A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC

This study is a Phase I/II open-label, multi-center study to evaluate the safety, tolerability, PK, and an anti-tumor activity of JIN-A02, a 4th generation EGFR-TKI agent for oral administration, in EGFR mutant-positive, advanced NSCLC subjects who showed disease progression after receiving standard anticancer therapy, including approved EGFR-TKI therapy and/or no more than a single platinum-based anticancer chemotherapy. In Part A of the study, dose escalation is carried out where MTD is evaluated using Bayesian Optimal Interval (BOIN) design in subjects with advanced NSCLC harboring EGFR-mut

Trial Details

NCT ID
NCT05394831
Phase
PHASE1 / PHASE2
Sponsor
J Ints Bio
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • JIN-A02
Locations (sample)
  • Orange, California, United States|33.78779,-117.85311
  • Goyang-si, Gyeonggi-do, South Korea|37.65639,126.835
  • Cheongju-si, North Chungcheong, South Korea|36.63722,127.48972
  • Seoul, South Korea|37.566,126.9784
  • Seoul, South Korea|37.566,126.9784

Key Eligibility Criteria

  • Subjects age 18 or above (19 or above for South Korea)
  • Subjects with pathologically confirmed and finally diagnosed advanced and/or metastatic NSCLC with active EGFR mutant
  • Subjects who show disease progression after receiving standard anticancer therapy, including approved EGFR-TKI therapeutic and/or up to 1 time of p…
  • Subjects with a test result of locally confirmed EGFR mutant obtained through a test method approved by the sponsor using either a tumor tissue and…

For full eligibility, visit ClinicalTrials.gov.

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