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Protocol # 20-200

Status

Recruiting

Description

This is a Phase 1 study of JSI-1187 as monotherapy and in combination with dabrafenib for the treatment of advanced solid tumors with MAPK pathway mutations, including mutations that cause MAPK pathway hyperactivation.

Condition

  • Solid Tumors

Interventions

  • JSI-1187
  • Dabrafenib

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Incidence of treatment emergent adverse events (safety and tolerability)

Secondary Outcome:

  • Objective Response Rate
  • Duration of Response
  • Time to Response
  • Disease Control Rate
  • Progression-Free Survival
  • Overall Survival

Enrollment

124

Study Start Date

June 18, 2020

Eligibility

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

Sponsors

JS InnoPharm, LLC

Source

JS InnoPharm, LLC

Official title

A Phase 1 Study of ERK1/2 Inhibitor JSI-1187 Administered as Monotherapy and in Combination With Dabrafenib for the Treatment of Advanced Solid Tumors With MAPK Pathway Mutations

Clinicaltrials.gov Identifier

NCT04418167

     

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.