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Phase 1/2 Study of VRN110755 to Assess Safety, Dose and Efficacy in Patients with EGFR‑mutant Non‑Small Cell Lung Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at patients with a specific type of lung cancer called Non-small Cell Lung Cancer that has changes in the EGFR gene. These changes are called mutations and they can make the cancer grow faster. The experimental medicine being tested is a pill named VRN110755. The drug is taken by mouth in capsule form.

The aim of the trial is to find a safe dose and see how well the medicine works in this cancer. Participants will first receive low doses that are gradually increased while doctors watch for side effects and check basic health measures such as blood tests and heart checks. After a safe dose is identified, larger groups will receive that dose to learn whether the tumor shrinks, how long the benefit lasts, and whether the medicine can control disease that has spread to the brain. The study lasts several months, with regular visits for examinations, laboratory tests, and imaging scans to follow the cancer’s response.

The research process

The trial runs in 11 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Screening and Eligibility Confirmation

    You will undergo screening tests to confirm that you have EGFR‑mutant non‑small cell lung cancer (NSCLC) and meet all study requirements.

    Screening includes medical history review, physical examination, laboratory tests, imaging studies, and a blood sample to measure circulating tumor DNA (ctDNA).

  2. Step 2

    Baseline Assessments

    Before receiving any study medication, you will have baseline measurements of vital signs, blood tests, an electrocardiogram (ECG), eye examination, and performance status using the ECOG scale (a measure of daily activity ability).

    Baseline imaging of the chest and any other affected areas will be performed to document the extent of disease.

  3. Step 3

    Start of Study Medication (Phase 1a)

    You will begin taking the investigational drug VRN110755 in capsule form taken by mouth, exactly as instructed by the study team.

    The specific dose amount, frequency, and length of each treatment cycle are defined by the study protocol but are not detailed in the provided information.

  4. Step 4

    Monitoring for Dose‑Limiting Toxicity During Cycle 1

    During the first treatment cycle, you will be closely observed for any side effects that could limit the dose, known as dose‑limiting toxicity (DLT).

    Daily or regular checks will include vital signs, laboratory tests, ECG, eye examination, and assessment of any adverse events (AEs) or serious adverse events (SAEs).

  5. Step 5

    Evaluation of Maximum Tolerated Dose (MTD)

    Based on the safety data collected in Cycle 1, the study team will decide whether the dose you received is safe or if a lower or higher dose should be tested.

    This decision determines the maximum tolerated dose (MTD) for the next part of the study.

  6. Step 6

    Continuation of Phase 1a Treatment

    If the dose is tolerated, you will continue receiving VRN110755 in subsequent cycles, following the same schedule used in Cycle 1.

    Safety monitoring (vital signs, labs, ECG, eye exams, and AE/SAE reporting) will be repeated at the start of each new cycle.

  7. Step 7

    Phase 1b – Treatment at Selected Dose Levels

    In Phase 1b, you will receive VRN110755 at one of two dose levels that were selected from Phase 1a results.

    The medication is still taken orally as a capsule, and you will be assigned to one of four groups defined by biomarkers and previous treatment history.

    Each treatment cycle will include the same safety checks as before, plus additional blood draws to measure changes in ctDNA at the start of every cycle.

  8. Step 8

    Determination of Recommended Phase 2 Dose (RP2D)

    After reviewing safety and early efficacy data from Phase 1b, the study team will identify the dose that provides the best balance of benefit and tolerability, called the recommended Phase 2 dose (RP2D).

    This dose will be used for all participants entering Phase 2.

  9. Step 9

    Phase 2 – Efficacy Evaluation

    You will continue taking VRN110755 at the RP2D in regular treatment cycles.

    The primary goal in this phase is to assess how well the drug works, using measures such as objective response rate (tumor shrinkage), duration of response, disease control rate, progression‑free survival, and overall survival.

    Imaging studies will be performed at scheduled intervals to evaluate tumor size, and blood samples will be taken to monitor ctDNA at screening, Cycle 2 Day 1 (C2D1), Cycle 3 Day 1 (C3D1), and at the end of treatment (EOT).

