Clinical trial NCT05200442: A Study of VS-6766 and Cetuximab in Patients With Advanced Colorectal Cancer
Official title: A Phase 1b/2 Study of AVUTOMETINIB and Cetuximab in Participants With Advanced KRAS Mutated Colorectal Cancer
Conditions: Colorectal Cancer
Colorectal Adenocarcinoma
Colorectal Cancer Metastatic
Advanced Colorectal Carcinoma
Advanced Colorectal Adenocarcinoma
Summary: 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.
Interventions:
description: An oral anti-cancer medication.
name: VS-6766/avutometinib
type: Drug
description: A chemotherapy drug used to treat head, neck and colorectal cancer.
name: Cetuximab
other_name: Erbitux
type: Drug
description: A diary where participants in phase 2 of study will log their medications and times they are taken on study.
name: Pill Diary
type: Other
Study arms:
design_group_description: 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.<br/>Group 1/ Dose Level 1:<br/>Participants in group 0 will receive the starting dose of study drugs (below):<br/>* VS-6766 (2.4mg) orally twice a week<br/>* cetuximab (500mg) via intravenous (IV) needle in vein every 2 weeks<br/>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.
design_group_title: Phase 1(Dose-Finding Arm): Group 1 - Dose Level 1 (Starting Dose)
design_group_type: Experimental
design_group_description: 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.<br/>Participants in group 2 will receive the second highest dose of study drugs (below):<br/>* VS-6766 (3.4mg) orally twice a week<br/>* cetuximab (500mg) via intravenous (IV) needle in vein every 2 weeks<br/>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.
design_group_title: Phase 1(Dose-Finding Arm): Group 2- Dose Level 2 (Second Highest Dose)
design_group_type: Experimental
design_group_description: 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.<br/>If participants are included in this group, they will receive:<br/>* VS-6766 (2.4mg) orally twice a week<br/>* cetuximab (400mg) via intravenous (IV) needle in vein every 2 weeks
design_group_title: Phase 1(Dose-Finding Arm): Group 3 - Lower Dose Level 1
design_group_type: Experimental
design_group_description: 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.<br/>If participants are included in this group, they will receive:<br/>* VS-6766 (2.4mg) orally twice a week<br/>* cetuximab (300mg) via intravenous (IV) needle in vein every 2 weeks
design_group_title: Phase 1(Dose-Finding Arm): Group 4 - Lower Dose Level 2
design_group_type: Experimental
design_group_description: 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.<br/>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.
design_group_title: Phase 2 (Efficacy Arm/ Expansion Cohort)
design_group_type: Experimental
Sponsor: The University of Chicago
Collaborators: Verastem, Inc.
Drug name mappings:
name: 西妥昔单抗
lang: CN
name: Cetuximab
lang: EN
name: セツキシマブ（遺伝子組換え）
lang: JP
name: Avutometinib
lang: EN