Actively Recruiting
A Phase 1/2, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of JIN-A02 in Patients With EGFR Mutant Advanced Non-small Cell Lung Cancer
Led by J Ints Bio · Updated on 2025-05-16
150
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating JIN-A02, a fourth-generation EGFR-TKI oral medication, in people with advanced non-small cell lung cancer (NSCLC) that has specific EGFR mutations and has progressed after standard treatments. This Phase I/II open-label study focuses on assessing the safety, tolerability, pharmacokinetics, and anti-tumor activity of JIN-A02 in those who have previously received approved EGFR-TKI therapy and/or platinum-based chemotherapy. The study includes multiple parts to explore dosing and treatment effects based on mutation types. The study has three parts: Part A is a dose escalation phase using a Bayesian Optimal Interval design to find the maximum tolerated dose (MTD) in patients with EGFR mutations C797S or T790M. JIN-A02 is given once daily in 28-day cycles, with dose adjustments based on safety evaluations. Part B further explores two selected dose levels to determine the recommended Phase 2 dose (RP2D). Part C expands treatment to five cohorts defined by specific EGFR mutation profiles, monitoring anti-tumor activity using the established RP2D. Participants undergo regular assessments including safety reviews by a committee, tumor mutation testing from tissue or plasma samples, and monitoring for adverse events and dose-limiting toxicities. The study measures outcomes such as maximum tolerated dose, adverse event rates, and dose-limiting toxicities over specified timeframes. The study duration and follow-up depend on the dose-escalation, exploration, and expansion phases with ongoing data collection for safety and benefit-risk analysis.
CONDITIONS
Brief 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 above in South Korea)
- Pathologically confirmed advanced or metastatic non-small cell lung cancer with active EGFR mutation
- Disease progression after approved EGFR-TKI therapy and/or up to one platinum-based anticancer chemotherapy
- Locally confirmed EGFR mutant profile from tumor tissue or plasma ctDNA using sponsor-approved test
- For Part A and B: positive for EGFR mutant C797S or T790M
- For Part C: specific EGFR mutation cohorts as defined (C797S and T790M combinations, stable brain metastasis, or other EGFR mutations)
- At least one measurable lesion not previously radiated (Part C)
- ECOG performance status 0 or 1
- Recovery from acute effects of prior therapy to baseline or CTCAE grade 1, except certain chronic conditions
- Adequate bone marrow and organ function as defined by laboratory thresholds
- Negative pregnancy test for women of childbearing potential
- Use of effective contraception during and 90 days after treatment for sexually active participants
- No breastfeeding during study and 90 days after last dose
You will not qualify if you...
- NSCLC with mixed squamous histology or histological transformation
- Need for steroid escalation or unstable CNS metastasis in Parts A, B, and Cohort 4 (with exceptions for stable patients after treatment)
- No CNS metastasis for Part C cohorts except Cohort 4
- Recent EGFR-TKI treatment within 7 days before study drug
- Recent systemic anticancer treatment or radiation within defined timeframes before study drug
- Immunotherapy or antibody treatment within 28 days before study drug
- Recent major surgery or unresolved side effects within 28 days before study drug
- Certain cardiac dysfunctions or significant heart diseases
- Active malignancy other than treated skin cancers within 2 years
- History or evidence of interstitial lung disease or pneumonia requiring steroids
- Inability to swallow or retain oral medication or significant gastrointestinal disorders
- Uncontrolled active infections including HIV, HBV, HCV, or suspected tuberculosis
- Known sensitivity to the study drug or related substances
- History of drug abuse or unstable medical, mental, or social conditions
- Inability to follow the study protocol as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive the study drug JIN-A02 orally once daily in 28-day cycles to evaluate safety, tolerability, pharmacokinetics, and anti-tumor activity. Dose escalation and exploration are conducted to determine the optimal dose, followed by dose expansion in specific mutation cohorts.
Visits occur during each 28-day treatment cycle; exact visit schedule varies by dose cohort and study phase
Duration - Until study completion or withdrawal
Participants are monitored for safety and benefit/risk assessment after stopping treatment as determined by the investigator and study review committee.
Regular visits for safety and outcome assessments as scheduled by the study team
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
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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