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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
Patients with non-small cell lung cancer (NSCLC) harboring a mutation that is sensitive to osimertinib must have received osimertinib prior to enrollment
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have NSCLC with a mutation treatable by osimertinib and have received it.
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I can perform daily activities with minimal assistance.
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I am 18 years old or older.
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My cancer has an EGFR mutation and has worsened despite standard treatments.
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My lung cancer has a specific EGFR mutation and affects my brain or spinal cord.
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I agree to use highly effective birth control during and for 3 months after treatment.
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My NSCLC has rare EGFR mutations not commonly targeted by current therapies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4.5 years for reporting.

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 more
Secondary 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 more

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.

Find a Location

Who is running the clinical trial?

Nalo Therapeutics Inc.Lead Sponsor

Media Library

NX-019 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05514496 — Phase 1
Tumors Research Study Groups: Part 1: NX-019 Dose Escalation, Part 2: NX-019 Dose Expansion
Tumors Clinical Trial 2023: NX-019 Highlights & Side Effects. Trial Name: NCT05514496 — Phase 1
NX-019 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05514496 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the Part 2: NX-019 Dose Expansion protocol endorsed by FDA regulators?

"Due to the limited evidence backing its efficacy and safety, Part 2: NX-019 Dose Expansion was assigned a score of 1 on our team's scale from 1 to 3."

Answered by AI

Is it currently possible to join the research program?

"Affirmative. Clinicaltrials.gov displays that this clinical trial is still collecting patients, with the initial post dating back to October 5th 2022 and a last edit on November 17th 2022. A total of 178 participants are anticipated from two different sites."

Answered by AI

What is the population size of participants involved in this clinical experiment?

"Affirmative. Clinicaltrials.gov reveals that this clinical research, which was first published on October 5th 2022, is actively recruiting for 178 volunteers at 2 distinct centres."

Answered by AI
~169 spots leftby Feb 2027