Condition: EGFR Mutant Advanced Non-small Cell Lung Cancer · Sponsor: J Ints Bio
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 spons…
This description comes directly from the study's public registry record.
Gayeon Yeom · +821027126609 · gayeon.yeom@jintsbio.com
Always discuss trial participation with your own doctor first.
| Chao Family Comprehensive Cancer Center, University of California Irvine Healthcare | Orange, California, United States | Active Not Recruiting |
| National Cancer Center | Goyang-si, Gyeonggi-do, South Korea | Recruiting |
| Chungbuk National University Hospital | Cheongju-si, North Chungcheong, South Korea | Recruiting |
| Seoul National University Hospital | Seoul, South Korea | Withdrawn |
| Asan Medical Center | Seoul, South Korea | Recruiting |
| Samsung Medical Center | Seoul, South Korea | Recruiting |
| The Catholic University, St. Mary's Hospital | Seoul, South Korea | Not Yet Recruiting |
| Yonsei University Health System, Severance Hospital | Seoul, South Korea | Recruiting |
| The Catholic University, St. Vincent's Hospital | Suwon, South Korea | Recruiting |
| Faculty of Medicine Ramathibodi Hospital, Mahidol University | Ratchathewi, Bangkok, Thailand | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT05394831