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Advanced Non-small Cell Lung CancerPhase 1VIC-1911NCT05489731

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

A Phase 1 study testing VIC-1911 and Osimertinib Mesylate Tablets in people with Advanced Non-small Cell Lung Cancer, run by Jiesi Yingda Pharmaceutical Technology (Suzhou) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Non-small Cell Lung Cancer
What is being tested?
VIC-1911 and Osimertinib Mesylate Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
21 Sep 2022to 24 Apr 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in clinical research, sign written informed consent, and be able to abide by clinical visits and research Relevant procedures;
  • Male or female patients aged 18-75 (including boundary value) when signing the informed consent form;
  • 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;
  • According to RECIST 1.1 standard, patients must have a passing shadow Measurable lesions assessed by imaging examination;
  • The EC0G score is 0 or 1;
  • Estimated survival time ≥ 3 months;
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  • Bone marrow reserve and organ function level within 7 days before administration must meet the following requirements:
  • 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;
  • Coagulation function: international normalized ratio (INR) ≤ 1.5 × Upper normal value (ULN), active Partial prothrombin time (APTT) ≤ 1.5 × ULN；
  • 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);
  • Renal function: creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 40 ml/min (according to Cockcroft-Gault formula);
  • Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%; ECG is basically normal,QT interval (QTCF) corrected by fridericia formula: male ≤ 450 ms, female ≤ 470 ms；
  • Qualified patients (male and female) with fertility must agree to give drugs during the trial or at the end of the trial Use reliable contraceptive methods (hormone or barrier method or abstinence) with their partners for at least 6 months Etc.); Women of childbearing age (refer to the appendix of the text for the definition) within 7 days before the first use of the investigational drug The pregnancy test must be negative.

Who cannot join

  • Known allergy to, or hypersensitivity to, VIC-1911, osimertinib, or any of the excipient ingredients
  • 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
  • Other side effects caused by previous treatment did not alleviate to CTCAE≤ grade 1, alopecia or otherwise
  • 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
  • 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
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  • Other active infections requiring intravenous antibiotics within 7 days before administration;
  • Use of potent CYP inducer 28 days before administration or within 5 half-lives of the drug, whichever is longer A guide or inhibitor;
  • 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;
  • 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;
  • A history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
  • uncontrolled hypertension (systolic blood pressure >160 mmHg or shu) after standard clinical treatment Tension >100 mmHg for more than 4 weeks); I have severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias that require clinical intervention, Degree II-III atrioventricular block, etc Patients with grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria Any arterial thromboembolic event, including but not limited to myocardial infarction, occurred within 6 months prior to dosing Plug, transient ischemic attack, unstable angina pectoris or other grade 3 or above cardiovascular and cerebrovascular disease Events; Any factor that increases the risk of prolonged QTc intervals or arrhythmias: e.g., heart failure, hypokalemia Haemaemia, congenital long QT syndrome, or the use of anything known to prolong the QT interval Concomitant drugs (see Appendix of the main text for details), except antibiotics used to prevent or treat infection;
  • Parenchymal or meningeal metastases with clinical symptoms were not eligible for inclusion as judged by the investigator. Such as Previous systemic and radical brain metastases therapy (radiotherapy or surgery) proved stable on imaging It has been maintained for at least 28 days and has stopped systemic hormone therapy for more than 14 days without clinical symptoms Is allowed to enter the group;
  • Suffers from hematological malignancies;
  • Other malignant tumors have been diagnosed within 5 years before the first use of the study drug; Effectively treated skin Basal cell carcinoma, squamous cell carcinoma of the skin, and/or effectively resected cervical cancer in situ and/or breast Except the cancer;
  • Inability to swallow medication;
  • Gastrointestinal diseases that may affect the absorption or tolerability of the trial drug, such as refractory or screening CTCAE> grade 2 gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, etc.);
  • Patients with difficulty in venous blood collection;
  • Women who have a positive pregnancy test or are breastfeeding during the screening period;
  • Administration of an investigational drug that has undergone clinical trials of other drugs within 28 days prior to administration;
  • Previous treatment with other Aurora kinase inhibitors;
  • Patients with a history of blood donation or blood loss of more than 400 mL 3 months before screening;
  • Anything else that, in the opinion of the investigator, may affect the subject to provide informed consent or follow the protocol Circumstances, or the subject's participation in the trial may affect the results of the trial or their own safety.

