Vanderbilt Clinical Trials

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

Purpose

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

Conditions

Advanced Solid Tumors
Kirsten Rat Sarcoma (KRAS) pG12C Mutation

Eligibility

Eligible Ages: Between 18 Years and 100 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Men or women greater than or equal to 18 years old. - 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.

Exclusion Criteria

Primary brain tumor. - Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors. - Myocardial infarction within 6 months of study day 1. - Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Sotorasib + trametinib + panitumumab	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.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: Trametinib Trametinib administered orally as a tablet. Drug: Panitumumab Panitumumab administered as an IV infusion.
Experimental Sotorasib + RMC-4630	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.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: RMC-4630 RMC-4630 administered orally as a capsule.
Experimental Sotorasib + afatinib	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.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: Afatinib afatinib administered orally as a tablet.
Experimental Sotorasib + panitumumab +/- chemotherapy	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.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: Panitumumab Panitumumab administered as an IV infusion. Drug: IV Chemotherapy (Regimen 1) 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.
Experimental Sotorasib + atezolizumab	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.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: Atezolizumab Atezolizumab administered as an IV injection.
Experimental Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab	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.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: Pembrolizumab pembrolizumab administered as an intravenous (IV) infusion. Drug: Carboplatin, pemetrexed, docetaxel, paclitaxel Carboplatin, pemetrexed, docetaxel administered as an IV infusion.
Experimental Sotorasib Monotherapy	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.	Drug: Sotorasib Sotorasib administered orally as a tablet.
Experimental Sotorasib + palbociclib	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.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: Palbociclib Palbociclib administered orally as a tablet.
Experimental Sotorasib + pembrolizumab	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.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: Pembrolizumab pembrolizumab administered as an intravenous (IV) infusion.
Experimental Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy	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.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: MVASI® (bevacizumab-awwb) MVASI® (bevacizumab-awwb) administered as an IV infusion. Drug: IV Chemotherapy (Regimen 1) 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. Drug: IV Chemotherapy (Regimen 2) 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.
Experimental Sotorasib + TNO155	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.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: TNO155 TNO155 administered orally as a capsule.
Experimental Sotorasib + BI 1701963	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.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: BI 1701963 BI 1701963 administered orally
Experimental Sotorasib + AMG 404	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	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: AMG 404 AMG 404 administered as an IV infusion.
Experimental Sotorasib + everolimus	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.	Drug: Sotorasib Sotorasib administered orally as a tablet. Drug: Everolimus Everolimus administered orally.

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

More Details

Status: Recruiting
Sponsor: Amgen

Study Contact

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

Notice

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