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Small Molecule

Sotorasib for Solid Cancers

Phase 1 & 2
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.
Men or women greater than or equal to 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new drug, sotorasib, to see if it is safe and effective in treating adults with KRAS p.G12C mutant advanced solid tumors.

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.Check my eligibility
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.See study design
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
Select...
My cancer is advanced or has spread, and tests show a KRAS mutation.
Select...
I am 18 years old or older.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1b: Number of Participants with Clinically Significant Changes in ECG Measurements
Phase 1b: Number of Participants with Clinically Significant Changes in Laboratory Test Values
Phase 1b: Number of Participants with Clinically Significant Changes in Vital Signs
+4 more
Secondary outcome measures
Phase 1b: Area Under the Plasma Concentration-time Curve (AUC)
Phase 1b: Disease Control Rate
Phase 1b: Duration of Response
+32 more

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
~1600
Panitumumab
2020
Completed Phase 3
~6490
Palbociclib
2017
Completed Phase 3
~3710
Afatinib
2016
Completed Phase 4
~2340
Atezolizumab
2016
Completed Phase 3
~6040
Everolimus
2010
Completed Phase 4
~1510
Pembrolizumab
2017
Completed Phase 2
~2010
BI 1701963
2021
Completed Phase 1
~10
Sotorasib
2021
Completed Phase 1
~370
AMG 404
2020
Completed Phase 1
~230
RMC-4630
2019
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,362 Previous Clinical Trials
1,384,145 Total Patients Enrolled
MDStudy DirectorAmgen
904 Previous Clinical Trials
921,640 Total Patients Enrolled

Media Library

Sotorasib (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04185883 — Phase 1 & 2
Solid Tumors Research Study Groups: Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy, Sotorasib + panitumumab +/- chemotherapy, Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab, Sotorasib + trametinib + panitumumab, Sotorasib + afatinib, Sotorasib + palbociclib, Sotorasib + BI 1701963, Sotorasib + AMG 404, Sotorasib Monotherapy, Sotorasib + atezolizumab, Sotorasib + TNO155, Sotorasib + pembrolizumab, Sotorasib + everolimus, Sotorasib + RMC-4630
Solid Tumors Clinical Trial 2023: Sotorasib Highlights & Side Effects. Trial Name: NCT04185883 — Phase 1 & 2
Sotorasib (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04185883 — Phase 1 & 2

Frequently Asked Questions

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

Is the trial open to senior citizens?

"Only individuals between the ages 18 and 100 can enroll in this medical trial, while 634 studies are available to minors and 5448 trials accommodate seniors."

Answered by AI

Are individuals still able to join this research endeavor?

"Confirmed. Records found on clinicaltrials.gov reveal that this medical research, first posted in December of 2019 is still recruiting patients nationwide. 1054 participants are expected to be enrolled across 52 locations before the study's completion date of September 1st 2022."

Answered by AI

How many healthcare facilities are hosting this clinical investigation?

"A plethora of medical sites are available for this study, such as Texas Oncology-Tyler in Tyler, Texas Oncology-Tyler in Quebec, and CHU de Quebec Hopital de l Enfant Jesus in Fairfax. In total, 52 different locations have been identified and approved by the research team."

Answered by AI

Who qualifies to partake in this trial?

"This medical trial is calling for 1054 people with cancer aged 18-100 years. Criteria to be met by applicants include: both male and female candidates of the legal age, a biopsy-confirmed diagnosis of advanced or metastasised malignancy, and KRAS p.G12C mutation detected via molecular testing that must abide by US regulations (i.e., conducted in CLIA certified laboratories)."

Answered by AI

How many people have enrolled in this clinical experiment?

"This medical study necessitates the participation of 1054 individuals that meet its criteria. Potential participants may join from Texas Oncology-Tyler in Tyler, as well as Virginia's Texas Oncology-Quebec."

Answered by AI

To what medical purpose is Sotorasib typically prescribed?

"Sotorasib is typically prescribed to manage melanoma, but can also assist patients with macrocytic anemia, prior systemic therapy and malignant skin melanomas."

Answered by AI
~408 spots leftby Sep 2026