A Study of BG-C477 in Participants With Advanced Solid Tumors
A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C477 in Patients With Selected Advanced Solid Tumors
2 other identifiers
interventional
310
6 countries
41
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C477 alone and in combination with anticancer agents in participants with selected advanced solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2024
Typical duration for phase_1
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
October 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 11, 2026
March 1, 2026
3.2 years
September 11, 2024
May 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including findings from abnormal laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined Adverse Event of Clinical Interest (AECI) criteria.
From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Approximately 1 year
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C477
RDFE of BG-C477 monotherapy will be determined based upon available data.
Approximately 1 year
Phase 1b: Overall Response Rate (ORR)
ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Approximately 2 years
Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C477
RP2D of BG-C477 alone and in combination with anticancer agents will be determined based upon available data.
Approximately 2 years
Secondary Outcomes (13)
Phase 1a: ORR
Approximately 1 year
Phase 1a and 1b: Duration of Response (DOR)
Approximately 2 years
Phase 1a and 1b: Disease Control Rate (DCR)
Approximately 2 years
Phase 1b: Progression-Free Survival (PFS)
Approximately 2 years
Phase 1b: Number of Participants with AEs and SAEs
From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
- +8 more secondary outcomes
Study Arms (4)
Phase 1a: BG-C477 Monotherapy Dose Escalation
EXPERIMENTALSequential cohorts of increasing dose levels of BG-C477 will be evaluated as monotherapy.
Phase 1a: BG-C477 Monotherapy Safety Expansion
EXPERIMENTALSelected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in monotherapy.
Phase 1b Part A: BG-C477 Monotherapy Expansion and Dose Optimization
EXPERIMENTALParticipants with selected advanced solid tumors will be evaluated at different dose levels of RDFEs identified in Phase 1a.
Phase 1b Part B: Combination Therapy Expansion
EXPERIMENTALSequential cohorts of increasing dose levels of BG-C477 will be evaluated in combination with anticancer agents, including chemotherapy or tislelizumab.
Interventions
Administered intravenously.
Administered in accordance with relevant local guidelines and/or prescribing information.
Administered intravenously.
Eligibility Criteria
You may qualify if:
- Participants must sign the informed consent form (ICF) and be capable of giving written informed consent
- Participants must consent to provide an archival tumor tissue sample or a fresh baseline biopsy
- Phase 1a (Dose Escalation): Histologically confirmed advanced, metastatic, or unresectable solid tumors, that 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
- Phase 1b (Dose Expansion) Part A: Histologically confirmed advanced or metastatic select solid tumors that were previously treated with and progressed from at least 1 line of standard systemic therapy
- Phase 1b (Dose Expansion) Part B: Histologically confirmed advanced or metastatic select solid tumors who have previously received 0 or 1 line of systemic therapy for advanced disease
- ≥ 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, for ≥ 6 months after the last dose of chemotherapy, and for ≥ 4 months after the last dose of tislelizumab,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, for ≥ 3 months after chemotherapy, and for ≥ 4 months after the last dose of tislelizumab, whichever comes later.
You may not qualify if:
- Prior treatment with any carcinoembryonic antigen (CEA)-targeted ADCs or ADCs containing topoisomerase 1 (TOP1) inhibitor as payload
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (41)
City of Hope Phoenix Cancer Center
Goodyear, Arizona, 85338, United States
City of Hope National Medical Center
Duarte, California, 91010-3012, United States
Yale University, Yale Cancer Center
New Haven, Connecticut, 06520-8028, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205-2003, United States
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, 07601-2191, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Texas Oncology Longview
Longview, Texas, 75601, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148, Australia
Northern Beaches Hospital
Frenchs Forest, New South Wales, NSW 2086, Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland, QLD 4575, Australia
Cancer Research South Australia
Adelaide, South Australia, SA 5000, Australia
The Alfred Hospital
Melbourne, Victoria, VIC 3004, Australia
One Clinical Research
Nedlands, Western Australia, WA 6009, Australia
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning, Guangxi, 530201, China
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, 154004, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, 332000, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Jining No1 Peoples Hospital East Branch
Jining, Shandong, 272002, China
Linyi Peoples Hospital Beicheng Branch
Linyi, Shandong, 276005, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650100, China
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou, Zhejiang, 310002, China
Taizhou Hospital of Zhejiang Province (East)
Taizhou, Zhejiang, 317004, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191, Japan
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, 135-8550, Japan
Auckland City Hospital
Auckland, 1023, New Zealand
Siriraj Hospital
Bangkok, 10700, Thailand
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2024
First Posted
September 19, 2024
Study Start
October 3, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
May 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.