VRN110755 for Lung Cancer
(REACH-EGFR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new pill, VRN110755, for individuals with non-small cell lung cancer (NSCLC) that involves specific genetic changes in the EGFR gene. The study aims to determine the safest dose and evaluate its effectiveness against tumors. It targets those who have not responded to other treatments or have uncommon EGFR mutations. Ideal participants have EGFR-mutant NSCLC and have either undergone previous treatments or are newly diagnosed with no other options. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group.
Is there any evidence suggesting that VRN110755 is likely to be safe for humans?
Research has shown that treatments targeting the EGFR (epidermal growth factor receptor) for non-small cell lung cancer often cause side effects, but these are usually manageable. Studies indicate that severe side effects occur in a small number of patients, ranging from 8% to 38%, depending on the treatment.
Common side effects include stomach and intestinal issues. However, many patients tolerate these treatments well, especially when doctors adjust the dosage. This suggests that VRN110755, which specifically targets EGFR, might have similar safety characteristics.
VRN110755 remains in early testing, so researchers are still collecting safety information. During these early phases, they gather detailed data to ensure safety and determine the best dosage. This process helps reduce severe side effects and improve the overall experience for patients.12345Why do researchers think this study treatment might be promising for lung cancer?
Researchers are excited about VRN110755 for treating EGFR-mutant non-small cell lung cancer (NSCLC) because it targets specific EGFR mutations that current therapies like osimertinib, lazertinib, and aumolertinib might not fully address. Unlike these standard treatments, VRN110755 is designed to tackle a wider range of resistance mutations, such as C797X, and uncommon mutations, offering a broader scope of action. This could lead to better outcomes for patients who have progressed on existing therapies and those with rare, hard-to-treat mutations.
What evidence suggests that VRN110755 might be an effective treatment for lung cancer?
Research has shown that VRN110755 could be a promising treatment for EGFR-mutant non-small cell lung cancer (NSCLC). This trial will evaluate VRN110755 across various treatment arms, each focusing on different patient groups with specific EGFR mutations. The new medicine targets specific changes in cancer cells, helping to stop their growth. Studies have found that similar treatments can reduce tumor size noticeably in about 37.5% of patients. Additionally, patients using these treatments experienced an average period of about 10.2 months during which their cancer did not worsen. These findings suggest that VRN110755 might effectively treat patients with NSCLC who have certain EGFR mutations.678910
Who Is on the Research Team?
Hongryul Jung, PhD
Principal Investigator
Voronoi, Inc
Are You a Good Fit for This Trial?
This trial is for people with non-small cell lung cancer that has a mutation in the EGFR gene. It includes those whose cancer has stopped responding to previous EGFR-targeted treatments. Participants must be adults and generally healthy enough for study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1a Dose Escalation
Participants receive escalating dose levels of VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity and to determine the maximum tolerated dose (MTD).
Phase 1b Dose Expansion
Participants receive VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity across molecularly defined EGFR-mutant NSCLC cohorts and determine the recommended Phase 2 dose (RP2D).
Phase 2 Evaluation
Selected expansion cohorts continue to further evaluate the efficacy, safety, tolerability, and pharmacokinetics of VRN110755.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VRN110755
Trial Overview
The study is testing VRN110755, a new oral drug designed to target EGFR mutations in lung cancer. The trial will find the safest dose and see how well it works against tumors, starting with small groups at different doses before expanding to more patients.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Treatment-naïve participants with NSCLC harboring atypical EGFR mutations. Participants receive VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity in patients who have not previously received systemic treatment for EGFR-mutant NSCLC.
Participants with NSCLC harboring atypical or uncommon EGFR mutations, including G719X, L861Q, S768I, E709X, R776H, L747S, or combinations thereof, who have previously received at least one prior systemic therapy, including an EGFR TKI, and have no remaining standard treatment options expected to provide clinical benefit. Participants receive VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity.
Treatment-naïve participants with NSCLC harboring common EGFR mutations. Participants receive VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity in patients who have not previously received systemic treatment for EGFR-mutant NSCLC.
Participants with EGFR-mutant NSCLC harboring exon 19 deletion or exon 21 L858R mutations and a C797X resistance mutation following progression on first-line third-generation EGFR TKI therapy, including osimertinib, lazertinib, or aumolertinib. Participants receive VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity and to support selection of the recommended Phase 2 dose.
Participants with advanced, metastatic, or recurrent EGFR-mutant non-small cell lung cancer (NSCLC) who have experienced disease progression following prior EGFR tyrosine kinase inhibitor (TKI) therapy and harbor activating, resistant, uncommon, or complex EGFR mutations. Participants receive escalating dose levels of VRN110755 to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity and to determine the maximum tolerated dose (MTD).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Voronoi, Inc
Lead Sponsor
Citations
Clinical outcome of treatment of metastatic non-small cell lung ...
The objective response rate was 37.5% in the EGFR-TKI group. Median progression-free survival (PFS) in the EGFR-TKI group was 10.2 months. Median PFS among the ...
2.
cancernetwork.com
cancernetwork.com/view/interpreting-overall-survival-and-cns-outcomes-in-egfr-mutated-metastatic-non-small-cell-lung-cancerInterpreting Overall Survival and CNS Outcomes in EGFR ...
In this segment, Dr. Singhi discusses how overall survival data from recent phase 3 trials in EGFR mutated metastatic non-small cell lung ...
Real-World Treatment Patterns, Epidermal Growth Factor ...
Among 61 patients progressing on and discontinuing a first 1G/2G EGFR-TKI, 45 (73.8%) received subsequent systemic treatment while 16 (26.2%) ...
4.
memoinoncology.com
memoinoncology.com/egfr-mutant-lung-cancer-whats-new-with-respect-to-activity-and-resistance/EGFR-mutant lung cancer: what's new with respect to ...
ORR constituted the primary endpoint. Neoadjuvant erlotinib indeed increased ORR, although not to a significant degree (54.1 % vs. 34.3 %; p = 0.092). The ...
Are They Different from Those with Common EGFR ...
The median progression-free survivals (PFSs) were 8.6 months (95% CI: 3.8-13.5), 11.7 months (95% CI: 6.6-16.7), 7.7 months (95% CI: 4.9-17.4), ...
EGFR Oncogenic Mutations in Non-Small Cell Lung Cancer
FDA-approved for the treatment of patients with EGFR-mutated non-small cell lung cancer
Efficacy and safety of EGFR-TKI for EGFR-mutated NSCLC
safety has the highest objective remission rate, it also increases the possibility of grade ≥3 AEs.
Efficacy and safety of therapies for EGFR-mutant non-small ...
Severe adverse events (toxicity grade≥ 3) were found in 7 (8%) and 28 (38%) patients. The most common adverse events were gastrointestinal ...
Non-Small Cell Lung Cancer
VRN110755 Non-Small Cell Lung Cancer (NSCLC) Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of VRN110755 in Patients with ...
10.
mdedge.com
mdedge.com/fedprac/avaho/article/257039/lung-cancer/safety-profile-mutant-egfr-tk-inhibitors-advanced-non-smallSafety Profile of Mutant EGFR-TK Inhibitors in Advanced ...
Adverse effects caused by mutant EGFR-TK inhibitors are significant but are usually tolerable and can be avoided by reducing the dosage of it ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.