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Small Molecule

Sotorasib for Solid Tumors

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study 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.

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,370 Previous Clinical Trials

1,376,975 Total Patients Enrolled

MDStudy DirectorAmgen

913 Previous Clinical Trials

923,418 Total Patients Enrolled

Media Library

Sotorasib (AMG 510) (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT03600883 — Phase 1 & 2

Solid Tumors Research Study Groups: Phase 1 Does escalation and Expansion monotherapy BID, Phase 1 Dose Expansion Part 2 monotherapy, Phase 1 combination arm with sotorasib and anti PD-1/L1, Phase 1 monotherapy treatment naive advanced NSCLC, Phase 2 monotherapy dose comparison, Phase 1 Dose Exploration Part 1 monotherapy

Solid Tumors Clinical Trial 2023: Sotorasib (AMG 510) Highlights & Side Effects. Trial Name: NCT03600883 — Phase 1 & 2

Sotorasib (AMG 510) (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03600883 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what medical indications is AMG 510 typically administered?

"AMG 510 is commonplace in therapeutic procedures, but also has applications for central nervous system depressants, preoperative sedation and anaesthesia treatment."

Answered by AI

How many people have elected to participate in this research initiative?

"Unfortunately, this trial is no longer actively recruiting. Initially posted in August of 2018 and last updated on November 14th 2022, the study has since ended. However, there are 2380 other trials that accept patients with cancer and 75 specific to AMG 510 which are still open for enrollment."

Answered by AI

How many clinical sites are currently carrying out this research program?

"The trial is being conducted in multiple sites, with the primary locations at Massachusetts General Hospital (Boston), University of Texas Southwestern Medical Center (Dallas) and Texas Oncology Austin Central (Austin). An additional forty-five other centres are also participating."

Answered by AI

What is the overarching aim of this clinical experimentation?

"The primary objective of this clinical trial, which is to be observed over the span of 2 years, will monitor for adverse events resulting from treatment. Additionally, secondary goals such as plasma concentration (Cmax) and area under the curve (AUC) of AMG 510 across various patient groups will also be recorded in order to assess efficacy."

Answered by AI

What prior research has been conducted on AMG 510?

"First observed by Shaare Zedek Medical Center in 2009, AMG 510 has since been the subject of 563 studies. Currently, 75 trials are active around the world with a handful taking place within Boston's borders."

Answered by AI

What criteria must be met to participate in this trial?

"This clinical trial is in search of 713 individuals with cancer between the ages 18 and 100 who meet qualifications such as: male or female, over eighteen years old."

Answered by AI

Does the age cutoff for this experiment preclude those under 55 years old?

"This clinical trial is accessible to those aged 18 - 100. There are 325 trials for minors and 2244 for elderly patients in this same study area."

Answered by AI

Are there any available openings to participate in this investigation?

"The clinicaltrials.gov record suggests that this trial is not currently recruiting participants; it was first posted on August 27th 2018 and last updated November 14th 2022. Although this study has closed its recruitment phase, there are 2455 other studies looking for patients right now."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Krasg12c Inhibition with Sotorasib in Advanced Solid Tumors

Hong, David S., Marwan G. Fakih, John H. Strickler, Jayesh Desai, Gregory A. Durm, Geoffrey I. Shapiro, Gerald S. Falchook, et al.. 2020. “Krasg12c Inhibition with Sotorasib in Advanced Solid Tumors”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1917239.

NatureJournal

The Clinical KRAS(G12C) Inhibitor AMG 510 Drives Anti-tumour Immunity

Canon, Jude, Karen Rex, Anne Y. Saiki, Christopher Mohr, Keegan Cooke, Dhanashri Bagal, Kevin Gaida, et al.. 2019. “The Clinical KRAS(G12C) Inhibitor AMG 510 Drives Anti-tumour Immunity”. Nature. Springer Science and Business Media LLC. doi:10.1038/s41586-019-1694-1.

krasJournal

Sotorasib for Lung Cancers with kras P.g12c Mutation

Skoulidis, Ferdinandos, Bob T. Li, Grace K. Dy, Timothy J. Price, Gerald S. Falchook, Jürgen Wolf, Antoine Italiano, et al.. 2021. “Sotorasib for Lung Cancers with kras P.g12c Mutation”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2103695.

Journal of Medicinal ChemistryJournal