Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 1 / Phase 2: testing VRN110755 for EGFR-Mutant Non-Small Cell Lung Cancer
This first-in-human, Phase 1/2, multicenter, open-label, non-randomly assigned study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of VRN110755, a highly selective oral epidermal growth factor receptor (EGFR) inhibitor, in patients with EGFR-mutant non-small cell lung cancer (NSCLC). The study includes a Phase 1a dose-escalation portion, a Phase 1b dose-expansion portion, and a Phase 2 evaluation.
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are VRN110755. The registry lists allocation as randomized. This first-in-human, Phase 1/2, multicenter, open-label, non-randomly assigned study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of VRN110755, a highly selective oral epidermal growth factor receptor (EGFR) inhibitor, in patients with EGFR-mutant non-small cell lung cancer (NSCLC).
They plan to enroll about 315 people at 29 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of VRN110755 in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)
Interventions: VRN110755
Primary outcome (registry wording): Estimate of Maximum Tolerated Dose (MTD) of VRN110755
Who it is for (from inclusion criteria)
Ages 18 Years to any
Adults aged 18 years or older (19 years or older in the Republic of Korea)
Histologically or cytologically confirmed advanced, metastatic, or recurrent predominantly nonsquamous non-small cell lung cancer (NSCLC) with a documented epidermal growth factor receptor (EGFR) mutation
At least one measurable extracranial lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Documented EGFR mutation determined by tumor tissue or liquid biopsy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Able to swallow oral capsules and comply with study procedures
No appropriate standard treatment options are available or standard treatment is not considered feasible, in the opinion of the investigator
Who the registry excludes
Received an investigational anticancer therapy within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment
Unresolved side effects from previous anticancer therapy greater than Grade 1 according to the National Cancer Institute Common Terminology Criteria for side effects (CTCAE), except for Grade 2 peripheral neuropathy or alopecia
Pregnant or breastfeeding, or planning to become pregnant during the study
NSCLC with an EGFR or HER2 exon 20 insertion mutation
Another active malignancy within the past 3 years, with the exception of adequately treated cancers considered cured
Inadequate bone marrow, kidney, or liver function based on protocol-defined laboratory criteria
Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of study treatment
Background: The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow patients to under screening and evaluation for participation in NC-SB Protocols.
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate.
The purpose of this research study is to determine the genetic changes and immunologic changes that are involved in the development and progression of bronchogenic lung cancer.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07699328?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07699328?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.