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Small Molecule

Sotorasib for Solid Cancers

Phase 1

Recruiting

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 performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

Be older than 18 years old

Must not have

Primary brain tumor

Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called sotorasib. It is aimed at adults who have advanced solid tumors with a specific genetic mutation known as KRAS p.G12C. Sotorasib works by blocking this mutation, which can help slow down or stop the growth of the cancer. Sotorasib is the first targeted agent approved for this specific mutation in patients who have previously received treatment.

Who is the study for?

This trial is for adults over 18 with advanced solid tumors that have a specific mutation called KRAS p.G12C. Participants must have their condition confirmed by certain lab tests. People with primary brain tumors, recent heart attacks, or issues that prevent taking oral meds can't join.

What is being tested?

The trial is testing the safety of sotorasib in combination with various cancer treatments like chemotherapy and targeted drugs (atezolizumab, carboplatin, etc.) in patients with a particular genetic change in their tumor cells.

What are the potential side effects?

Potential side effects may include typical reactions to cancer medications such as nausea, fatigue, increased risk of infection due to lowered immunity, allergic reactions to drug components, and possible organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

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

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I have a primary brain tumor.

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I do not have active brain issues related to my cancer.

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I cannot take pills due to a stomach or intestine problem.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Sotorasib Monotherapy Only: Intracranial Disease Control Rate

Sotorasib Monotherapy Only: Intracranial Duration of Response

Sotorasib Monotherapy Only: Intracranial Objective Response Rate

+3 more

Side effects data

From 2022 Phase 1 trial • 20 Patients • NCT04887064

14%

Constipation

100%

80%

60%

40%

20%

Study treatment Arm

Normal Hepatic Function

Moderate Hepatic Impairment

Severe Hepatic Impairment

Awards & Highlights

No Placebo-Only Group

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

Trial Design

14Treatment groups

Experimental Treatment

Group I: Sotorasib MonotherapyExperimental Treatment1 Intervention

Experimental: Sotorasib only Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer with brain metastases. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer with brain metastases.

Group II: Sotorasib + trametinib + panitumumabExperimental Treatment3 Interventions

Experimental: Sotorasib + trametinib + panitumumab Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.

Group III: Sotorasib + pembrolizumabExperimental Treatment2 Interventions

Experimental: Sotorasib + pembrolizumab Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant non small cell lung cancer. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS P.G12C mutant non small cell lung cancer.

Group IV: Sotorasib + panitumumab +/- chemotherapyExperimental Treatment3 Interventions

Experimental: Sotorasib + panitumumab +/- chemotherapy Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.

Group V: Sotorasib + palbociclibExperimental Treatment2 Interventions

Experimental: Sotorasib + palbociclib Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.

Group VI: Sotorasib + everolimusExperimental Treatment2 Interventions

Experimental: Sotorasib + everolimus Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced solid tumor. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumor.

Group VII: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumabExperimental Treatment3 Interventions

Experimental: Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.

Group VIII: Sotorasib + atezolizumabExperimental Treatment2 Interventions

Experimental: Sotorasib + atezolizumab Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.

Group IX: Sotorasib + afatinibExperimental Treatment2 Interventions

Experimental: Sotorasib + afatinib Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C advanced non-small cell lung cancer. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced non-small cell lung cancer.

Group X: Sotorasib + TNO155Experimental Treatment2 Interventions

Experimental: Sotorasib + TNO155 Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors.

Group XI: Sotorasib + RMC-4630Experimental Treatment2 Interventions

Experimental: Sotorasib + RMC-4630 Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants, with KRAS p.G12C mutant advanced solid tumors.

Group XII: Sotorasib + MVASI® (bevacizumab-awwb)+ ChemotherapyExperimental Treatment4 Interventions

Experimental: Sotorasib + MVASI® (bevacizumab-awwb)+ chemotherapy Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer. * Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced colorectal cancer.

Group XIII: Sotorasib + BI 1701963Experimental Treatment2 Interventions

Experimental: Sotorasib + BI 1701963 Dose Exploration and Dose Expansion * Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. * Upon completion of dose exploration part of the study the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced non-small cell lung cancer and advanced colorectal cancer.

Group XIV: Sotorasib + AMG 404Experimental Treatment2 Interventions

Experimental: Sotorasib + AMG 404 Dose Exploration and Dose Expansion • Enrollment into the dose exploration cohort is for eligible participants with KRAS P.G12C mutant advanced solid tumors. • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of participants with KRAS p.G12C mutant advanced solid tumors

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trametinib

2014

Completed Phase 2

~1630

BI 1701963

2021

Completed Phase 1

~10