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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 years
Awards & highlights
Study Summary
This trial tests a new drug to see if it's safe & effective for advanced EGFR-mutant cancer patients.
Who is the study for?
Adults with advanced EGFR-mutant cancer, specifically non-small cell lung cancer (NSCLC), who have progressed after standard therapy or are intolerant to it. Participants must have measurable disease, a life expectancy of at least 3 months, and adequate organ function. They should not be pregnant or breastfeeding and must agree to effective birth control during the study.Check my eligibility
What is being tested?
The trial is testing NX-019's safety, tolerability, and preliminary effectiveness in patients with advanced cancers that have a mutation in the epidermal growth factor receptor (EGFR). It's an open-label study where all participants receive NX-019.See study design
What are the potential side effects?
While specific side effects for NX-019 aren't listed here, common side effects for drugs targeting EGFR mutations may include diarrhea, skin rash or acneiform eruptions, dry skin, nail changes, mouth sores and potential liver enzyme elevations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 and Part 2: Incidence of Adverse Events of Special Interest (AESIs)
Part 1 and Part 2: Incidence of Serious Adverse Events (SAEs)
Part 1 and Part 2: Incidence of Treatment-emergent Adverse Events (TEAEs)
+1 moreSecondary outcome measures
Part 1 and Part 2: AUC from Time 0 to Infinity (AUC0-inf) of NX-019
Part 1 and Part 2: AUC from Time 0 to the Time of Last Quantifiable Plasma Concentration (AUC0-t) of NX-019
Part 1 and Part 2: Accumulation Index Using Cmax (AICmax) and Accumulation Index Using AUC (AIAUC0-inf) of NX-019
+18 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part 2: NX-019 Dose ExpansionExperimental Treatment1 Intervention
Patients will be treated with the REDs of NX-019 as determined in Part 1.
Group II: Part 1: NX-019 Dose EscalationExperimental Treatment1 Intervention
Patients will be treated with NX-019 in multiple ascending cohorts.
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Who is running the clinical trial?
Nalo Therapeutics Inc.Lead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My NSCLC has an EGFR mutation and doesn't fit other specific group criteria.I have not had radiation therapy in the last 4 weeks.My organs and bone marrow are working well.I am currently taking medication that strongly affects liver enzyme activity.I can perform daily activities with minimal assistance.My cancer has a specific EGFR mutation or another known driver.I have or had another type of cancer.I have had a serious lung condition that needed steroids.I have a digestive condition that could affect how my body absorbs medication.My lung cancer has a specific mutation and has spread to my brain or spinal cord.I have not had major surgery in the last 3 weeks.I haven't had serious heart problems in the last 6 months.My cancer has an EGFR mutation and has worsened despite standard treatments.I agree to use highly effective birth control during and for 3 months after treatment.I haven't had cancer treatment or experimental drugs in the last 2 weeks or 5 half-lives.My NSCLC has rare EGFR mutations not commonly targeted by current therapies.I am currently on medication for an infection.My NSCLC has EGFR ex20ins mutations and I haven't had targeted therapy for it.I have tested positive for HIV, HBV, or HCV.I have NSCLC with a mutation treatable by osimertinib and have received it.I am 18 years old or older.I do not have severe health issues like uncontrolled diabetes or mental health problems.My side effects from previous cancer treatments are mild or gone, except for hair loss or some nerve pain.My lung cancer has a specific EGFR mutation and affects my brain or spinal cord.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: NX-019 Dose Escalation
- Group 2: Part 2: NX-019 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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