Phase 1Terminated
Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation (KRYSTAL -19)
A Phase 1/2 Trial of Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation
- Sponsor
- Mirati Therapeutics Inc. (Industry)
- Enrolment
- 6 enrolled
- Conditions
- Solid Tumor, Adult; NSCLC; Advanced Cancer; Metastatic Cancer; Malignant Neoplastic Disease
- Interventions
- Adagrasib; nab-Sirolimus
- Ages
- adults, older adults
- Registry
- NCT05840510
Full record on ClinicalTrials.gov
From the registry
This study will evaluate the safety, MTD and/or RP2D, PK, and clinical activity of the combination of adagrasib with nab-sirolimus in patients with advanced solid tumors/NSCLC with a KRAS G12C mutation.
Primary outcomes
- Phase 1: Safety and tolerability in the study population.
- Phase 1: Maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D)
- Phase 2: Objective Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) (Phase 2)
History
Last registry update
Primary completion
Started
Registered