What side effects are associated with this type of intervention?

Common treatments for tumors, particularly those involving EGFR inhibitors like gefitinib, often result in side effects such as diarrhea, skin toxicity (including rash and dry skin), and ocular issues like trichomegaly and keratitis. When combined with other agents like docetaxel and estramustine, additional side effects can include fatigue, nausea, and peripheral edema. These side effects are generally consistent with the known profiles of these medications.

What prior FDA approvals exist?

Several EGFR inhibitors have received FDA approval for the treatment of tumors, particularly non-small cell lung cancer (NSCLC) with EGFR mutations. Notable examples include erlotinib (Tarceva), gefitinib (Iressa), and osimertinib (Tagrisso). These drugs target the epidermal growth factor receptor (EGFR) pathway, which is often mutated in various cancers, leading to uncontrolled cell growth. These inhibitors have shown efficacy in improving progression-free survival and overall response rates in patients with EGFR-mutant NSCLC.

What other types of research exist?

Promising alternatives to NX-019 for EGFR-mutant tumors include nogalamycin N-oxide (NSC116555), which has demonstrated potent cytotoxic effects against non-small-cell lung cancer cells. Additionally, combinations such as neratinib with trastuzumab or temsirolimus have shown enhanced therapeutic benefits in HER2 mutant non-small cell lung cancer. These alternatives could be considered for treatment in 2024.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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.

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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.