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)

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Mirati Therapeutics Inc.
Study ID
NCT05840510
Phase
PHASE1
Status
Terminated

Conditions

  • Advanced Cancer
  • Malignant Neoplastic Disease
  • Metastatic Cancer
  • NSCLC
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adagrasib — DRUG
    KRAS G12C inhibitor
  • nab-Sirolimus — DRUG
    mTOR inhibitor

Study Details

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.

Key Dates

Start date
Aug 7, 2023
Status verified
Apr 2025
Primary completion
Dec 27, 2024
Completion
Dec 27, 2024

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation and Clinical Efficacy
    Dose escalation of adagrasib and nab-Sirolimus to determine maximum tolerated dose in combination and evaluate the clinical efficacy of adagrasib in combination with nab-sirolimus in patients with solid tumors (Phase 1) and NSCLC (Phase 2) harboring a KRAS G12C mutation

Primary Outcome Measure

Phase 1: Safety and tolerability in the study population. [ Time Frame: 30 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Local Institution - 019-104ClevelandOhio44121-
Local Institution - 019-101NashvilleTennessee37203-
Local Institution - 019-102HoustonTexas77030-4000-

Find similar trials in Cleveland, OH

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Local Institution - 019-104· Cleveland, OHLocal Institution - 019-101· Nashville, TNLocal Institution - 019-102· Houston, TX

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