Active — Not RecruitingPhase 1

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

United States33 participantsStarted 2024-12-05

Plain-language summary

This is an open-label, multicenter, Phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-60366, a highly potent, selective EGFR-mutation targeted Chimeric Degradation Activation Compound (CDAC). BG-60366 is designed to degrade mutant EGFR, which is a common cause for Non-Small Cell Lung Cancer (NSCLC). This study will evaluate how well BG-60366 works in participants with advanced or metastatic EGFR-mutant NSCLC. The study will be conducted in 2 parts: 1) Phase 1a Dose Escalation and Safety Expansion, and 2) Phase 1b Dose Expansion.

Who can participate

Age range18 Years

SexALL

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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 fir…

What they're measuring

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 18 months)

Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)

Timeframe: Approximately 1 month

Phase 1a: Recommended dose(s) for expansion (RDFE) of BG-60366

Timeframe: Approximately 18 months

Phase 1b: Number of Participants with Adverse Events and Serious Adverse Events

Timeframe: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 24 months)

Phase 1b: Overall Response Rate (ORR)

Timeframe: Approximately 24 months

Trial details

NCT IDNCT06685718

SponsorBeOne Medicines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05-15

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