A First-in-Human Study of BG-C137, an Anti-FGFR2b Antibody Drug Conjugate, in Participants With Advanced Solid Tumors

Launched by BEIGENE · Oct 1, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment called BG-C137, which is designed to target specific cancer cells in patients with advanced solid tumors. The main goals of the study are to determine how safe the drug is, how well it works, and how it behaves in the body. Researchers are looking for participants who have been diagnosed with advanced solid tumors and have already tried other treatments. To qualify, you should have a life expectancy of at least three months and be willing to provide tissue samples from your tumor for testing.

If you decide to join this study, you will undergo monitoring to ensure your safety while receiving BG-C137. This trial is currently recruiting participants aged 65 and older, and it is open to all genders. Before enrolling, the research team will conduct tests to confirm that you meet specific health criteria, such as having a measurable tumor and adequate organ function. Being part of this trial could provide access to a new treatment option that is not yet available to the general public, but it's important to discuss with your doctor to see if this is the right choice for your situation.

Gender

ALL

Eligibility criteria

• 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. Safety Expansion and Dose Expansion: Participants who have received 1 or 2 prior lines of systemic therapy in the advanced or metastatic setting.
• • 4. 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, keratoconjuntivitis, 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/Exclusion criteria may apply.