NCT05489731

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Jiesi Yingda Pharmaceutical Technology (Suzhou) Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	VIC-1911	VIC-1911 tablets for oral administration
DRUG	Osimertinib Mesylate Tablets	Osimertinib tablets for oral administration

Timeline

• Start date: 2022-09-21
• Primary completion: 2024-02-24
• Completion: 2024-04-24
• First posted: 2022-08-05
• Last updated: 2023-06-15

Locations

1 site across 1 country: China