrollment in the Japan cohort will be limited to participants with HR+/HER2- breast cancer, TNBC, endometrial cancer, or ovarian cancer.
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 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
2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
3. 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).
4. History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen (including intermittent use) at baseline.
5. Uncontrolled diabetes.
6. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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Usc Norris Comprehensive Cancer Center (Nccc)
Los Angeles, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Florida Cancer Specialist Research Institute Lake Nona
Orlando, Florida, United States
Sidney Kimmel Comprehensive Cancer At Johns Hopkins
Baltimore, Maryland, United States
James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Macquarie University
North Ryde, New South Wales, Australia
Cancer Care Wollongong
Wollongong, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Cabrini Hospital Malvern
Malvern East, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Weifang Peoples Hospital
Weifang, Shandong, China
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Other Identifiers
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BG-C9074-101
Identifier Type: -
Identifier Source: org_study_id
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