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Protocol # 19-812

Status

Recruiting

Description

A phase 1, first-in-human, open-label study to determine the safety, tolerability, PK, and preliminary efficacy of the novel MET/CSF1R/SRC inhibitor TPX-0022 in adult subjects with advanced solid tumors harboring genetic alterations in MET. The study will proceed in three parts: a dose-escalation, a food effect, and dose-expansion.

Condition

  • Advanced Solid Tumor
  • Metastatic Solid Tumors
  • MET Gene Alterations

Interventions

  • TPX-0022

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0022
  • Define the Recommended Phase 2 Dose

Secondary Outcome:

  • Adverse events (AEs)
  • Cmax (maximum plasma concentration) of TPX-0022
  • AUC (area under plasma concentration time curve) of TPX-0022
  • Cmax (maximum plasma concentration) of TPX-0022 under different food intake conditions
  • AUC (area under plasma concentration time curve) of TPX-0022 under different food intake conditions
  • Preliminary Objective Response Rate (ORR)
  • Clinical benefit rate (CBR)
  • Time to response (TTR)
  • Duration of Response (DOR)
  • Progression free survival (PFS)
  • Intracranial tumor response
  • Overall survival (OS)

Enrollment

120

Study Start Date

August 20, 2019

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Turning Point Therapeutics, Inc.

Source

Turning Point Therapeutics, Inc.

Official title

A Phase 1, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0022, a Novel MET/CSF1R/SRC Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in MET

Clinicaltrials.gov Identifier

NCT03993873

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.