VS-6766 for KRAS Activating Mutation

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
KRAS Activating Mutation+3 More
VS-6766 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether a new drug is safe and effective for treating Non-small cell lung cancer that has come back.

Eligible Conditions
  • KRAS Activating Mutation
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Study Objectives

6 Primary · 7 Secondary · Reporting Duration: Up to 5 years

24 weeks
Non-Small Cell Lung Carcinoma
Week 24
Overall Response Rate as assessed by Investigator
Overall Response Rate per RECIST 1.1 as assessed by Investigator
Part A: To determine the optimal regimen, either VS-6766 monotherapy or VS-6766 in combination with defactinib
Part B: To determine the efficacy of the optimal regimen identified from Part A
To determine efficacy in KRAS-other (non-G12V) NSCLC
To determine the efficacy of VS-6766 in combination with defactinib in BRAF-MT NSCLC
To determine the optimal regimen, either VS-6766 monotherapy or VS-6766 in combination with defactinib, in KRAS-G12V NSCLC
To evaluate the initial efficacy of VS-6766 in combination with defactinib in BRAF-MT NSCLC
Week 8
Disease Control Rate (DCR)
Month 6
Duration of Response (DOR)
Up to 5 years
Overall Survival (OS)
Progression Free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

7 Treatment Groups

Part B
1 of 7
Arm 2: VS-6766 in combination with defactinib
1 of 7
Arm 4: VS-6766 in combination with defactinib
1 of 7
Part A
1 of 7
Arm 1: VS-6766 monotherapy
1 of 7
Arm 5: VS-6766 in combination with defactinib
1 of 7
Arm 3: VS-6766 in combination with defactinib
1 of 7

Experimental Treatment

100 Total Participants · 7 Treatment Groups

Primary Treatment: VS-6766 · No Placebo Group · Phase 2

Part BExperimental Group · 2 Interventions: VS-6766, VS-6766 and Defactinib · Intervention Types: Drug, Drug
Arm 2: VS-6766 in combination with defactinib
Drug
Experimental Group · 1 Intervention: VS-6766 and Defactinib · Intervention Types: Drug
Arm 4: VS-6766 in combination with defactinib
Drug
Experimental Group · 1 Intervention: VS-6766 and Defactinib · Intervention Types: Drug
Part AExperimental Group · 2 Interventions: VS-6766, VS-6766 and Defactinib · Intervention Types: Drug, Drug
Arm 1: VS-6766 monotherapy
Drug
Experimental Group · 1 Intervention: VS-6766 · Intervention Types: Drug
Arm 5: VS-6766 in combination with defactinib
Drug
Experimental Group · 1 Intervention: VS-6766 and Defactinib · Intervention Types: Drug
Arm 3: VS-6766 in combination with defactinib
Drug
Experimental Group · 1 Intervention: VS-6766 and Defactinib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VS-6766
2021
Completed Phase 1
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Verastem, Inc.Lead Sponsor
31 Previous Clinical Trials
1,843 Total Patients Enrolled
2 Trials studying KRAS Activating Mutation
138 Patients Enrolled for KRAS Activating Mutation
Hagop Youssoufian, MDStudy DirectorVerastem, Inc.
24 Previous Clinical Trials
1,567 Total Patients Enrolled
2 Trials studying KRAS Activating Mutation
138 Patients Enrolled for KRAS Activating Mutation
Ross Camidge, MD, PhDPrincipal InvestigatorUniversity of Colorado, Denver

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female, and you are at least 18 years of age.
You have adequate organ function.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.