Actively Recruiting
A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC
Led by J Ints Bio · Updated on 2025-05-16
150
Participants Needed
10
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (19 or older in South Korea)
- Diagnosed with advanced or metastatic NSCLC with active EGFR mutation
- Disease progression after approved EGFR-TKI therapy and/or up to one platinum-based chemotherapy
- Confirmed EGFR mutation by approved local testing of tumor tissue or plasma ctDNA
- For Part A and B: positive for EGFR C797S or T790M mutations
- For Part C: assigned to cohorts based on EGFR mutation types including C797S, T790M, stable brain metastasis, or other EGFR mutations
- At least one measurable lesion not previously treated with radiation (Part C)
- ECOG performance status of 0 or 1
- Recovery from acute effects of prior therapy to baseline or CTCAE grade 1 or less, with some chronic conditions allowed
- Adequate bone marrow and organ function including hemoglobin ≥ 9.0 g/dL, platelets ≥ 75 x 10^9/L, neutrophils ≥ 1.0 x 10^9/L, bilirubin ≤ 1.5 x ULN (≤ 3.0 for Gilbert syndrome), AST/ALT ≤ 3.0 x ULN (≤ 5.0 if hepatic metastasis), and creatinine clearance ≥ 60 mL/min/1.73m2
- Negative pregnancy test for women with childbearing potential before screening and first dose
- Use of effective contraception for women and men with partners of childbearing potential during treatment and 90 days after last dose
- No breastfeeding during study and 90 days after last dose
You will not qualify if you...
- NSCLC with mixed squamous cell histology or histological transformation to small cell lung cancer
- For Parts A, B, and Cohort 4 of Part C: requiring steroid escalation within 28 days for CNS metastasis or disease treatment; leptomeningeal disease unless stable and asymptomatic after treatment
- For Part C except Cohort 4: absence of CNS metastasis
- Recent treatments before first dose: EGFR-TKI within 7 days, systemic anticancer therapy within 14 days or 5 half-lives, limited radiation within 7-14 days, immunotherapy within 28 days
- Recovery not complete from major surgery or treatment side effects within 28 days
- Significant cardiac conditions including QTcF > 470 ms, uncontrolled arrhythmias, uncontrolled hypertension, recent heart failure or myocardial infarction
- Active malignancy other than treated skin cancers within 2 years unless cured
- History or evidence of interstitial lung disease or pneumonia needing steroids
- Inability to swallow or absorb oral medication or significant gastrointestinal disorder
- Active infections such as HIV, hepatitis B or C, tuberculosis, or symptomatic COVID-19
- Known allergy to study drug or related substances
- History of drug abuse or unstable medical, mental, or social conditions
- Inability to comply with study protocol as judged by investigator
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Chao Family Comprehensive Cancer Center, University of California Irvine Healthcare
Orange, California, United States, 92868
Active, Not Recruiting
2
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 03722
Actively Recruiting
3
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea, 28644
Actively Recruiting
4
Seoul National University Hospital
Seoul, South Korea, 03080
Withdrawn
5
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
6
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
7
The Catholic University, St. Mary's Hospital
Seoul, South Korea, 06591
Not Yet Recruiting
8
Yonsei University Health System, Severance Hospital
Seoul, South Korea, 10400
Actively Recruiting
9
The Catholic University, St. Vincent's Hospital
Suwon, South Korea, 16247
Actively Recruiting
10
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Ratchathewi, Bangkok, Thailand, 10400
Not Yet Recruiting
Research Team
G
Gayeon Yeom
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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