Trial locations and contacts

1 site in 1 country.

li zhang, professor contact

13902282893

zhangli6@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Zhangli

    Guangdong

    li zhang, professor

    Recruiting

Other trials in China

About this study

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

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.

Being tested
VIC-1911, Osimertinib Mesylate Tablets

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VIC-1911Drug

    VIC-1911 tablets for oral administration

  • Osimertinib Mesylate TabletsDrug

    Also called TAGRISSO

    Osimertinib tablets for oral administration

Study groups in NCT05489731
Study groupRoleWhat they receive
Dose escalation phase-Dose group 1 VIC-1911 Tablets with Osimertinib Mesylate TabletsExperimentalAdvanced NSCLC patients who experienced first/second-generation EGFR-TKI failure with T790M mutation negative or who experienced third-generation EGFR-TKI failure and a subsequent platinum-based doublet chemotherapy failure
Receives: Drug: VIC-1911; Drug: Osimertinib Mesylate Tablets
Dose escalation stage - Dose group 2 VIC-1911 Tablets with Osimertinib Mesylate TabletsExperimentalAdvanced NSCLC patients who experienced first/second-generation EGFR-TKI failure with T790M mutation negative or who experienced third-generation EGFR-TKI failure and a subsequent platinum-based doublet chemotherapy failure
Receives: Drug: VIC-1911; Drug: Osimertinib Mesylate Tablets
Dose expansion phase VIC-1911 Tablets with Osimertinib Mesylate TabletsExperimentalCohort 1: NSCLC patients who experienced first/second-generation EGFR-TKI failure with T790M mutation positive; Cohort 2: NSCLC patients who experienced third-generation EGFR-TKI failure
Receives: Drug: VIC-1911; Drug: Osimertinib Mesylate Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment emergent adverse events (safety and tolerability)

    Safety and tolerability assessed by adverse events(AEs) and serious adverse events (SAEs)

    Measured: 36 months

Secondary outcomes (5)

  1. Pharmacokinetic PK parameters

    Cmax

    Measured: C1D1 and C1D4 in the first period

  2. Time to Response

    Length of time from the date of first dose of study drug to the first evidence of objective response (CR,PR)

    Measured: Assessed from the date of the first dose of study drug to the first evidence of disease progression or death, whichever is earlier,Expected to evaluate to 36month

  3. Disease Control Rate

    Proportion of subjects with best response of CR, PR or stable disease (SD)

    Measured: Assessed from the date of the first dose of study drug to the first evidence of disease progression or death, whichever is earlier,Expected to evaluate to 36month

  4. Progression-Free Survival

    Length of time from the date of first dose of study drug to the first evidence of disease progression or death, whichever is earlier

    Measured: Assessed from the date of the first dose of study drug to the first evidence of disease progression or death, whichever is earlier,Expected to evaluate to 36month

  5. Overall Survival

    Length of time from the date of first dose of study drug to date of death from any cause

    Measured: Assessed from the date of the first dose of study drug to the first evidence of disease progression or death, whichever is earlier,Expected to evaluate to 36month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2022
  2. Study start21 Sep 2022
  3. Primary completion24 Feb 2024 (estimated)
  4. Study completion24 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
In the dose escalation phase, a total of 2 groups were planned, and 6-12 patients were expected to be enrolled. In the expansion phase, two cohorts are planned, with each cohort expanding to 20-30 patients, and approximately 40-60 patients are expected to be enrolled. A total of 46 to 72 patients were enrolled in this phase I trial
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05489731
Sponsor's protocol ID
JSI-1911-102
Acronym
VIC-1911
Status last verified
Jun 2023
First submitted
29 Jul 2022
Last updated
15 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VIC-1911 and Osimertinib Mesylate Tablets in people with Advanced Non-small Cell Lung Cancer, run by Jiesi Yingda Pharmaceutical Technology (Suzhou) Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact li zhang, professor (13902282893, zhangli6@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment emergent adverse events (safety and tolerability) (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05489731.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.

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