  10. Step 10

    End of Treatment and Final Assessments

    When the predetermined treatment period ends or if the study drug must be stopped because of safety or disease progression, you will discontinue VRN110755 and undergo final safety assessments.

    These assessments include vital signs, laboratory tests, ECG, eye examination, performance status, and a final imaging scan.

  11. Step 11

    Post‑Treatment Follow‑Up

    After stopping the study medication, you will be monitored for additional safety information for a period defined by the study protocol.

    Follow‑up visits will include basic health checks and may include additional imaging or laboratory tests to track any late‑appearing side effects.

Who can join the trial?

14 criteria

  • Be at least 18 years old (in Korea you must be 19 or older).
  • Be able to understand the study information, sign an informed consent form, and follow the study rules.
  • Have at least one tumor spot outside the brain that can be measured on a scan, as defined by the RECIST 1.1 criteria (a standard way doctors measure tumor size).
  • Have a confirmed diagnosis of advanced, metastatic, or recurrent non‑small cell lung cancer (NSCLC) that carries an EGFR mutation and has not changed into small‑cell lung cancer or another neuroendocrine tumor.
  • Have the EGFR mutation identified by a blood test called a liquid biopsy or by testing a tissue sample from the tumor.
  • Have an ECOG performance status of 0 or 1, meaning you are fully active (0) or able to carry out light work (1).
  • Be able to swallow oral medication and follow the study visits and procedures.
  • Agree to use contraception as required by the study (if applicable).
  • Have no suitable standard treatment options available, as decided by your doctor.
  • Phase 1a specific: Have any activating EGFR mutation (examples: Del19, L858R, C797S, or other uncommon/complex mutations) and have disease progression shown on imaging after at least two cycles of standard EGFR‑TKI therapy, or have stopped standard therapy because of side effects and have no benefit from other treatments.
  • Phase 1b Cohort A: Have an EGFR Del19 or L858R mutation together with a C797X mutation and have progressed after using a third‑generation EGFR‑TKI (such as osimertinib, lazertinib, or aumolertinib) as first‑line treatment.
  • Phase 1b Cohort B: Have a common EGFR mutation and have never received any cancer treatment for this disease (treatment‑naïve).
  • Phase 1b Cohort C: Have an atypical or uncommon EGFR mutation (examples: G719X, L861Q, S768I, E709X, R776H, L747S, or a combination) and have received at least one prior systemic therapy, including an EGFR‑TKI, stopped that therapy because of side effects, and have no benefit from other standard treatments.
  • Phase 1b Cohort D: Have an atypical EGFR mutation and have never received any cancer treatment for this disease (treatment‑naïve).

Who cannot join the trial?

