A Study of VS-6766 and Cetuximab in Patients With Advanced Colorectal Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT05200442
Phase
PHASE1/PHASE2
Status
Suspended

Conditions

  • Advanced Colorectal Adenocarcinoma
  • Advanced Colorectal Carcinoma
  • Colorectal Adenocarcinoma
  • Colorectal Cancer
  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

  • VS-6766/avutometinib — DRUG
    An oral anti-cancer medication.
  • Cetuximab — DRUG
    A chemotherapy drug used to treat head, neck and colorectal cancer.
  • Pill Diary — OTHER
    A diary where participants in phase 2 of study will log their medications and times they are taken on study.

Study Details

Doctors leading this study hope to learn about the safety of combining the study drug VS-6766 with another drug called cetuximab in colorectal cancer. This study is for individuals who have advanced colorectal cancer and their cancer has progressed while getting previous treatment or individuals who cannot take/tolerate previous treatments. If you choose to participate, your time in this research will last up to 24 months.

Key Dates

Start date
Aug 22, 2022
Status verified
May 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
53 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1(Dose-Finding Arm): Group 1 - Dose Level 1 (Starting Dose)
    This study will use two dose levels (a starting dose at level 1 and a second dose highest dose at level 2) of the VS-6766 and cetuximab regimen. If participants in group 1 don't experience severe negative side effects to the starting dose of the regimen, then more participants will be assigned to group 2 at a higher dose until the safest/ most tolerable dose is found. If participants show toxic side effects to the first pre-determined dose, the dose will be decreased to the next lower dose level. Group 1/ Dose Level 1: Participants in group 0 will receive the starting dose of study drugs (below): * VS-6766 (2.4mg) orally twice a week * cetuximab (500mg) via intravenous (IV) needle in vein every 2 weeks During phase 1, VS-6766 and cetuximab will be given in 28-day "cycles" (a period of time when participants receive study drugs). Participants in this portion of the study will receive 12 cycles of VS-6766 and cetuximab.
  • Experimental: Phase 1(Dose-Finding Arm): Group 2- Dose Level 2 (Second Highest Dose)
    This study will use two dose levels (a starting dose at level 1 and a second dose highest dose at level 2) of the VS-6766 and cetuximab regimen. If participants in group 1 don't experience severe negative side effects to the starting dose of the regimen, then more participants will be assigned to group 2 at a higher dose until the safest/ most tolerable dose is found. If participants show toxic side effects to the first pre-determined dose, the dose will be decreased to the next lower dose level. Participants in group 2 will receive the second highest dose of study drugs (below): * VS-6766 (3.4mg) orally twice a week * cetuximab (500mg) via intravenous (IV) needle in vein every 2 weeks During phase 1, VS-6766 and cetuximab will be given in 28-day "cycles" (a period of time when participants receive study drugs). Participants in this portion of the study will receive 12 cycles of VS-6766 and cetuximab.
  • Experimental: Phase 1(Dose-Finding Arm): Group 3 - Lower Dose Level 1
    Participants in this group will received a lower dose of the VS6766 and cetuximab regimen. Inclusion in this group is optional and based on whether the participant reports serious side effects in response to a higher dose of the regimen. If participants are included in this group, they will receive: * VS-6766 (2.4mg) orally twice a week * cetuximab (400mg) via intravenous (IV) needle in vein every 2 weeks
  • Experimental: Phase 1(Dose-Finding Arm): Group 4 - Lower Dose Level 2
    Participants in this group will received the second lowest dose of the VS6766 and cetuximab regimen. Inclusion in this group is optional and based on whether the participant reports serious side effects in response to a higher dose of the regimen. If participants are included in this group, they will receive: * VS-6766 (2.4mg) orally twice a week * cetuximab (300mg) via intravenous (IV) needle in vein every 2 weeks
  • Experimental: Phase 2 (Efficacy Arm/ Expansion Cohort)
    Participants in this arm will help test the efficacy of the VS-6766 and cetuximab dose established in phase 1 of the study. Participants will take the same two drugs ( VS-6766 and cetuximab) at the best tolerated dose that was found during the first phase of the study. Participants in this group will also keep a pill diary. This helps you keep track of when you take your pills. The study team at your doctor's office will show you how to use this diary. Each time you visit the clinic, you must bring the pill diary, any remaining pills, and the pill bottle.

Primary Outcome Measure

Phase I Primary Objective: Maximum Tolerated Dose (MTD) of VS-6766 combined with Cetuximab [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60615-

Find similar trials in Chicago, IL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of Chicago Medical Center· Chicago, IL

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