Advanced Solid Tumor, Solid Tumors
Conditions
Brief summary
This study is a first-in-human (FIH), Phase 1a/1b study of BG-C0902, a fully humanized anti-epidermal growth factor receptor (EGFR) and anti-mesenchymal-epithelial transition (MET) antibody, conjugated via an enzymatically cleavable linker to a topoisomerase 1 (TOPO1) inhibitor payload. The study aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C0902 in participants with advanced solid tumors. The study will be conducted in 2 phases: Phase 1a (dose escalation and safety expansion) and Phase 1b (dose expansion).
Detailed description
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-C0902
Administered by intravenous infusion
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 with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors not amenable to therapy with curative intent or for whom treatment is not available or not tolerated. * Participants must be able to provide archival tissue formalin-fixed paraffin-embedded (FFPE) block containing tumor tissue or approximately 10 to 15 freshly cut unstained FFPE slides) or recently obtained fresh tumor biopsy samples at screening. * Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1, as assessed ≤ 14 days before the first dose of study drug. * Adequate bone marrow and organ function as indicated by the following laboratory values ≤ 14 days before the first dose of study drug * Female participants of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 7 months after the last dose of study drug. They must also have a negative serum pregnancy test result ≤ 3 days before the first dose of study drug. * 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 ≥ 4 months after the last dose of study drug.
Exclusion criteria
* History of severe allergic reactions or hypersensitivity to BG-T187 or other monoclonal antibodies, or to the active ingredient and excipients of the study drug or camptothecins. * For Phase 1a Part B Safety Expansion and Phase 1b only: Prior treatment with an EGFR-targeting ADC or mesenchymal-epithelial transition (MET)-targeting antibody-drug conjugate (ADC), or any ADC with topoisomerase I (TOPO1) inhibitor payload. * Active leptomeningeal disease or uncontrolled, untreated brain metastasis. Participants with a history of treated and, at the time of screening, stable central nervous system (CNS) metastases are eligible, provided they meet all the following: 1. Brain imaging at screening shows no evidence of interim progression, is clinically stable for ≥ 4 weeks, and has no evidence of new brain metastases 2. Have measurable disease and/or evaluable disease outside CNS 3. No ongoing requirement for corticosteroids as therapy for CNS disease; off corticosteroids ≥ 14 days before dosing with study drug; anticonvulsants at a stable dose are allowed 4. No stereotactic radiation or whole-brain radiation ≤ 14 days before the first dose of study drug * History of interstitial lung disease (ILD), or ≥ Grade 2 noninfectious pneumonitis ≤ 2 years before the first dose of the study drug, or has current ILD/noninfectious pneumonitis, or where suspected active ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening. * Participants with active or chronic corneal disorder, including but not limited to Sjögren's, Fuch's corneal dystrophy, history of corneal transplantation, corneal keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy. 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) | Approximately 24 Months | — |
| Phase 1a: Number of Participants with Dose Limiting Toxicities (DLTs) | Approximately 21 Days | — |
| Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0902 | Approximately 24 Months | 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) of BG-C0902 | Approximately 24 Months | RDFE of BG-C0902 will be determined based upon the MTD or MAD. |
| Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C0902 as Monotherapy | Approximately 24 Months | RP2D as determined based on safety, pharmacokinetics (PK), pharmacodynamics, preliminary antitumor activity, and other relevant data, as available. |
| Phase 1b: Overall Response Rate (ORR) | Approximately 24 Months | ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) as determined from tumor assessments by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a: ORR | Approximately 24 Months | ORR is defined as the percentage of participants with best overall response of CR or PR. as assessed by the investigator using RECIST v1.1. |
| Phase 1a and 1b: Duration of Response (DOR) | Approximately 24 Months | DOR is defined as the time from the first confirmed objective response by the investigator using RECIST v1.1 until the first documentation of disease progression after treatment initiation or death, whichever comes first. |
| Phase 1a and 1b: Disease Control Rate (DCR) | Approximately 24 Months | DCR is defined as the percentage of participants with the best overall response, of a CR, PR, and stable disease assessed by the investigator using RECIST v1.1. |
| Phase 1b: Progression-free Survival (PFS) | Approximately 24 Months | PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.1 |
| Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Approximately 24 Months | Number of participants with treatment-emergent AEs and SAEs. |
| Phase 1a and 1b: Area under the Concentration-time Curve (AUC) of BG-C0902, Total Antibody, and Payload | Two times in the first three months | — |
| Phase 1a and 1b: Maximum Observed Plasma Concentration (Cmax) of BG-C0902, Total Antibody, and Payload | Two times in the first three months | — |
| Phase 1a and 1b: Time to Maximum Concentration (Tmax) of BG-C0902, Total Antibody, and Payload | Two times in the first three months | — |
| Phase 1a and 1b: Half-life (t1/2) of BG-C0902, Total Antibody, and Payload | Two times in the first three months | — |
| Phase 1a and 1b: Volume of Distribution (Vd) of BG-C0902, Total Antibody, and Payload | Two times in the first three months | — |
| Phase 1a and 1b: Number of Participants with Anti-drug Antibodies (ADAs) to BG-C0902 | Approximately 24 Months | — |
Countries
Australia, China, United States
Contacts
CONTACTStudy Director
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed