VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer

Part of paid clinical trials in Sacramento, California.

Sponsor
Vitrac Therapeutics, LLC
Study ID
NCT05374538
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VIC-1911 — DRUG
    VIC-1911 tablets for oral administration
  • sotorasib — DRUG
    Sotorasib tablets for oral administration

Study Details

This is a Phase 1a/1b 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).

Key Dates

Start date
Nov 9, 2022
Status verified
Mar 2025
Primary completion
Aug 26, 2023
Completion
Aug 26, 2023

Study Design

Enrollment
3 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Phase, Cohort 1a: VIC-1911 monotherapy
    Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
  • Experimental: Dose Escalation Phase, Cohort 1b: VIC-1911 plus sotorasib combination therapy
    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. Only Dose Level 1 was opened and all 3 subjects received sotorasib 960 mg QD PO, VIC-1911 75 mg BID PO.
  • Experimental: Expansion Phase, Cohort 2a: VIC-1911 monotherapy
    Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
  • Experimental: Expansion Phase, Cohort 2b: VIC-1911 plus sotorasib combination therapy
    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.
  • Experimental: Expansion Phase, Cohort 2c: VIC-1911 plus sotorasib combination therapy
    Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.

Primary Outcome Measure

Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 9 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of California DavisSacramentoCalifornia95817-
Yale Cancer CenterNorth HavenConnecticut06473-
Emory University Winship Cancer CenterAtlantaGeorgia30322-
University of Maryland Cancer CenterBaltimoreMaryland21201-
New York University Langone Health Perlmutter Cancer CancerNew YorkNew York10016-

Related coverage on Hipa.ai

Find similar trials in Sacramento, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of California Davis· Sacramento, CAYale Cancer Center· North Haven, CTEmory University Winship Cancer Center· Atlanta, GAUniversity of Maryland Cancer Center· Baltimore, MDNew York University Langone Health Perlmutter Cancer Cancer· New York, NY

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