CFT8919
[THERAPEUTIC_PROFILE]
NSCLC
A small molecule protein degrader
[CLINICAL_TRIALS_REGISTRY]
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of CFT8919 Capsules in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC).
[INVESTIGATORS_&_FACILITY_ROSTER]
[PRIMARY_SUCCESS_ENDPOINTS]
Analysis Window: up to 104 weeks
Analysis Window: Determined at the end of the dose-escalation phase，an average of 1 year
Analysis Window: Determined at the end of the dose-expansion，an average of 2 years
[SECONDARY_SUCCESS_ENDPOINTS]
Analysis Window: At the end of Cycle 1 (each cycle is 28 days)
Analysis Window: From the start of treatment until 28 days after the last dose
Analysis Window: Up to approximately 30 months
Analysis Window: Up to approximately 30 months.
Analysis Window: Up to approximately 30 months
[COHORT_ARMS_ARCHITECTURE_BREAKDOWN]
Intervention Name: CFT8919 capsule Intervention Type: Drug Intervention Description: Participants will receive CFT8919 at different dose levels in a "3+3" dose-escalation design, starting from 150 mg BID, increasing to 300 mg, 600 mg, and up to 900 mg BID.
After the MTD is determined in Phase Ia, participants will receive CFT8919 at the recommended Phase II dose (RP2D). The primary objective is to further evaluate the safety and preliminary antitumor activity of the drug at the RP2D
Participants will be enrolled based on their EGFR mutation status into separate cohorts. Each cohort will receive CFT8919 at the RP2D to evaluate its efficacy, safety, and pharmacokinetic profile in specific EGFR mutation populations, including those with L858R and other EGFR-resistant mutations after EGFR-TKI treatment.
[DOSING_&_INTERVENTION_SPECIFICITIES]
Phase 1a，enrolled, eligible patients receive CFT8919 150-900mg twice daily.
Phase 1b，enrolled, eligible patients receive CFT8919 RP2D twice daily.
Phase 1c，enrolled, eligible patients receive CFT8919 RP2D twice daily.