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Recruiting NCT06596473

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

Phase I Interventional Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BG-C477, Tislelizumab, Chemotherapy.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, China, Japan, Malaysia +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Interventions

  • Drug BG-C477
    Administered intravenously.
  • Drug Tislelizumab
    Administered intravenously.
  • Drug Chemotherapy
    Administered in accordance with relevant local guidelines and/or prescribing information.

Primary outcome measures

  • 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)]
  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) [Time frame: Approximately 1 year]
  • Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C477 [Time frame: Approximately 1 year]
  • Phase 1b: Overall Response Rate (ORR) [Time frame: Approximately 2 years]
  • Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C477 [Time frame: Approximately 2 years]
Secondary outcome measures (12)
  • Phase 1a: ORR [Time frame: Approximately 1 year]
  • Phase 1a and 1b: Duration of Response (DOR) [Time frame: Approximately 2 years]
  • Phase 1a and 1b: Disease Control Rate (DCR) [Time frame: Approximately 2 years]
  • Phase 1b: Progression-Free Survival (PFS) [Time frame: Approximately 2 years]
  • Phase 1b: Number of Participants with AEs and SAEs [Time frame: 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 [Time frame: Approximately 2 months]
  • Phase 1a and 1b: Minimum concentration (Cmin) of BG-C477 [Time frame: Approximately 2 months]
  • Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-C477 [Time frame: Approximately 2 months]
  • Phase 1a and 1b: Area under the concentration-versus-time curve during dosing interval (AUCtau) of BG-C477 [Time frame: Approximately 2 months]
  • Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-C477 [Time frame: Approximately 2 months]
  • Phase 1a and 1b: Systemic clearance (CL/F) of BG-C477 [Time frame: Approximately 2 months]
  • Phase 1a and 1b: Apparent volume of distribution at steady state (Vss) of BG-C477 [Time frame: Approximately 2 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 26 centers
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing
  • Beijing Chest Hospital, Capital Medical University — Beijing
  • Chongqing University Cancer Hospital — Chongqing
  • Fujian Cancer Hospital — Fuzhou
  • Sun Yat Sen University Cancer Center — Guangzhou
  • Nanfang Hospital, Southern Medical University — Guangzhou
  • Guangxi Medical University Cancer Hospital Wuxiang Branch — Nanning
  • Harbin Medical University Cancer Hospital — Harbin
  • … and 18 more centers
United States · 9 centers
  • City of Hope Phoenix Cancer Center — Goodyear
  • City of Hope National Medical Center — Duarte
  • University of Colorado Cancer Center — Aurora
  • Yale University Yale Cancer Center — New Haven
  • Osf Saint Francis Medical Center — Peoria
  • The University of Kansas Cancer Center — Westwood
  • John Theurer Cancer Center Hackensack University Medical Center — Hackensack
  • The University of Texas Md Anderson Cancer Center — Houston
  • … and 1 more center
Australia · 6 centers
  • Blacktown Cancer and Haematology Centre — Blacktown
  • Northern Beaches Hospital — Frenchs Forest
  • Sunshine Coast University Private Hospital — Birtinya
  • Cancer Research South Australia — Adelaide
  • The Alfred Hospital — Melbourne
  • One Clinical Research — Nedlands
Malaysia · 5 centers
  • Hospital Wanita Dan Kanak Kanak Sabah (Hospital Likas) — Kota Kinabalu Sabah
  • Hospital Kuala Lumpur — Kuala Lumpur
  • Sarawak General Hospital — Kuching
  • Sunway Medical Centre — Petaling Jaya
  • National Cancer Institute (Institut Kanser Negara) — Putrajaya
Japan · 4 centers
  • Kansai Medical University Hospital — Hirakata
  • Shizuoka Cancer Center — Suntogun
  • Tokyo Metropolitan Komagome Hospital — Bunkyoku
  • Cancer Institute Hospital of Jfcr — Kotoku
South Korea · 4 centers
  • Seoul National University Bundang Hospital — Seongnam-si
  • Samsung Medical Center — GangnamGu
  • Severance Hospital Yonsei University Health System — SeodaemunGu
  • Asan Medical Center — SongpaGu
Thailand · 3 centers
  • Siriraj Hospital — Bangkok
  • Srinagarind Hospital (Khon Kaen University) — Muang
  • King Chulalongkorn Memorial Hospital (Chulalongkorn University) — Pathum Wan
New Zealand · 1 center
  • Auckland City Hospital — Auckland

Identifiers

NCT: NCT06596473 · BG-C477-101 · CTR20244563

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