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

Sponsor
Jiesi Yingda Pharmaceutical Technology (Suzhou) Co., Ltd.
Study ID
NCT05489731
Phase
PHASE1
Status
Unknown

Conditions

  • Advanced Non-small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 21, 2022
Status verified
Jun 2023
Primary completion
Feb 24, 2024
Completion
Apr 24, 2024

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation phase-Dose group 1 VIC-1911 Tablets with Osimertinib Mesylate Tablets
    Advanced 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
  • Experimental: Dose escalation stage - Dose group 2 VIC-1911 Tablets with Osimertinib Mesylate Tablets
    Advanced 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
  • Experimental: Dose expansion phase VIC-1911 Tablets with Osimertinib Mesylate Tablets
    Cohort 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

Primary Outcome Measure

Incidence of treatment emergent adverse events (safety and tolerability) [ Time Frame: 36 months ]

Central Contacts

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