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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 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. The trial reports 10 study locations across 5 states.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05394831
The ClinicalTrials.gov registry entry for NCT05394831 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is J Ints Bio, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 10 study locations spanning 5 distinct geographic areas - top geographies include 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.
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