Expansion Phase, Cohort 2a: VIC-1911 monotherapy for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California Davis, Sacramento, CA
Lung Cancer+2 More
sotorasib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 1 study of aurora kinase A inhibitor VIC-1911 administered as monotherapy and in combination with sotorasib for the treatment of locally advanced or metastatic KRAS G12C-mutant non-small cell lung cancer(NSCLC).

Eligible Conditions

  • Lung Cancer
  • Non-small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 42 months

42 months
Effect of de novo versus acquired resistance to KRASG12C inhibitor therapy, in subjects refractory to or relapsed on prior KRAS G12C inhibitor therapy
Incidence of treatment emergent adverse events (safety and tolerability)
Month 6
Disease Control Rate
Duration of Response
Objective Response Rate
Time to Response
Month 42
Overall Survival
Month 42
Progression-Free Survival
Day 4
Circulating tumor DNA (ctDNA) in plasma (pharmacodynamic endpoint)
Day 28
Mean plasma concentrations of VIC-1911 alone and in combination with sotorasib
Day 3
Tumor biopsies for biomarker assessment (pharmacodynamic endpoint)

Trial Safety

Safety Progress

1 of 3

Trial Design

5 Treatment Groups

Expansion Phase, Cohort 2a: VIC-1911 monotherapy
1 of 5
Expansion Phase, Cohort 2b: VIC-1911 plus sotorasib combination therapy
1 of 5
Dose Escalation Phase, Cohort 1a: VIC-1911 monotherapy
1 of 5
Dose Escalation Phase, Cohort 1b: VIC-1911 plus sotorasib combination therapy
1 of 5
Expansion Phase, Cohort 2c: VIC-1911 plus sotorasib combination therapy
1 of 5
Experimental Treatment

140 Total Participants · 5 Treatment Groups

Primary Treatment: Expansion Phase, Cohort 2a: VIC-1911 monotherapy · No Placebo Group · Phase 1

Expansion Phase, Cohort 2a: VIC-1911 monotherapy
Drug
Experimental Group · 1 Intervention: VIC-1911 · Intervention Types: Drug
Expansion Phase, Cohort 2b: VIC-1911 plus sotorasib combination therapyExperimental Group · 2 Interventions: sotorasib, VIC-1911 · Intervention Types: Drug, Drug
Dose Escalation Phase, Cohort 1a: VIC-1911 monotherapy
Drug
Experimental Group · 1 Intervention: VIC-1911 · Intervention Types: Drug
Dose Escalation Phase, Cohort 1b: VIC-1911 plus sotorasib combination therapyExperimental Group · 2 Interventions: sotorasib, VIC-1911 · Intervention Types: Drug, Drug
Expansion Phase, Cohort 2c: VIC-1911 plus sotorasib combination therapyExperimental Group · 2 Interventions: sotorasib, VIC-1911 · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 42 months
Closest Location: University of California Davis · Sacramento, CA
Photo of Sacramento  1Photo of Sacramento  2Photo of Sacramento  3
2006First Recorded Clinical Trial
0 TrialsResearching Lung Cancer
75 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Cohort 2c: Locally advanced or metastatic NSCLC refractory to or relapsed on at least 1 prior cancer therapy as noted above, and naïve to KRAS G12C inhibitor therapy.
You have measurable disease by RECIST 1.1.
You have received at least 1 prior line of cancer therapy with a PD-1 or PD-L1 inhibitor with or without platinum-based chemotherapy.
You are at least 18 years of age.
You have locally advanced or metastatic NSCLC, KRAS G12C-mutated.
The presence of a KRAS G12C mutation should be established prior to entry as assessed in a CLIA qualified laboratory

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.