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NCT05394831 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC
A Phase 1 study of EGFR Mutant Advanced Non-small Cell Lung Cancer, sponsored by J Ints Bio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
- 10
- Study locations
NCT05394831: Recruiting Phase 1 study of EGFR Mutant Advanced Non-small Cell Lung Cancer, sponsored by J Ints Bio.
NCT05394831 is a Phase 1 study of EGFR Mutant Advanced Non-small Cell Lung Cancer that is actively recruiting participants, run by J Ints Bio. The registered enrollment target is 150 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (150% higher). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05394831, a Phase 1 study of EGFR Mutant Advanced Non-small Cell Lung Cancer, is actively recruiting participants, sponsored by J Ints Bio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
- 10
- Study locations
Study Summary
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).
Primary Outcome
In the Part A dose escalation study, MTD is evaluated in DLT Set. When the study ends according to the BOIN design, the DLT rate per dose level is estimated as posterior probability based on the beta-binomial model and 95% CI is presented. The dose level at which the estimated DLT rate is closest to the target toxicity rate 0.3 is selected as MTD. If two or more dose levels are selected at a rate lower than 0.3, a higher one is selected as MTD. If two or more dose levels are selected at a rate
Conditions Studied
Interventions
- DRUG JIN-A02
Study Locations (10)
Other
- Seoul National University Hospital - Seoul
- Asan Medical Center - Seoul
- Samsung Medical Center - Seoul
- The Catholic University, St. Mary's Hospital - Seoul
- Yonsei University Health System, Severance Hospital - Seoul
- The Catholic University, St. Vincent's Hospital - Suwon
California
- Chao Family Comprehensive Cancer Center, University of California Irvine Healthcare - Orange
Gyeonggi-do
- National Cancer Center - Goyang-si
North Chungcheong
- Chungbuk National University Hospital - Cheongju-si
Bangkok
- Faculty of Medicine Ramathibodi Hospital, Mahidol University - Ratchathewi
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-07-30 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
What NCT05394831 shows while recruiting
NCT05394831 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (150% higher).
The record links to 1 condition, with EGFR Mutant Advanced Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which JIN-A02 is the first listed.
NCT05394831 lists 10 locations in 5 states (Other, California, Gyeonggi-do).
Frequently Asked Questions
What is clinical trial NCT05394831 about?
NCT05394831 is a clinical study titled "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...
What is the current status of trial NCT05394831?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2023-07-30. Estimated completion is 2026-09-30.
What conditions does trial NCT05394831 study?
This clinical trial studies the following conditions: EGFR Mutant Advanced Non-small Cell Lung Cancer.
What interventions are being tested in trial NCT05394831?
The interventions under investigation include: JIN-A02 (DRUG).
Who is sponsoring clinical trial NCT05394831?
This trial is sponsored by J Ints Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05394831 being conducted?
This trial has 10 study locations across California, Gyeonggi-do, North Chungcheong, Bangkok. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05394831's enrollment target sits among peer trials
150 364th of 2000 higher than 1,620 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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