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Tests treatment safety and results for EGFR Mutant Advanced Non-small Cell Lung Cancer
Official title A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC
ClinicalTrials.gov ID: NCT05394831
What this study is testing
What is JIN-A02?
JIN-A02 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for egfr mutant advanced non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people age 18 or above (19 or above for South Korea)
- people with pathologically confirmed and finally diagnosed advanced and/or metastatic NSCLC with active EGFR mutant
- people who show disease progression after receiving standard anticancer therapy, including approved EGFR-TKI therapeutic and/or up to 1 time of...
- people with a test result of locally confirmed EGFR mutant obtained through a test method approved by the sponsor using either a tumor tissue and/or...
- Part A dose escalation and Part B exploration studies: Advanced NSCLC people who are positive to EGFR mutant C797S or T790M
You likely can't join if
- NSCLC with mixed squamous cell histology and tumor with histological transformation (presence of transition from NSCLC to SCLC and epithelial...
- For Part A, B, and Cohort 4 of Part C \- people requiring steroid escalation within 28 days before start of the study due to spinal cord compression...
- For Part Part C: all Cohorts except for Cohort 4 \- people without CNS metastasis
- people who received the following treatments:
- EGFR-TKI treatment within 7 days from the first dose of the investigational product
- Systemic anticancer treatment within 14 days or 5 half-lives (whichever is the shorter period) from the first dose of the investigational product
See the full eligibility criteria
Who can join
- people age 18 or above (19 or above for South Korea)
- people with pathologically confirmed and finally diagnosed advanced and/or metastatic NSCLC with active EGFR mutant
- people who show disease progression after receiving standard anticancer therapy, including approved EGFR-TKI therapeutic and/or up to 1 time of platinum-based anticancer chemotherapy. For the Part C dose expansion...
- people with a test result of locally confirmed EGFR mutant obtained through a test method approved by the sponsor using either a tumor tissue and/or plasma ctDNA. It is preferred that samples used for analysis are...
- Part A dose escalation and Part B exploration studies: Advanced NSCLC people who are positive to EGFR mutant C797S or T790M
- Part C dose expansion study: Advanced NSCLC people who are positive for EGFR mutations C797S and T790M in Cohort 1, those who are positive for C797S and negative for T790M in Cohort 2, those who are negative for C797S...
- For Part C, people with at least 1 measurable lesion that has not been previously radiated as defined by RECIST version 1.1
- people with ECOG performance status 0 or 1
- Acute effect from a previous therapy that recovers to the baseline severity or ≤ Common Terminology Criteria for Adverse Events (CTCAE) grade 1, except for an AE not corresponding to a safety risk, as determined by the...
- Appropriate bone marrow and organ functions, including the following:
- Hemoglobin ≥ 9.0 g/dL
- Platelet ≥ 75 × 109/L
- Absolute neutrophil count ≥ 1.0 × 109/L
- Serum Total Bilirubin (TBL) ≤ 1.5 × Upper Limit of Normal Range (ULN) (≤ 3.0 x ULN for a subject with documented Gilbert syndrome)
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3.0 ×ULN, or if there is a hepatic metastasis caused by tumor, ≤ 5.0 × ULN
- \ Estimated creatinine clearance calculated using the Cockcroft-Gault formula to ≥ 60 mL/min/1.73m2
- CrCl (male) = ([140 - age] × weight (kg)) / (serum creatinine (mg/dL) × 72), CrCl (female) = CrCl (male) ×0.85
- For women with childbearing potential
- The serum pregnancy test result must be negative before screening and the first dose of the investigational product
- Women of childbearing potential who are sexually active with a non-sterilized male partner must use at least 1 or more effective contraceptive methods from the first dose of the investigational product to 90 days after...
- Must not breastfeed during the study and up to 90 days after the last dose of the investigational product
- Male people who are sexually active with a non-sterilized female partner of childbearing potential must agree to using an effective contraceptive method (spermicide, condom, etc.) from the first dose of the...
What rules you out
- NSCLC with mixed squamous cell histology and tumor with histological transformation (presence of transition from NSCLC to SCLC and epithelial mesenchymal transition)
- For Part A, B, and Cohort 4 of Part C \- people requiring steroid escalation within 28 days before start of the study due to spinal cord compression with uncontrolled symptoms or Central Nervous System (CNS) metastasis...
- For Part Part C: all Cohorts except for Cohort 4 \- people without CNS metastasis
- people who received the following treatments:
- EGFR-TKI treatment within 7 days from the first dose of the investigational product
- Systemic anticancer treatment within 14 days or 5 half-lives (whichever is the shorter period) from the first dose of the investigational product
- Limited field radiation treatment within 7 days or extended field chest radiation treatment within 14 days from the first dose of the investigational product
- Immunotherapy or other antibody therapy within 28 days from the first dose of the investigational product
- people who did not recover from a major surgery or side effects of such treatment, except for vascular access placement, within 28 days from the first dose of the investigational product as determined by the...
- people with the following cardiac dysfunctions or clinically significant cardiac diseases:
- Corrected QT interval using Frederica formula (QTcF) \> 470 ms
- Cardiac arrhythmia that is clinically significant and uncontrolled (e.g. Type II second degree heart block or third degree heart block)
- Any factors increasing the risk of QTc prolongation or arrhythmia occurrence, such as hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death of a family member or direct...
- Uncontrolled (persistent) hypertension: Systolic blood pressure \> 180 mmHg, diastolic blood pressure \> 100 mmHg
- Congestive heart failure defined as New York Heart Association Class III-IV, or hospitalization due to congestive heart failure within 6 months before the first dose of the study intervention
- Medical history of acute myocardial infarction or unstable angina within 6 months before screening
- people with active malignancy other than appropriately treated basal cell cancer or squamous cell skin cancer or carcinoma in situ within 2 years before enrollment. However, those who completed all anticancer treatments...
- people with evidence/past history of interstitial lung disease (ILD) or radiological pneumonia requiring steroid treatment. people with prior ILD related to clinically resolved COVID-19 infection may be enrolled after...
- people who are not able to swallow and keep in the body an orally administered drug and people who have a clinically significant gastrointestinal disorder such as major limitations to the stomach or intestine or...
- people with other uncontrolled active infections, e.g. human immunodeficiency virus (HIV), HBV or HCV, including people with suspected active or latent tuberculosis (confirmed with interferon-gamma emission analysis...
- people with known sensitivity to the study drug or its related substance
- people who have a history of drug abuse or unstable medical, mental or social conditions that may interfere with participation in the study or result interpretation
- people considered not able to follow the protocol as determined by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Goyang-si, Gyeonggi-do, South Korea
- Cheongju-si, North Chungcheong, South Korea
- Seoul, South Korea
- Suwon, South Korea
- Ratchathewi, Bangkok, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Goyang-si, Gyeonggi-do, South Korea; Cheongju-si, North Chungcheong, South Korea; Seoul, South Korea; Suwon, South Korea; Ratchathewi, Bangkok, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.