A Study of BG-C477 in Participants With Advanced Solid Tumors
- 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.
- Short title
- A Study of BG-C477 in Participants With Advanced Solid Tumors
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-12-31
- First posted
- 2024-09-19
- Registry last updated
- 2026-08-03
- Primary completion date
- 2027-12-31
- Start date
- 2024-10-03
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- BeOne Medicines
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06596473
- ClinicalTrials.gov ID
- NCT06596473
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
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.
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
Timeframe: Approximately 1 year
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.
Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C477
Timeframe: Approximately 1 year
RDFE of BG-C477 monotherapy will be determined based upon available data.
Phase 1b: Overall Response Rate (ORR)
Timeframe: Approximately 2 years
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.
Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C477
Timeframe: Approximately 2 years
RP2D of BG-C477 alone and in combination with anticancer agents will be determined based upon available data.
Phase 1a: ORR
Timeframe: Approximately 1 year
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.
Phase 1a and 1b: Duration of Response (DOR)
Timeframe: Approximately 2 years
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.
Phase 1a and 1b: Disease Control Rate (DCR)
Timeframe: Approximately 2 years
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.
Phase 1b: Progression-Free Survival (PFS)
Timeframe: Approximately 2 years
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.
Phase 1b: Number of Participants with AEs and SAEs
Timeframe: From first dose of the study drug(s) to 30 days after the last dose (up to approximately 2 years)
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.
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-C477 antibody-drug conjugate (ADC), BG-C477 total antibody, and free payload
Timeframe: Approximately 2 months
Phase 1a and 1b: Minimum concentration (Cmin) of BG-C477
Timeframe: Approximately 2 months
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-C477
Timeframe: Approximately 2 months
Phase 1a and 1b: Area under the concentration-versus-time curve during dosing interval (AUCtau) of BG-C477
Timeframe: Approximately 2 months
Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-C477
Timeframe: Approximately 2 months
Phase 1a and 1b: Systemic clearance (CL/F) of BG-C477
Timeframe: Approximately 2 months
Phase 1a and 1b: Apparent volume of distribution at steady state (Vss) of BG-C477
Timeframe: Approximately 2 months
Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs) against BG-C477
Timeframe: Approximately 2 years
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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.
- City of Hope Phoenix Cancer CenterGoodyear, United StatesRecruiting
- City of Hope National Medical CenterDuarte, United StatesRecruiting
- University of Colorado Cancer CenterAurora, United StatesRecruiting
- Yale University Yale Cancer CenterNew Haven, United StatesRecruiting
- Osf Saint Francis Medical CenterPeoria, United StatesRecruiting
- The University of Kansas Cancer CenterWestwood, United StatesRecruiting
- John Theurer Cancer Center Hackensack University Medical CenterHackensack, United StatesRecruiting
- The University of Texas Md Anderson Cancer CenterHouston, United StatesRecruiting
- Texas Oncology LongviewLongview, United StatesRecruiting
- Blacktown Cancer and Haematology CentreBlacktown, AustraliaRecruiting
- Northern Beaches HospitalFrenchs Forest, AustraliaRecruiting
- Sunshine Coast University Private HospitalBirtinya, AustraliaRecruiting
- Cancer Research South AustraliaAdelaide, AustraliaRecruiting
- The Alfred HospitalMelbourne, AustraliaRecruiting
- One Clinical ResearchNedlands, AustraliaRecruiting
- Cancer Hospital Chinese Academy of Medical SciencesBeijing, ChinaRecruiting
- Beijing Chest Hospital, Capital Medical UniversityBeijing, ChinaRecruiting
- Chongqing University Cancer HospitalChongqing, ChinaRecruiting
- Fujian Cancer HospitalFuzhou, ChinaRecruiting
- Sun Yat Sen University Cancer CenterGuangzhou, ChinaRecruiting
- Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaRecruiting
- Guangxi Medical University Cancer Hospital Wuxiang BranchNanning, ChinaRecruiting
- Harbin Medical University Cancer HospitalHarbin, ChinaRecruiting
- Jiamusi Cancer HospitalJiamusi, ChinaRecruiting
- Henan Cancer HospitalZhengzhou, ChinaRecruiting
And 33 more, listed on the interactive page.
Other registry identifiers
- CTR20244563