38 criteria

  • Have taken any experimental cancer drug within 14 days (or five half‑lives, the time it takes for half the drug to leave the body) before the first study dose.
  • Have a known history of, or currently have, human immunodeficiency virus (HIV) infection.
  • Have received a live vaccine (a vaccine containing a weakened form of the germ) within 4 weeks before the first study dose.
  • Have taken strong or moderate medicines that block or increase the activity of the liver enzyme CYP3A, or have used herbal supplements that affect this enzyme, within 2 weeks before the first study dose.
  • Have had major surgery (a large operation) within 4 weeks before the first study dose.
  • Have received certain cancer treatments before the first study dose:
    • Any chemotherapy or systemic therapy within 14 days (or five half‑lives) before the dose.
    • Any antibody therapy or immunotherapy within 28 days before the dose.
    • Any radiation therapy to a large area or to a vital organ within 14 days (or 7 days if the organ was not included).
    • Have cancer that has spread to the brain or spinal cord (CNS metastases) or have spinal cord compression that is causing worsening nerve symptoms or needs increasing steroid medication (prednisone more than 10 mg per day).
    • Need daily steroid medication (like prednisone) at a dose higher than 10 mg per day for any reason.
    • Have certain heart problems, such as:
      • A QTc interval (a measurement on an ECG) longer than 470 milliseconds.
      • Irregular heart rhythms that need treatment, uncontrolled atrial fibrillation, or persistent ventricular fibrillation.
      • History of heart failure, low potassium (hypokalemia), a dangerous rhythm called Torsade de Pointes, or a congenital long QT syndrome.
      • Past heart procedures (bypass surgery, stents), heart attack, unstable chest pain, moderate or severe congestive heart failure, high blood pressure (systolic >160 mmHg or diastolic >100 mmHg), or a left‑ventricular ejection fraction below 50% within the last 6 months.
      • Use of medicines that are known to lengthen the QT interval within 2 weeks before the first dose.
      • Have a past or current non‑infectious lung inflammation (pneumonitis) or interstitial lung disease that required steroids or is still present.
      • Are unable to swallow capsules, or have severe nausea, vomiting, or gastrointestinal problems that would prevent the drug from being absorbed.
      • Still have side effects from previous chemotherapy that have not improved to a mild level (CTCAE grade ≤ 1), except mild nerve problems or hair loss.
      • Are allergic to the active ingredient of the study drug or think they might be allergic.
      • Are considered unsuitable for the study by the doctor in charge.
      • Have a history of alcohol or drug abuse within the past 2 years, or have a current psychological or social condition that could affect participation, as judged by the doctor.
      • Have used acid‑reducing medicines (such as proton‑pump inhibitors, PPIs, or H2‑blockers) or antacids within 7 days before the first dose.
      • For the later parts of the study (cohorts A‑D), have other known cancer‑driving genetic changes that already have approved treatments, such as:
        • Increased copies of c‑MET or HER2,
        • Gene fusions involving ALK, ROS1, NTRK, or RET,
        • Mutations in BRAF (V600E) or KRAS (G12X).
        • Are pregnant, are breastfeeding, or could become pregnant and do not agree to use effective birth control.
        • Have a type of EGFR or HER2 mutation called an Exon20 insertion, which is not allowed in this study.
        • Have had another active cancer within the past 3 years.
        • Have certain blood test results at screening, such as:
          • Low white blood cell count (<2.5 × 10⁹/L),
          • Low neutrophil count (<1500/µL),
          • Low platelet count (<100 000/µL),
          • Low hemoglobin (<9.0 g/dL),
          • Kidney function (creatinine clearance) below 60 mL/min,
          • High bilirubin (>1.5 times the upper normal limit),
          • High liver enzymes (AST or ALT) more than 2.5 times the upper limit (or >5 times if liver metastases are present).
          • Have an active infection (including tuberculosis) that needs systemic antibiotic, antifungal, or antiviral treatment within 14 days before the first dose.
          • Have chronic hepatitis B infection at screening.
          • Have chronic hepatitis C infection at screening.
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Investigated drugs

VRN110755 is an experimental oral capsule being tested as a new treatment for patients with non‑small cell lung cancer that has a specific EGFR mutation. In this early‑stage study, researchers are giving the capsule to participants to see if it is safe to use, how well the body processes it, and whether it can help control the cancer. The drug is taken by mouth, and the trial will look at different dose levels to find the amount that works best with acceptable side effects.

What is already known about the treatment

VRN110755 - VRN110755 is taken by mouth as a capsule. It is an experimental drug currently being studied in early‑phase clinical trials and is not yet approved for general medical use. The drug is designed to treat non‑small cell lung cancer that carries mutations in the EGFR gene. It works by blocking the activity of the EGFR protein, which stops the signal that makes cancer cells grow, and it belongs to the class of targeted oral tyrosine‑kinase inhibitors.

Investigated diseases

EGFR‑mutant non‑small cell lung cancer - It is a type of lung cancer that starts in the cells lining the airways. Some tumors have changes in the EGFR gene that make them grow faster. The disease often begins as a small tumor in the lung and can spread to nearby lymph nodes and other organs. It may cause coughing, shortness of breath, or chest pain as it grows. Over time, the cancer can become more widespread, affecting other parts of the body such as the brain or bones. The progression varies from person to person.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2025-523122-40-00Protocol codeVRN110755_01Estimated enrolment360 patients

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