Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05200442 | A Study of VS-6766 and Cetuximab in Patients With Advanced Colorectal Cancer | PHASE1 | RECRUITING | 53 | — | — | Aug 22, 2022 | Feb 1, 2027 | Nov 5, 2025 | 1 | United States |
The maximum tolerated dose of VS-6766 in combination with cetuximab in participants who have KRAS-mutated metastatic colorectal cancer after disease progression or evidence of intolerance to fluorouracil (5- FU) /capecitabine, oxaliplatin, irinotecan and bevacizumab (if indicated). Doctors leading the study will find the maximum tolerated dose by assessing the rate of serious side effects (known as "dose limiting toxicities") among participants according to the NCI Common Terminology Criteria (CTCAE) for Adverse Events Version 5.
Objective response rate or participants who take the maximum tolerated dose (MTD) of VS-6766 combined with cetuximab that was established in phase 1 (the dose-finding portion) of the study. The objective response rate (how the participant's cancer responds to the study drugs) will be measured and assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| Phase 1(Dose-Finding Arm): Group 1 - Dose Level 1 (Starting Dose) | EXPERIMENTAL | 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. |
| Phase 1(Dose-Finding Arm): Group 2- Dose Level 2 (Second Highest Dose) | EXPERIMENTAL | 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. |
| Phase 1(Dose-Finding Arm): Group 3 - Lower Dose Level 1 | EXPERIMENTAL | 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 |
| Phase 1(Dose-Finding Arm): Group 4 - Lower Dose Level 2 | EXPERIMENTAL | 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 |
| Phase 2 (Efficacy Arm/ Expansion Cohort) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Must be able to show documentation of disease: Participants must have metastatic colorectal adenocarcinoma with kirsten rat sarcoma viral oncogene homolog (KRAS) mutations, detected by any Clinical Laboratory Improvement Amendments-certified method (tumor or ct-DNA), for which...