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Protocol # 21-184

Status

Recruiting

Description

This is a Phase 1/2, multicenter, open label, first in human (FIH) study of DCC-3116 as monotherapy, and in combination with trametinib, binimetinib, or sotorasib in patients with advanced or metastatic solid tumors with RAS/MAPK pathway mutation. The study consists of 2 parts, a dose-escalation phase, and an expansion phase.

Condition

  • Pancreatic Ductal Adenocarcinoma
  • Non-Small Cell Lung Cancer
  • Colorectal Cancer
  • Melanoma
  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Interventions

  • DCC-3116
  • Trametinib
  • Binimetinib
  • Sotorasib

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Incidence of Adverse Events
  • Maximum tolerated dose (MTD)
  • Objective response rate (ORR) (Expansion Phase)

Secondary Outcome:

  • Duration of response (DoR) (Escalation Phase)
  • Disease Control Rate (DCR) (Escalation Phase)
  • Time to response (Escalation Phase)
  • Progression-free survival (PFS) (Escalation Phase)
  • Maximum observed concentration (Cmax)
  • Time to maximum observed concentration (Tmax)
  • Minimum observed concentration (Cmin)
  • Area under the concentration-time curve( AUC)

Enrollment

323

Study Start Date

June 15, 2021

Eligibility

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

Sponsors

Deciphera Pharmaceuticals LLC

Source

Deciphera Pharmaceuticals LLC

Official title

A Phase 1/2, First-in-Human Study of DCC-3116 as Monotherapy and in Combination With RAS/MAPK Pathway Inhibitors in Patients With Advanced or Metastatic Solid Tumors With RAS/MAPK Pathway Mutations

Clinicaltrials.gov Identifier

NCT04892017

     

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.