A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC
Recruiting now · Phase 1/Phase 2
Conditions studied: EGFR Mutant Advanced Non-small Cell Lung Cancer
In brief
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-mutation of C797S or T790M. In Part B, dose exploration is carried out to further evaluate the safety of JIN-A02 and to determine the RP2D using 2 preliminary effective dose levels and with the help of a safety review committee (SRC) in advanced NSCLC subjects harboring EGFR mutant C797S or T790M. In Part C dose expansion study, subjects with EGFR mutant who show disease progression after receiving standard anticancer therapy, including approved EGFR-TKI therapy with activity against T790M such as Osimertinib and/or no more than one platinum-based anticancer chemotherapy, are divided into 5 different cohorts based on the EGFR mutation and the anti-tumor activity of JIN-A02 is evaluated. Before enrollment in the study, the EGFR mutant profile is determined using either tumor tissue and/or plasma ctDNA. The profile is determined locally through a test method approved by the sponsor. The sponsor reviews and approves each potential subject for enrollment. Study eligibility evaluation will utilize local test(s).
Key facts
- Study ID
- NCT05394831
- Run by
- J Ints Bio
- People needed
- 150
- Starts
- 2023-07-30
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2025-05-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Chungbuk National University Hospital — Cheongju-si, North Chungcheong, South Korea (enrolling)
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (enrolling)
- The Catholic University, St. Vincent's Hospital — Suwon, South Korea (enrolling)
- National Cancer Center — Goyang-si, Gyeonggi-do, South Korea (enrolling)
- Asan Medical Center — Seoul, South Korea (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- Faculty of Medicine Ramathibodi Hospital, Mahidol University — Ratchathewi, Bangkok, Thailand
- Seoul National University Hospital — Seoul, South Korea
- The Catholic University, St. Mary's Hospital — Seoul, South Korea
- Chao Family Comprehensive Cancer Center, University of California Irvine Healthcare — Orange, California, United States
Full record on ClinicalTrials.gov
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