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Contact Information:

Amgen Call Center 866-572-6436
medinfo@amgen.com


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Be Part of Research - Trial Details - Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Recruiting

Open to: ALL

Age: 18.0 - 100.0

Medical Conditions

Neoplasms
Sarcoma


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2019 Jun 2026

Publications

"Kuboki Y, Fakih M, Strickler J, Yaeger R, Masuishi T, Kim EJ, Bestvina CM, Kopetz S, Falchook GS, Langer C, Krauss J, Puri S, Cardona P, Chan E, Varrieur T, Mukundan L, Anderson A, Tran Q, Hong DS. Sotorasib with panitumumab in chemotherapy-refractory KRASG12C-mutated colorectal cancer: a phase 1b trial. Nat Med. 2024 Jan;30(1):265-270. doi: 10.1038/s41591-023-02717-6. Epub 2024 Jan 4."; "38177853"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Sotorasib administered orally as a tablet.

Intervention Arm Group : Sotorasib + AMG 404;Sotorasib + BI 1701963;Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy;Sotorasib + RMC-4630;Sotorasib + TNO155;Sotorasib + afatinib;Sotorasib + atezolizumab;Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab;Sotorasib + everolimus;Sotorasib + palbociclib;Sotorasib + panitumumab +/- chemotherapy;Sotorasib + pembrolizumab;Sotorasib + trametinib + panitumumab;Sotorasib Monotherapy;

Intervention Type : DRUG
Intervention Description : Trametinib administered orally as a tablet.

Intervention Arm Group : Sotorasib + trametinib + panitumumab;

Intervention Type : DRUG
Intervention Description : RMC-4630 administered orally as a capsule.

Intervention Arm Group : Sotorasib + RMC-4630;

Intervention Type : DRUG
Intervention Description : afatinib administered orally as a tablet.

Intervention Arm Group : Sotorasib + afatinib;

Intervention Type : DRUG
Intervention Description : pembrolizumab administered as an intravenous (IV) infusion.

Intervention Arm Group : Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab;Sotorasib + pembrolizumab;

Intervention Type : DRUG
Intervention Description : Panitumumab administered as an IV infusion.

Intervention Arm Group : Sotorasib + panitumumab +/- chemotherapy;Sotorasib + trametinib + panitumumab;

Intervention Type : DRUG
Intervention Description : Carboplatin, pemetrexed, docetaxel administered as an IV infusion.

Intervention Arm Group : Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab;

Intervention Type : DRUG
Intervention Description : Atezolizumab administered as an IV injection.

Intervention Arm Group : Sotorasib + atezolizumab;

Intervention Type : DRUG
Intervention Description : Palbociclib administered orally as a tablet.

Intervention Arm Group : Sotorasib + palbociclib;

Intervention Type : DRUG
Intervention Description : MVASI® (bevacizumab-awwb) administered as an IV infusion.

Intervention Arm Group : Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy;

Intervention Type : DRUG
Intervention Description : TNO155 administered orally as a capsule.

Intervention Arm Group : Sotorasib + TNO155;

Intervention Type : DRUG
Intervention Description : Chemotherapy combination of leucovorin administered as an IV injection, 5-fluorouracil (5-FU) administered as IV bolus injection or IV continuous infusion (depending on dose), and irinotecan administered as IV injection.

Intervention Arm Group : Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy;Sotorasib + panitumumab +/- chemotherapy;

Intervention Type : DRUG
Intervention Description : IV chemotherapy combination of leucovorin administered as an IV injection, 5-FU administered as IV bolus injection or IV continuous infusion (depending on dose), and oxaliplatin administered as IV injection.

Intervention Arm Group : Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy;

Intervention Type : DRUG
Intervention Description : BI 1701963 administered orally

Intervention Arm Group : Sotorasib + BI 1701963;

Intervention Type : DRUG
Intervention Description : AMG 404 administered as an IV infusion.

Intervention Arm Group : Sotorasib + AMG 404;

Intervention Type : DRUG
Intervention Description : Everolimus administered orally.

Intervention Arm Group : Sotorasib + everolimus;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Sarah Cannon Research Institute UK
    London
    W1G 6AD

Amgen Call Center 866-572-6436
medinfo@amgen.com



The study is sponsored by Amgen




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Read full details for Trial ID: NCT04185883
Last updated 26 March 2025

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