Advanced Solid Tumors
Conditions
Keywords
BG-C477, advanced solid tumors, CEA ADC
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.
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
DRUGBG-C477
Administered intravenously.
DRUGTislelizumab
Administered intravenously.
DRUGChemotherapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Sponsors
BeOne Medicines
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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) | 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 | Approximately 1 year | RDFE of BG-C477 monotherapy will be determined based upon available data. |
| Phase 1b: Overall Response Rate (ORR) | 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 | Approximately 2 years | RP2D of BG-C477 alone and in combination with anticancer agents will be determined based upon available data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a: ORR | 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) | 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) | 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) | 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 | 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 | 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 | — |
| Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs) against BG-C477 | Approximately 2 years | — |
Countries
Australia, China, Japan, Malaysia, New Zealand, South Korea, Thailand, United States
Contacts
CONTACTStudy Director
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed