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Study identifier: NCT06233942 Synced from ClinicalTrials.gov · August 09, 2026
● Study status: 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

Condition: Advanced Solid Tumor  ·  Sponsor: BeOne Medicines

PhasePhase 1
Planned participants308
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where37 locations · 5 countries

Interested? Contact the study team ↓

For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Study Director  ·  1.877.828.5568  ·  clinicaltrials@beonemed.com

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: 1. Able to provide a signed and dated written informed consent prior to any study-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 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: 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 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). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (37)

Usc Norris Comprehensive Cancer Center (Nccc)Los Angeles, California, United StatesRecruiting
University of Colorado Cancer CenterAurora, Colorado, United StatesRecruiting
Florida Cancer Specialist Research Institute Lake NonaOrlando, Florida, United StatesRecruiting
Sidney Kimmel Comprehensive Cancer At Johns HopkinsBaltimore, Maryland, United StatesRecruiting
James Cancer Hospital and Solove Research InstituteColumbus, Ohio, United StatesRecruiting
Blacktown Cancer and Haematology CentreBlacktown, New South Wales, AustraliaRecruiting
Macquarie UniversityNorth Ryde, New South Wales, AustraliaRecruiting
Cancer Care WollongongWollongong, New South Wales, AustraliaRecruiting
Princess Alexandra HospitalWoolloongabba, Queensland, AustraliaRecruiting
Monash HealthClayton, Victoria, AustraliaRecruiting
Cabrini Hospital MalvernMalvern, Victoria, AustraliaRecruiting
Peter Maccallum Cancer CentreMelbourne, Victoria, AustraliaRecruiting

+ 25 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

Los AngelesAuroraOrlandoBaltimore

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