Advanced Solid Tumor
Conditions
Keywords
BG-C137, Advanced Solid Tumor, First-in-human, FGFR2b, ADC, Fibroblast growth factor receptor 2b
Brief summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C137 alone and in combination with anticancer agents in participants with advanced solid tumors. The study will be conducted in two phases: Phase 1a (Monotherapy Dose Escalation, and Safety Expansion; Combination Dose Confirmation 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-C137
Administered intravenously
Administered intravenously or orally
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
1. Histologically or cytologically confirmed advanced or metastatic solid tumors. 2. Life expectancy of ≥ 3 months. 3. Prior standard systemic therapy in the advanced or metastatic setting. Dose Escalation: Participants for whom further standard treatment is not available, not tolerated or determined not appropriate based on the investigator's judgment. Combo Dose Confirmation, Combo Safety Expansion, and Dose Expansion: Participants who have received at least 1 or 2 prior lines of systemic therapy, which included a fluoropyrimidine and/or a platinum in the advanced or metastatic setting 4. Tumors with FGFR2b expression/ or FGFR2 gene amplification. Participants must provide agreement for collection of archival tissue or recently obtained fresh tumor biopsy for central evaluation of FGFR2b expression levels and other biomarker assessments. 5. ≥ 1 measurable lesion per RECIST v1.1. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 7. Adequate organ function as determined per protocol.
Exclusion criteria
1. Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies. 2. Active or chronic corneal disorder, 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. 3. Spinal cord compression, or active leptomeningeal disease or uncontrolled, untreated brain metastasis. 4. Systemic antitumor therapy (including targeted therapy and immunotherapy ≤ 14 days, ≤ 28 days for immuno- oncological antibody, ≤ 14 days or 5 half-lives \[whichever is shorter\] for chemotherapy, ADCs, or investigational therapy) before first dose of study drug(s). 5. Toxicities due to prior therapy that have not recovered. 6. Any malignancy ≤ 2 years before 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. 7. History of interstitial lung disease (ILD), noninfectious pneumonitis, oxygen saturation at rest \< 92%, or requirement for supplemental oxygen at baseline. 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) | Up to approximately 2 years | Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version (NCI CTCAE 5.0)), including AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria and AEs meeting protocol-defined adverse event of clinical interest (AECIs) |
| Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C137 | Up to approximately 2 years | The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to a target toxicity rate, or the highest dose administered, respectively. |
| Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-C137 as monotherapy and in combination with anticancer agents | Up to approximately 2 years | RDFE(s) is determined based on relevant data, as available |
| Phase 1b: The recommended Phase 2 dose (RP2D) of BG-C137 | Up to approximately 2 years | The RP2D of BG-C137 monotherapy will be determined based on relevant data, as available |
| Phase 1b: Overall Response Rate (ORR) | Up to approximately 2 years | ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase 1a: ORR | Up to approximately 2 years | ORR is defined as the percentage of participants with CR or PR, as determined by RECIST v1.1 |
| Phase 1a and 1b: Disease Control Rate (DCR) | Up to approximately 2 years | DCR is defined as the percentage of participants with best overall response of a CR, PR, and stable disease, as assessed by RECIST v1.1 |
| Phase 1a and 1b: Duration of Response (DOR) | Up to approximately 2 years | DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of progression or death, whichever comes first, as assessed using RECIST v1.1 |
| Phase 1b: Progression Free Survival (PFS) | Up to approximately 2 years | PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of progressive disease assessed using RECIST v1.1 or death, whichever occurs first |
| Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to approximately 2 years | Number of participants with AEs and SAEs as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version (NCI CTCAE 5.0), and AEs meeting protocol-defined adverse event of clinical interest (AECI)s. |
| Phase 1a: Plasma concentrations of BG-C137 analytes | Up to approximately 1 year; at the end of treatment (maximum of 2 years) and at the first safety follow-up visit (30 days after last dose) | — |
| Phase 1b: Plasma concentrations of BGB-C137 analytes | Up to approximately 1 year; at the end of treatment (maximum of 2 years) and at the first safety follow-up visit (30 days after last dose) | — |
| Phase 1a: Maximum observed plasma concentration (Cmax) of BGB-C137 analytes | Twice in the first 3 months | — |
| Phase 1a: Time to reach maximum observed plasma concentration (Tmax) of BGB-C137 analytes | Twice in the first 3 months | — |
| Phase 1a: Minimum Observed Plasma Concentration (Ctrough) Of BGB-C137 analytes | Twice in the first 3 months | — |
| Phase 1a: Area Under the Plasma Concentration-time Curve (AUC) of BGB-C137 analytes | Twice in the first 3 months | — |
| Phase 1a: Terminal Half-Life (t1/2) of BGB-C137 analytes | Twice in the first 3 months | — |
| Phase 1a and 1b: Incidence of Antidrug Antibodies (ADAs) to BGB-C137 | Up to approximately 2 years | — |
Countries
Australia, China, South Korea, United States
Contacts
CONTACTStudy Director
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed