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EGFR-TKI agent
JIN-A02 for Non-Small Cell Lung Cancer
Phase 1 & 2
Recruiting
Research Sponsored by J Ints Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with pathologically confirmed and finally diagnosed advanced and/or metastatic NSCLC with active EGFR mutant
Male subjects who are sexually active with a non-sterilized female partner of childbearing potential must agree to using an effective contraceptive method and not donating their sperms
Must not have
Subjects without CNS metastasis for specific cohorts
Subjects who are not able to swallow and keep in the body an orally administered drug and subjects who have a clinically significant gastrointestinal disorder such as major limitations to the stomach or intestine or malabsorption syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group
Summary
This trialwill evaluate the safety and effectiveness of a 4th gen EGFR-TKI agent for advanced NSCLC with EGFR mutations. Subjects will be tested for EGFR mutants and receive doses based on safety & anti-tumor activity.
Who is the study for?
Adults with advanced non-small cell lung cancer (NSCLC) that has specific EGFR mutations and worsened after standard treatments, including certain drugs or chemotherapy. They must be generally healthy, able to take oral medication, and have at least one measurable tumor lesion. Women of childbearing age and sexually active men must use effective contraception.
What is being tested?
The trial is testing JIN-A02, a new oral drug for NSCLC patients with certain EGFR mutations who've seen their cancer progress post-treatment. It's in three parts: dose escalation to find the maximum tolerated dose, dose exploration for safety and optimal dosing levels, then expanding doses across different patient groups based on mutation type.
What are the potential side effects?
While not explicitly listed in the provided information, side effects may include typical reactions to cancer medications such as nausea, fatigue, skin rash or diarrhea due to its nature as an EGFR-TKI agent. Organ-specific inflammation or allergic reactions could also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced lung cancer has an active EGFR mutation.
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I am a man who will use birth control and not donate sperm.
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I am at least 18 years old (19 if I'm in South Korea).
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has not spread to my brain.
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I cannot take pills by mouth or have serious stomach/intestine problems.
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I have no active cancer except for certain skin cancers or localized cancers that haven't spread.
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I have a heart condition that affects how my heart works.
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My lung cancer has changed from non-small cell to small cell type.
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I have had lung diseases or pneumonia that needed steroids.
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I do not have any uncontrolled infections like HIV, hepatitis B or C, or tuberculosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events (AE) rate
Dose Limiting Toxicity (DLT)
Maximum Tolerable Dose (MTD)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Phase 1 dose-escalation, Phase 1 dose-exploratory, Phase 2 dose-expansionExperimental Treatment1 Intervention
Single arm
Find a Location
Who is running the clinical trial?
J Ints BioLead Sponsor
2 Previous Clinical Trials
Ethan SeahStudy DirectorJ Ints Bio
2 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you had side effects from a previous treatment, they should have either gone back to how they were before or be very mild, unless the side effect doesn't pose a safety risk. If you have a long-term condition from the previous treatment that is not expected to get much better, you can still join the trial.My advanced lung cancer has an active EGFR mutation.I am a man who will use birth control and not donate sperm.My blood tests for liver, kidney, and bone marrow function are within normal ranges.My cancer has a confirmed EGFR mutation from a test on tumor tissue or blood.My cancer has not spread to my brain.I need more steroids for my spinal or brain condition before joining the study.My cancer has worsened after standard treatment, including an EGFR-TKI drug.I am at least 18 years old (19 if I'm in South Korea).I cannot take pills by mouth or have serious stomach/intestine problems.I have a tumor that can be measured and hasn't been treated with radiation.I am fully active or can carry out light work.My advanced NSCLC has specific EGFR mutations.I have no active cancer except for certain skin cancers or localized cancers that haven't spread.I have a heart condition that affects how my heart works.My lung cancer has changed from non-small cell to small cell type.I have had lung diseases or pneumonia that needed steroids.People with specific mutations in their EGFR genes and advanced lung cancer can participate in the study.I do not have any uncontrolled infections like HIV, hepatitis B or C, or tuberculosis.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 dose-escalation, Phase 1 dose-exploratory, Phase 2 dose-expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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