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NX-019 for EGFR-Mutant Cancer
Phase 1
Recruiting
Research Sponsored by Nalo Therapeutics Inc.
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 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing NX-019, a new drug, in patients with advanced or metastatic EGFR-mutant cancer. The drug aims to block a protein that helps cancer cells grow, potentially slowing down or stopping the cancer. NRC-AN-019 has shown better antitumor activity than Lapatinib in pre-clinical breast cancer models.
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.
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.
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 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for tumors, especially those with specific genetic mutations like EGFR, include targeted therapies such as EGFR inhibitors. These inhibitors, like NX-019, work by blocking the epidermal growth factor receptor (EGFR) pathway, which is often overactive in certain cancers, leading to uncontrolled cell growth and proliferation.
By inhibiting this pathway, these drugs can effectively slow down or stop the growth of cancer cells. This is crucial for patients because it offers a more personalized treatment approach, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.
Find a Location
Who is running the clinical trial?
Nalo Therapeutics Inc.Lead Sponsor
Media Library
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.