A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer

Launched by BEIGENE · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BG-60366 for adults with a specific type of lung cancer known as non-small cell lung cancer (NSCLC) that has a mutation in the epidermal growth factor receptor (EGFR). This mutation can make the cancer harder to treat, and BG-60366 is designed to target and help break down this mutated protein. The trial is being conducted in two parts to assess how safe the treatment is and how well it works for patients with advanced or spreading lung cancer who have not responded to previous treatments.

To be eligible for this trial, participants need to have a confirmed diagnosis of NSCLC with an EGFR mutation and have experienced disease progression after taking certain standard treatments. They should also have at least one measurable tumor, and their general health needs to be stable. Throughout the trial, participants will receive close monitoring and may experience some side effects, as is common with new treatments. This study is currently looking for participants, and it aims to find effective options for patients facing challenging lung cancer cases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Histologically or cytologically confirmed diagnosis of NSCLC, carrying an EGFR activating mutation prior to receiving standard EGFR-tyrosine kinase inhibitor (EGFR-TKI)
• * Phase 1a general inclusion criteria:
• • Disease progression on prior third-generation EGFR-TKI for advanced or metastatic disease, and either progressed or ineligible for currently available standard-of-care treatment (eg, platinum-based chemotherapy) after EGFR-TKI treatment
• • Phase 1a safety expansion
• • Documentation of EGFR resistance mutations (ie, C797s)
• • At least ≥ 1 evaluable lesion (for Phase 1a Dose Escalation) or at least ≥ 1 measurable lesion (for Phase 1a Safety Expansion or Phase 1b Dose Expansion) per RECIST v1.1
• • EGFR resistance mutations may be detected locally either from tumor tissue or circulating tumor DNA (ctDNA) in blood, and samples used for detection of resistance mutations must be collected after progression on the most recent systemic antitumor treatment
• • Adequate organ function
• • Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
• Exclusion Criteria:
• • Any previous histologic or cytologic evidence of small cell or combined small cell/non-small cell disease in the archival tumor tissue or tumor biopsy before enrollment
• • Symptomatic spinal cord compression
• • Brain metastases which are symptomatic and/or requiring emergency treatment (eg, starting steroid, or stereotactic radiation/whole-brain radiation within 2 weeks before first dose of study drug)
• • Prior treatment with fourth-generation EGFR-TKI, other CDAC/proteolysis-targeting chimeras (PROTAC) compounds targeting EGFR mutations, or other drugs with the mechanism of action specifically targeting EGFR resistance mutations (eg, C797X) (except for the first- to third-generation EGFR-TKIs)
• • Any history of interstitial lung disease (ILD) or ≥ Grade 2 noninfectious pneumonitis ≤ 2 years before the first dose of study drug, or has current ILD/noninfectious pneumonitis, or where suspected active ILD/noninfectious pneumonitis cannot be ruled out by imaging during screening
• • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
• • Note: Other protocol defined Inclusion/Exclusion criteria may apply.