VS-6766 and adagrasib for Metastatic Cancers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Metastatic Cancers+9 More
VS-6766 and adagrasib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study a new combination therapy for patients with lung cancer who have progressed despite previous treatment with a similar drug.

Eligible Conditions
  • Metastatic Cancers
  • Malignant Neoplasms
  • Malignant Neoplastic Disease
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • KRAS Activating Mutation
  • Cancer, Advanced

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

3 Primary · 13 Secondary · Reporting Duration: Up to 5 years

10 weeks
Plasma Pharmacokinetics (PK) of Avutometinib(VS 6766), adagrasib, and relevant metabolites - AUC
Plasma Pharmacokinetics (PK) of Avutometinib(VS 6766), adagrasib, and relevant metabolites - Half-life
Plasma Pharmacokinetics (PK) of Avutometinib(VS 6766), adagrasib, and relevant metabolites - Tmax
Plasma Pharmacokinetics (PK) of VS 6766, adagrasib, and relevant metabolites - AUC
Plasma Pharmacokinetics (PK) of VS 6766, adagrasib, and relevant metabolites - Half-life
Plasma Pharmacokinetics (PK) of VS 6766, adagrasib, and relevant metabolites - Tmax
24 Months
To characterize the safety and toxicity profile
24 months
ECG QT Interval
Progression Free Survival (PFS)
Day 28
Part A: To determine RP2D for Avutometinib(VS-6766) in combination with adagrasib
Part A: To determine RP2D for VS-6766 in combination with adagrasib
Week 16
To determine the efficacy of the optimal regimen identified from Part A
Week 8
Disease Control Rate (DCR)
Month 6
Duration of Response (DOR)
Up to 5 years
Overall Survival (OS)
≥ 6 months
Clinical Benefit Rate

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

4 Treatment Groups

Avutometinib(VS-6766)+adagrasib
1 of 4
Avutometinib (VS-6766)+adagrasib RP2D
1 of 4
VS-6766+adagrasib
1 of 4
VS-6766+adagrasib RP2D
1 of 4

Experimental Treatment

85 Total Participants · 4 Treatment Groups

Primary Treatment: VS-6766 and adagrasib · No Placebo Group · Phase 1 & 2

Avutometinib(VS-6766)+adagrasib
Drug
Experimental Group · 1 Intervention: Avutometinib (VS-6766) and adagrasib · Intervention Types: Drug
Avutometinib (VS-6766)+adagrasib RP2D
Drug
Experimental Group · 1 Intervention: Avutometinib (VS-6766) and adagrasib · Intervention Types: Drug
VS-6766+adagrasib
Drug
Experimental Group · 1 Intervention: VS-6766 and adagrasib · Intervention Types: Drug
VS-6766+adagrasib RP2D
Drug
Experimental Group · 1 Intervention: VS-6766 and adagrasib · Intervention Types: Drug

Trial Logistics

Trial Timeline

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

Who is running the clinical trial?

Mirati Therapeutics Inc.Industry Sponsor
58 Previous Clinical Trials
6,387 Total Patients Enrolled
4 Trials studying Metastatic Cancers
926 Patients Enrolled for Metastatic Cancers
Verastem, Inc.Lead Sponsor
31 Previous Clinical Trials
1,858 Total Patients Enrolled
2 Trials studying Metastatic Cancers
123 Patients Enrolled for Metastatic Cancers
Hagop Youssoufian, MDStudy DirectorVerastem, Inc.
24 Previous Clinical Trials
1,582 Total Patients Enrolled
2 Trials studying Metastatic Cancers
123 Patients Enrolled for Metastatic Cancers

Eligibility Criteria

Age 18+ · All Participants · 10 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.
The subject must have received prior therapy with a KRAS G12C inhibitor and experienced progression.
You have received at least one prior systemic treatment for Stage 3B-C or Stage 4 NSCLC, but no more than three prior systemic regimens.
You have adequate organ function.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: November 1st, 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.