Adagrasib in Combination With Nab-Sirolimus in Patients Wtih Advanced Solid Tumors and Non-Small Cell Lung Cancer Wtih a KRAS G12C Mutation (KRYSTAL -19)

• Status: Not yet recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mirati Therapeutics Inc.
• Collaborator: Aadi Bioscience, Inc.
• Treatments: Adagrasib; Sirolimus

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of solid tumor malignancy (Phase 1) or NSCLC (Phase 2) with KRAS G12C mutation

• Unresectable or metastatic disease

• No available treatment with curative intent

• Adequate organ function

• Measurable disease per RECIST 1.1.

Exclusion Criteria:

• History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow

• History of interstitial lung disease or radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease or pneumonitis

• Cardiac abnormalities