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Advanced Solid TumorsPhase 1NCT06596473

A Study of BG-C477 in Participants With Advanced Solid Tumors

A Phase 1 study testing BG-C477, Tislelizumab and Chemotherapy in people with Advanced Solid Tumors, run by BeOne Medicines at 59 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
BG-C477, Tislelizumab and Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
59 sitesin 8 countries
Study dates
3 Oct 2024to 31 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

59 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Study Director contact

1.877.828.5568

clinicaltrials@beonemed.com

59 sites in 8 countries

China26 sites, 26 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Recruiting

  • Beijing Chest Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    Recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    Hangzhou, Zhejiang, 310002

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Recruiting

  • Jiamusi Cancer Hospital

    Jiamusi, Heilongjiang, 154004

    Recruiting

  • Jining No1 Peoples Hospital East Branch

    Jining, Shandong, 272002

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650100

    Recruiting

  • Linyi Peoples Hospital Beicheng Branch

    Linyi, Shandong, 276005

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

    Recruiting

  • The First Affiliated Hospital of Nanchang University Branch Xianghu

    Nanchang, Jiangxi, 332000

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Recruiting

  • Guangxi Medical University Cancer Hospital Wuxiang Branch

    Nanning, Guangxi, 530201

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Recruiting

  • Taizhou Hospital of Zhejiang Province (East)

    Taizhou, Zhejiang, 317004

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Recruiting

Other trials in China

United States10 sites, 10 recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045-2517

    Recruiting

  • City of Hope National Medical Center

    Duarte, California, 91010-3012

    Recruiting

  • City of Hope Phoenix Cancer Center

    Goodyear, Arizona, 85338

    Recruiting

  • John Theurer Cancer Center Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Recruiting

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009

    Recruiting

  • University of Mississippi Medical Center (Ummc)

    Jackson, Mississippi, 39216

    Recruiting

  • Texas Oncology Longview

    Longview, Texas, 75601

    Recruiting

  • Yale University Yale Cancer Center

    New Haven, Connecticut, 06520-8028

    Recruiting

  • Osf Saint Francis Medical Center

    Peoria, Illinois, 61637

    Recruiting

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205-2003

    Recruiting

Other trials in United States

Australia6 sites, 6 recruiting

  • Cancer Research South Australia

    Adelaide, South Australia, SA 5000

    Recruiting

  • Sunshine Coast University Private Hospital

    Birtinya, Queensland, QLD 4575

    Recruiting

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales, NSW 2148

    Recruiting

  • Northern Beaches Hospital

    Frenchs Forest, New South Wales, NSW 2086

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, VIC 3004

    Recruiting

  • One Clinical Research

    Nedlands, Western Australia, WA 6009

    Recruiting

Other trials in Australia

Malaysia5 sites, 5 recruiting

  • Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas)

    Kota Kinabalu Sabah, 88996

    Recruiting

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586

    Recruiting

  • Sarawak General Hospital

    Kuching, 93586

    Recruiting

  • Sunway Medical Centre

    Petaling Jaya, 47500

    Recruiting

  • National Cancer Institute (Institut Kanser Negara)

    Putrajaya, 62250

    Recruiting

Other trials in Malaysia

Japan4 sites, 4 recruiting

  • Tokyo Metropolitan Komagome Hospital

    Bunkyoku, Tokyo, 113-8677

    Recruiting

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

    Recruiting

  • Cancer Institute Hospital of Jfcr

    Kotoku, Tokyo, 135-8550

    Recruiting

  • Shizuoka Cancer Center

    Suntogun, Shizuoka, 411-8777

    Recruiting

Other trials in Japan

South Korea4 sites, 4 recruiting

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

    Recruiting

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

    Recruiting

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505

    Recruiting

Other trials in South Korea

Thailand3 sites, 3 recruiting

  • Siriraj Hospital

    Bangkok, 10700

    Recruiting

  • Srinagarind Hospital (Khon Kaen University)

    Muang, 40002

    Recruiting

  • King Chulalongkorn Memorial Hospital (Chulalongkorn University)

    Pathum Wan, 10330

    Recruiting

Other trials in Thailand

New Zealand1 site, 1 recruiting

  • Auckland City Hospital

    Auckland, 1023

    Recruiting

Other trials in New Zealand

About this study

Official title: 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.

Read the 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.

Being tested
BG-C477, Tislelizumab, Chemotherapy
Keywords
BG-C477, advanced solid tumors, CEA ADC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BG-C477Drug

    Administered intravenously.

  • TislelizumabDrug

    Also called BGB-A317

    Administered intravenously.

  • ChemotherapyDrug

    Administered in accordance with relevant local guidelines and/or prescribing information.

Study groups in NCT06596473
Study groupRoleWhat they receive
Phase 1a: BG-C477 Monotherapy Dose EscalationExperimentalSequential cohorts of increasing dose levels of BG-C477 will be evaluated as monotherapy.
Receives: Drug: BG-C477
Phase 1a: BG-C477 Monotherapy Safety ExpansionExperimentalSelected dose levels that have been determined to be safe in Phase 1a dose escalation will be further evaluated in monotherapy.
Receives: Drug: BG-C477
Phase 1b Part A: BG-C477 Monotherapy Expansion and Dose OptimizationExperimentalParticipants with selected advanced solid tumors will be evaluated at different dose levels of RDFEs identified in Phase 1a.
Receives: Drug: BG-C477
Phase 1b Part B: Combination Therapy ExpansionExperimentalSequential cohorts of increasing dose levels of BG-C477 will be evaluated in combination with anticancer agents, including chemotherapy or tislelizumab.
Receives: Drug: BG-C477; Drug: Tislelizumab; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)

  2. 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.

    Measured: Approximately 1 year

  3. Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C477

    RDFE of BG-C477 monotherapy will be determined based upon available data.

    Measured: Approximately 1 year

  4. 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.

    Measured: Approximately 2 years

  5. 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.

    Measured: Approximately 2 years

Secondary outcomes (13)

  1. 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.

    Measured: Approximately 1 year

  2. 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.

    Measured: Approximately 2 years

  3. 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.

    Measured: Approximately 2 years

  4. 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.

    Measured: Approximately 2 years

  5. 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.

    Measured: From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)

  6. Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-C477 antibody-drug conjugate (ADC), BG-C477 total antibody, and free payload

    Measured: Approximately 2 months

  7. Phase 1a and 1b: Minimum concentration (Cmin) of BG-C477

    Measured: Approximately 2 months

  8. Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-C477

    Measured: Approximately 2 months

  9. Phase 1a and 1b: Area under the concentration-versus-time curve during dosing interval (AUCtau) of BG-C477

    Measured: Approximately 2 months

  10. Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-C477

    Measured: Approximately 2 months

  11. Phase 1a and 1b: Systemic clearance (CL/F) of BG-C477

    Measured: Approximately 2 months

  12. Phase 1a and 1b: Apparent volume of distribution at steady state (Vss) of BG-C477

    Measured: Approximately 2 months

  13. Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs) against BG-C477

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start3 Oct 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06596473
Sponsor's protocol ID
BG-C477-101
Other IDs
CTR20244563
Status last verified
Mar 2026
First submitted
11 Sep 2024
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BG-C477, Tislelizumab and Chemotherapy in people with Advanced Solid Tumors, run by BeOne Medicines at 59 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in China, United States, Australia, Malaysia, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director (1.877.828.5568, clinicaltrials@beonemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06596473.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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Clinical Trial NCT06596473 | AzTrials