NCT04185883

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

A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 610 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Interventions

Type	Name	Description
DRUG	Sotorasib	Sotorasib administered orally as a tablet.
DRUG	Trametinib	Trametinib administered orally as a tablet.
DRUG	RMC-4630	RMC-4630 administered orally as a capsule.
DRUG	Afatinib	afatinib administered orally as a tablet.
DRUG	Pembrolizumab	pembrolizumab administered as an intravenous (IV) infusion.
DRUG	Panitumumab	Panitumumab administered as an IV infusion.
DRUG	Carboplatin, pemetrexed, docetaxel, paclitaxel	Carboplatin, pemetrexed, docetaxel administered as an IV infusion.
DRUG	Atezolizumab	Atezolizumab administered as an IV injection.
DRUG	Palbociclib	Palbociclib administered orally as a tablet.
DRUG	MVASI® (bevacizumab-awwb)	MVASI® (bevacizumab-awwb) administered as an IV infusion.
DRUG	TNO155	TNO155 administered orally as a capsule.
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.
DRUG	BI 1701963	BI 1701963 administered orally
DRUG	AMG 404	AMG 404 administered as an IV infusion.
DRUG	Everolimus	Everolimus administered orally.

Timeline

• Start date: 2019-12-17
• Primary completion: 2026-12-17
• Completion: 2027-12-05
• First posted: 2019-12-04
• Last updated: 2025-10-22

Locations

90 sites across 13 countries: United States, Australia, Austria, Belgium, Canada, Germany, Italy, Japan, Netherlands, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study