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Protocol NumberVRN110755_01
Active

2024-04-30 - 2027-04-30

Phase I

Recruiting5

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Phase 1 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)

  • Sponsor

    Voronoi, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-small Cell Lung Cancer (NSCLC)

Objectives

Primary: • to evaluate the safety and tolerability of VRN110755 in patients with EGFR mutant NSCLC

Test Drug

tablet

Active Ingredient

VRN110755

Dosage Form

110

Dosage

10 mg, 30 mg and 120 mg

Endpoints

• incidence of DLTs (Phase 1a Cycle 1
only)
• incidence of adverse events
(AEs)/serious AEs (SAEs)
• vital signs
• laboratory tests
• physical/ophthalmic examinations
• electrocardiogram
• ECOG performance status

Inclution Criteria

1. ≥18 years of age (≥19 years of age for Korean).
2. Able to comprehend and willing to sign an informed consent form and to abide by the
study restrictions.
3. Have at least 1 evaluable lesion (measurable or non-measurable) based on RECIST
Version 1.1.
4. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic
NSCLC without SCLC transformation.
5. EGFR mutation profile determined by liquid biopsy or pre-existing tumor biopsy
result.
6. Eastern Cooperative Oncology Group performance status 0 to 1.
7. Agree to abide by contraception guidance (Appendix 4).
• Women of childbearing potential who are not currently pregnant or breast-feeding
and agree to maintain effective contraceptive method during the study and for up to
6 months after the last follow-up visit.
• Men who agree to maintain effective contraceptive method during the study and
for up to 6 months after the follow-up visit.
8. Phase 1a:
• NSCLC with any EGFR activating mutations including Del19, L858R, C797S,
and uncommon or complex mutations.
• Patients with PD confirmed by radiological evaluation even with standard of care
including EGFR TKI treatment for at least 2 cycles; treatment discontinued due to
toxicity; and medically confirmed to derive no clinical benefit from other standard
therapies.
• Patients with no appropriate standard treatment options approved in participating
countries by investigator’s determination.
9. Phase 1b:
• NSCLC with an EGFR dual mutation of C797S and Del19 or L858R.
• Patients confirmed to harbor C797S resistance mutation among patients whose PD
was confirmed by radiological evaluation even with third-generation EGFR TKI
treatment, including osimertinib and lazertinib as first-line treatment for at least 2
cycles, or whose treatment was discontinued due to toxicity, or who are
determined to derive no clinical benefit from other standard therapies.

Exclusion Criteria

1. Currently receiving other investigational medicinal product (IMP)or have received
other IMP within 4 weeks of the first dose of this IMP.
2. Adverse events from previous chemotherapy that have not recovered to Common
Terminology Criteria for Adverse Events Grade ≤ 1 level (≤Grade 2 peripheral
neuropathy or hair loss is acceptable).
3. Pregnant women, breast-feeding women, or women of childbearing potential who
plan to get pregnant.
4. Tumor that harbors EGFR Exon20 Insertion mutation.
5. History of other active malignancy within 3 years prior to screening.
6. Patients with following test findings during the screening test:
• Hematology (transfusion or hematopoietic growth factor administration within
14 days prior to test is not allowed)
White blood cell (WBC) count < 2.5 × 109/L
Absolute neutrophil count (ANC) < 1500/µL
Platelets < 100 000/µL
Hemoglobin < 9.0 g/dL
• Blood chemistry
Creatinine clearance < 60 mL/min according to the Cockroft-Gault equation
Total bilirubin > 1.5 × ULN
Aspartate aminotransferase/transaminase; AST (SGOT) > 2.5 × ULN (>5 × ULN
with liver metastases)
Alanine aminotransferase/transaminase; ALT (SGPT) > 2.5 × ULN (>5 × ULN
with liver metastases)
Note: Patients who have previously received chemotherapy and have a creatinine
clearance between 50 and 60 mL/min, which is considered suboptimal for renal
function, may be eligible for enrollment.
7. Active infections (including tuberculosis infection, etc.) requiring systemic
antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose of the
IMP.
8. Patient has active or chronic hepatitis B at screening.
Note: Patients with HBsAg positive can be enrolled if viral load (HBV DNA) is
undetectable. Patients receiving antivirals at screening should have been treated for
>2 weeks before first dose of the IMP.
9. Patient has active or chronic hepatitis C.

The Estimated Number of Participants

  • Taiwan

    17 participants

  • Global

    50 participants

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