← Back to Search

Small Molecule

Sotorasib for Solid Tumors

Denver, CO

Phase 1 & 2

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologically documented, locally-advanced or metastatic malignancy with KRAS p.G12C mutation identified through molecular testing

Be older than 18 years old

Must not have

Active brain metastases from non-brain tumors

Gastrointestinal (GI) tract disease causing the inability to take oral medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to study the safety and effectiveness of a new drug, sotorasib, for treating adults with KRAS p.G12C mutant advanced solid tumors.

See full description

Who is the study for?

Adults over 18 with advanced solid tumors that have a specific KRAS p.G12C mutation can join this trial. They must be able to take oral medication and should not have active brain metastases from non-brain tumors or a recent heart attack within the past six months.Check my eligibility

What is being tested?

The trial is testing Sotorasib's safety and how well it works in treating solid tumors with the KRAS mutation. It will also determine the highest dose patients can tolerate without severe side effects, as well as an optimal phase 2 dose.See study design

What are the potential side effects?

Possible side effects of Sotorasib may include fatigue, diarrhea, liver issues, cough, and shortness of breath. The severity of these side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My cancer is advanced or has spread, and tests show a KRAS p.G12C mutation.

show original

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have brain metastases not originating from a brain tumor.

show original

Select...

I cannot take pills due to my GI condition.

show original

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary: Disease control as assessed by RECIST 1.1 criteria

Primary: Duration of response (DOR) as assessed by RECIST 1.1 criteria

Primary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria

+12 more

Secondary study objectives

Secondary: Area under the plasma concentration-time curve (AUC) of midazolam

Secondary: Area under the plasma concentration-time curve (AUC) of sotorasib

Secondary: Change from baseline in physical function as assessed by EORTC QLQ-C30

+27 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Phase 2 monotherapy dose comparisonExperimental Treatment1 Intervention

Subjects with NSCLC will be enrolled in a dose comparison study evaluating safety and efficacy

Group II: Phase 1 monotherapy treatment naive advanced NSCLCExperimental Treatment2 Interventions

Separate cohort of part 1 dose expansion subjects to evaluate the safety and clinical activity of sotorasib administered orally once daily in subjects with previously untreated advanced non-small cell lung cancer (NSCLC). Drug-drug interaction will be evaluated in 6 of the subjects enrolled in the treatment naive cohort by adding Midazolam alone on Day -1 and in combination with sotorasib on Day 15 of Cycle 1, where each cycle is 21 days.

Group III: Phase 1 combination arm with sotorasib and anti PD-1/L1Experimental Treatment2 Interventions

Additional subjects will be enrolled into the combination arm with sotorasib in combination with an anti (PD-1/L1)

Group IV: Phase 1 Dose Exploration Part 1 monotherapyExperimental Treatment1 Intervention

Cohorts with food effect and alternative dosing regimens Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 2-4 subjects treated at the lowest planned dose level of 180 mg. If no DLT is observed, dose escalation will continue to the next planned dose cohort

Group V: Phase 1 Dose Expansion Part 2 monotherapyExperimental Treatment1 Intervention

Upon completing the dose exploration part of the study, dose expansion may proceed with 3 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors. Dose expansion in these 3 groups may be done concurrently

Group VI: Phase 1 Does escalation and Expansion monotherapy BIDExperimental Treatment1 Intervention

BID 2L+solid tumors (fed state)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Midazolam

2018

Completed Phase 4

~1910

0 / 3Eligibility criteria met