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KRAS G12C Inhibitor
VIC-1911 for Lung Cancer
Phase 1
Waitlist Available
Research Sponsored by Vitrac Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug, VIC-1911, alone and with sotorasib, for adults with a specific type of lung cancer that hasn't responded to other treatments. VIC-1911 works by stopping cancer cells from dividing, and sotorasib targets a specific mutation in the cancer cells. Sotorasib was the first targeted agent with regulatory approval for KRAS G12C-mutated NSCLC.
Eligible Conditions
- Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 42 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of treatment emergent adverse events (safety and tolerability)
Secondary study objectives
Disease Control Rate
Duration of Response
Objective Response Rate
+3 moreOther study objectives
Circulating tumor DNA (ctDNA) in plasma (pharmacodynamic endpoint)
Effect of de novo versus acquired resistance to KRASG12C inhibitor therapy, in subjects refractory to or relapsed on prior KRAS G12C inhibitor therapy
Mean plasma concentrations of VIC-1911 alone and in combination with sotorasib
+1 moreSide effects data
From 2022 Phase 1 trial • 20 Patients • NCT0488706414%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Normal Hepatic Function
Moderate Hepatic Impairment
Severe Hepatic Impairment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Expansion Phase, Cohort 2c: VIC-1911 plus sotorasib combination therapyExperimental Treatment2 Interventions
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
Group II: Expansion Phase, Cohort 2b: VIC-1911 plus sotorasib combination therapyExperimental Treatment2 Interventions
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
Group III: Expansion Phase, Cohort 2a: VIC-1911 monotherapyExperimental Treatment1 Intervention
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
Group IV: Dose Escalation Phase, Cohort 1b: VIC-1911 plus sotorasib combination therapyExperimental Treatment2 Interventions
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy or are naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
Group V: Dose Escalation Phase, Cohort 1a: VIC-1911 monotherapyExperimental Treatment1 Intervention
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
Find a Location
Who is running the clinical trial?
WestatOTHER
45 Previous Clinical Trials
37,851 Total Patients Enrolled
Vitrac Therapeutics, LLCLead Sponsor
Linda J Paradiso, DVMStudy DirectorVitrac Therapeutics, LLC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have noticeable symptoms of cancer spreading to your brain or spinal cord.You have digestive problems that could make it difficult for your body to properly absorb or tolerate the study drugs.You have had a serious infection that required intravenous antibiotics within the past week before starting the study treatment.You have been treated with drugs that target MEK or EGFR in the past.You are allergic to VIC-1911 or any of its ingredients.You are unable to swallow pills or other oral medications.You have a lung condition that is causing symptoms and needs medical treatment.You have participated in or dropped out of a study testing a drug that inhibits aurora kinase A in the past.You cannot take any medications that affect UDP-glucuronosyltransferases (UGTs) during the initial phase of the study.You have had eye problems in the past that caused blurry vision or if a recent eye exam shows any important issues.
Research Study Groups:
This trial has the following groups:- Group 1: Expansion Phase, Cohort 2c: VIC-1911 plus sotorasib combination therapy
- Group 2: Dose Escalation Phase, Cohort 1b: VIC-1911 plus sotorasib combination therapy
- Group 3: Dose Escalation Phase, Cohort 1a: VIC-1911 monotherapy
- Group 4: Expansion Phase, Cohort 2a: VIC-1911 monotherapy
- Group 5: Expansion Phase, Cohort 2b: VIC-1911 plus sotorasib combination therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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