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VIC-1911 Combined With Osimertinib for EGFR -Mutant Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE1

VIC-1911 Combined With Osimertinib for EGFR -Mutant Non-small Cell Lung Cancer

Phase I Clinical Study of VIC-1911 Combined With Osimertinib in the Treatment of Advanced Non-small Cell Lung Cancer With EGRF- Mutation

NCT05489731•Jiesi Yingda Pharmaceutical Technology (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a nonrandomized, open phase I dose escalation and extension clinical study designed to evaluate Aurora A inhibitor VIC-1911 tablets in combination with oxitinib in Chinese patients with advanced non-small cell lung cancer The safety, tolerability, pharmacokinetic characteristics and preliminary antitumor efficacy were analyzed. The entire study included the screening period (28 days prior to initialadministration of the investigational drug) and the treatment period (Cycle) EoT is defined as disease progression or intolerable toxicity or premature withdrawal Out\]) and the safety follow-up period (28 days after EoT). During dose increments and expansions, subjects followed Safety assessment, PK blood collection, imaging examination and efficacy assessment were performed during the visit plan. Observation subject The safety, tolerability, and occurrence of DLT until disease progression, occurrence of intolerable toxicity, Death, withdrawal of informed consent, loss of follow-up or termination of the study by the sponsor shall prevail.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily participate in clinical research, sign written informed consent, and be able to abide by clinical visits and research Relevant procedures;
•2. Male or female patients aged 18-75 (including boundary value) when signing the informed consent form;
•3. NSCLC with advanced EGFR mutation positive \[exon 19 deletion (19del) and exon 21 L858R (21l858r) point mutation\] confirmed by cytology or histology A. only applicable to the dose increasing stage: after receiving the first / second generation EGFR-TKI treatment failure T790M mutation negative or third-generation EGFR-TKI treatment failed, and then received platinum containing dual drug chemotherapy Terminal NSCLC patients after failure; B. only applicable to the expansion phase: (1) queue 1: after the treatment failure of the first / second generation EGFR-TKI NSCLC patients with T790M mutation positive; (2) Cohort 2: NSCLC patients who failed to receive three generations of EGFR-tki treatment;
•4. According to RECIST 1.1 standard, patients must have a passing shadow Measurable lesions assessed by imaging examination;
•5. The EC0G score is 0 or 1;
•6. Estimated survival time ≥ 3 months;
•7. Bone marrow reserve and organ function level within 7 days before administration must meet the following requirements:
•1. Bone marrow reserve: hemoglobin (HB) ≥ 9.0 g/dl, absolute neutrophil count （ANC）≥ 1.5 × 109/l, platelet (PLT) ≥ 100 × 109/l, opened during the study treatment period Blood transfusion (whole blood, platelets or red blood cells) is prohibited 1 month before the start;
•2. Coagulation function: international normalized ratio (INR) ≤ 1.5 × Upper normal value (ULN), active Partial prothrombin time (APTT) ≤ 1.5 × ULN；
•3. Liver function: aspartate aminotransferase (AST) and alanine in the absence of liver metastasis Transaminase (ALT) ≤ 2.5 × ULN； In case of liver metastasis, AST and alt ≤ 5.0 × ULN；Total bilirubin in serum (TBIL) ≤ 1.5 × ULN (patients known to have Gilbert syndrome Only when total bilirubin ≤ 3 × ULN, direct bilirubin ≤ 1.5 × In the case of ULN, it will be Consider);
+3 more criteria

Exclusion Criteria

•1. Known allergy to, or hypersensitivity to, VIC-1911, osimertinib, or any of the excipient ingredients
•2. Subject has previously discontinued osimertinib due to toxicity or other safety events Interstitial lung disease/non-infectious pneumonia; Symptoms or signs of severe arrhythmia with prolonged QTc interval; Symptomatic congestive heart failure
•3. Other side effects caused by previous treatment did not alleviate to CTCAE≤ grade 1, alopecia or otherwise
•4. A history of ocular disease was present, and the patient had occlusion of central or branch retinal arteries or veins with visual acuity Significant decline, or a history of visual impairment due to other retinal diseases as determined by an ophthalmologist or Performance
•5. The following infectious diseases are known to be active, such as:
•Human immunodeficiency virus antibody (HIV-AB) positive; Hepatitis B surface antigen (HBsAg) positive and HBV-DNA exceeding the upper limit of normal value; Hepatitis C virus antibody (HCV-AB) positive and HCV RNA positive
•6. Other active infections requiring intravenous antibiotics within 7 days before administration;
•7. Use of potent CYP inducer 28 days before administration or within 5 half-lives of the drug, whichever is longer A guide or inhibitor;
•8. Had undergone a major surgical procedure within 28 days prior to drug administration or was expected to require a major procedure during the trial Surgery;
•9. Received the latest antitumor therapy (chemotherapy, targeted therapy, radiotherapy, immunotherapy, biological therapy) Therapy or endocrine therapy), less than 5 half-lives after or after the first administration of the drug Less than 28 days (whichever is longer). Had received the drug within 14 days before the first dose with definite resistance The effect of traditional Chinese medicine on tumor;
+12 more criteria

Locations (1)

Zhangli

Guangdong, China

Key Dates

Start Date

September 21, 2022

Primary Completion Date

February 24, 2024

Completion Date

April 24, 2024

Last Updated

June 15, 2023

Enrollment

ESTIMATED participants

Conditions

Advanced Non-small Cell Lung Cancer

Interventions

VIC-1911

DRUG

Osimertinib Mesylate Tablets

DRUG

Contacts

li zhang, professor

CONTACT

13902282893 zhangli6@mail.sysu.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

VIC-1911 Combined With Osimertinib for EGFR -Mutant Non-small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

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