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

First listed
May 3, 2023
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

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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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