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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: Tislelizumab; Drug: Chemotherapy; Drug: BG-C477

Detailed Description

This new study will check how safe and helpful a potential anticancer drug called BG-C477 is. This drug will be tested by itself or combined with other anticancer agents. The purpose of this study is to test if BG-C477 is safe and if it works in people with your disease when it is given on its own and in combination with other anticancer agents.

Note: Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 1.877.828.5568; Email: clinicaltrials@beonemed.com

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, NSW 2148
      • Recruiting
      • Blacktown Cancer and Haematology Centre
    • Frenchs Forest, New South Wales, Australia, NSW 2086
      • Recruiting
      • Northern Beaches Hospital
  • Queensland
    • Birtinya, Queensland, Australia, QLD 4575
      • Recruiting
      • Sunshine Coast University Private Hospital
  • South Australia
    • Adelaide, South Australia, Australia, SA 5000
      • Recruiting
      • Cancer Research South Australia
  • Victoria
    • Melbourne, Victoria, Australia, VIC 3004
      • Recruiting
      • The Alfred Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, WA 6009
      • Recruiting
      • One Clinical Research
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
    • Beijing, Beijing Municipality, China, 101149
      • Recruiting
      • Beijing Chest Hospital, Capital Medical University
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Recruiting
      • Chongqing University Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat Sen University Cancer Center
  • Guangxi
    • Nanning, Guangxi, China, 530201
      • Recruiting
      • Guangxi Medical University Cancer Hospital Wuxiang Branch
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • Harbin Medical University Cancer Hospital
    • Jiamusi, Heilongjiang, China, 154004
      • Recruiting
      • Jiamusi Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Recruiting
      • Hubei Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Province Hospital
    • Suzhou, Jiangsu, China, 215006
      • Recruiting
      • The First Affiliated Hospital of Soochow University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Recruiting
      • Jiangxi Cancer Hospital
    • Nanchang, Jiangxi, China, 332000
      • Recruiting
      • The First Affiliated Hospital of Nanchang University Branch Xianghu
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • Recruiting
      • The First Hospital of China Medical University
  • Shandong
    • Jining, Shandong, China, 272002
      • Recruiting
      • Jining No1 Peoples Hospital East Branch
    • Linyi, Shandong, China, 276005
      • Recruiting
      • Linyi Peoples Hospital Beicheng Branch
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital, Sichuan University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650100
      • Recruiting
      • Yunnan Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310002
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
    • Taizhou, Zhejiang, China, 317004
      • Recruiting
      • Taizhou Hospital of Zhejiang Province (East)
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
• Japan
  • Osaka
    • Hirakata, Osaka, Japan, 573-1191
      • Recruiting
      • Kansai Medical University Hospital
  • Tokyo
    • Kotoku, Tokyo, Japan, 135-8550
      • Recruiting
      • Cancer Institute Hospital of Jfcr
• Malaysia
  • Kota Kinabalu Sabah, Malaysia, 88996
    • Recruiting
    • Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)
  • Kuala Lumpur, Malaysia, 50586
    • Recruiting
    • Hospital Kuala Lumpur
  • Kuching, Malaysia, 93586
    • Recruiting
    • Sarawak General Hospital
  • Petaling Jaya, Malaysia, 47500
    • Recruiting
    • Sunway Medical Centre
  • Putrajaya, Malaysia, 62250
    • Recruiting
    • National Cancer Institute (Institut Kanser Negara)
• New Zealand
  • Auckland, New Zealand, 1023
    • Recruiting
    • Auckland City Hospital
• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Siriraj Hospital
  • Muang, Thailand, 40002
    • Recruiting
    • Srinagarind Hospital (Khon Kaen University)
  • Pathum Wan, Thailand, 10330
    • Recruiting
    • King Chulalongkorn Memorial Hospital (Chulalongkorn University)
• United States
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Recruiting
      • City of Hope Phoenix Cancer Center
  • California
    • Duarte, California, United States, 91010-3012
      • Recruiting
      • City of Hope National Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045-2517
      • Recruiting
      • University of Colorado Cancer Center
  • Connecticut
    • New Haven, Connecticut, United States, 06520-8028
      • Recruiting
      • Yale University Yale Cancer Center
  • Illinois
    • Peoria, Illinois, United States, 61637
      • Recruiting
      • OSF Saint Francis Medical Center
  • Kansas
    • Westwood, Kansas, United States, 66205-2003
      • Recruiting
      • The University of Kansas Cancer Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • John Theurer Cancer Center Hackensack University Medical Center
  • Texas
    • Houston, Texas, United States, 77030-4009
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
    • Longview, Texas, United States, 75601
      • Recruiting
      • Texas Oncology Longview

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a: BG-C477 Monotherapy Dose Escalation; Sequential cohorts of increasing dose levels of BG-C477 will be evaluated as monotherapy.	Drug: BG-C477; Administered intravenously.
Experimental: 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.	Drug: BG-C477; Administered intravenously.
Experimental: Phase 1b Part A: BG-C477 Monotherapy Expansion and Dose Optimization; Participants with selected advanced solid tumors will be evaluated at different dose levels of RDFEs identified in Phase 1a.	Drug: BG-C477; Administered intravenously.
Experimental: Phase 1b Part B: Combination Therapy Expansion; Sequential cohorts of increasing dose levels of BG-C477 will be evaluated in combination with anticancer agents, including chemotherapy or tislelizumab.	Drug: Tislelizumab; Administered intravenously.; Other Names: BGB-A317; Drug: Chemotherapy; Administered in accordance with relevant local guidelines and/or prescribing information.; Drug: BG-C477; Administered intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: ORR	ORR is defined as the percentage of participants with best overall response of CR or PR, as assessed by the investigator per RECIST v1.1.	Approximately 1 year
Phase 1a and 1b: Duration of Response (DOR)	DOR is defined as the time from the first determination of an objective response until first documentation of disease progression or death due to any cause, whichever occurs first, as assessed by the investigator per RECIST Version 1.1.	Approximately 2 years
Phase 1a and 1b: Disease Control Rate (DCR)	DCR is defined as the percentage of participants who achieve best overall response of CR, PR, or stable disease, as assessed by the investigator per RECIST Version 1.1.	Approximately 2 years
Phase 1b: Progression-Free Survival (PFS)	PFS is defined as the time from the first administration of study drug(s) to the date of first documentation of disease progression or death due to any cause, whichever occurs first, as assessed by the investigator per RECIST Version 1.1.	Approximately 2 years
Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs) against BG-C477		Approximately 2 years
Phase 1b: Number of Participants with AEs and SAEs	Number of participants with AEs and SAEs, including findings from physical examinations, laboratory assessments, and that meet protocol-defined DLT criteria or protocol-defined AECI criteria.	From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-C477 antibody-drug conjugate (ADC), BG-C477 total antibody, and free payload		Approximately 2 months
Phase 1a and 1b: Minimum concentration (Cmin) of BG-C477		Approximately 2 months
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-C477		Approximately 2 months
Phase 1a and 1b: Area under the concentration-versus-time curve during dosing interval (AUCtau) of BG-C477		Approximately 2 months
Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-C477		Approximately 2 months
Phase 1a and 1b: Systemic clearance (CL/F) of BG-C477		Approximately 2 months
Phase 1a and 1b: Apparent volume of distribution at steady state (Vss) of BG-C477		Approximately 2 months

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: advanced solid tumors; BG-C477; CEA ADC
• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Drug Therapy; tislelizumab
• Other Study ID Numbers: BG-C477-101; CTR20244563 (Registry Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No