Advanced Solid Tumor
Conditions
Interventions
- Drug: BG-C137
- Administered intravenously
- Drug: Anticancer Agents
- Administered intravenously or orally
Sponsors
Kudo Asako
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed advanced or metastatic solid tumors. - Life expectancy of >= 3 months. - 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 - 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. - >= 1 measurable lesion per RECIST v1.1. - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. - Adequate organ function as determined per protocol.
Exclusion criteria
Exclusion criteria: - Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies. - 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. - Spinal cord compression, or active leptomeningeal disease or uncontrolled, untreated brain metastasis. - Systemic antitumor therapy (including targeted therapy and immunotherapy = 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. - 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/Exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (Time Frame: 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 (Time Frame: 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 (Time Frame: 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 (Time Frame: 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) (Time Frame: 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) | — |
Countries
Australia, China, Japan, South Korea, United States
Contacts
Public ContactFumiaki Hamano
BeOne Medicines Japan
Outcome results
None listed