A Study of BG-C477 in Participants With Advanced Solid Tumors
NCT ID: NCT06596473
Last Updated: 2025-11-12
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
21 participants
INTERVENTIONAL
2024-10-03
2028-10-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase 1a: BG-C477 Monotherapy Dose Escalation
Sequential cohorts of increasing dose levels of BG-C477 will be evaluated as monotherapy.
BG-C477
Administered intravenously.
Phase 1a: BG-C477 Monotherapy Safety Expansion
Selected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in monotherapy.
BG-C477
Administered intravenously.
Phase 1b Part A: BG-C477 Monotherapy Dose Optimization
Participants with selected advanced solid tumors will be evaluated at different dose levels of RDFEs identified in Phase 1a.
BG-C477
Administered intravenously.
Phase 1b Part B: Combination Therapy Expansion
Sequential cohorts of increasing dose levels of BG-C477 will be evaluated in combination with chemotherapy.
BG-C477
Administered intravenously.
Chemotherapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BG-C477
Administered intravenously.
Chemotherapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy
* Phase 1a (Dose Escalation); Histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, who were previously treated with at least 2 lines of standard systemic therapy or for whom no standard treatment is available in the medical judgment of the investigator
* ≥ 1 measurable lesion as assessed by RECIST v1.1
* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
* Adequate organ function
* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 8 months after the last dose of BG-C477 and for ≥ 6 months after the last dose of chemotherapy, whichever comes later
* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for ≥ 5 months after the last dose of BG-C477, and for ≥ 3 months after chemotherapy, whichever comes later.
Exclusion Criteria
* History of severe allergic reactions, severe reaction to infusion, or hypersensitivity to the active ingredient and excipients of the study drug(s) or protein-based therapeutics
* Active leptomeningeal disease or uncontrolled, untreated brain metastasis
* Any malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
BeiGene
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope National Medical Center
Duarte, California, United States
Yale University, Yale Cancer Center
New Haven, Connecticut, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
One Clinical Research
Nedlands, Western Australia, Australia
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, China
Jining No Peoples Hospital East Branch
Jining, Shandong, China
Auckland City Hospital
Auckland, , New Zealand
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTR20244563
Identifier Type: REGISTRY
Identifier Source: secondary_id
BG-C477-101
Identifier Type: -
Identifier Source: org_study_id