Search Cancer Clinical Trials

The Cancer Center offers patients access to a wide variety of clinical trials of promising new therapies. Use the search tool to find open protocols for your type of cancer.
Search by condition
Search By:
Protocol # 21-332

Status

Recruiting

Description

This is a Phase 1/1b open-label, dose-escalation, and cohort expansion study with BID (tablet) oral dose of MPT-0118 in subjects with advanced or metastatic refractory solid tumors. The study will be conducted in 3 parts: - Part A: MPT-0118 dose-escalation - Part B: MPT-0118 dose-escalation in combination with pembrolizumab - Part C: Cohort expansion of MPT-0118 in combination with pembrolizumab

Condition

  • Solid Tumor, Adult
  • Advanced Solid Tumor
  • Advanced Cancer
  • Metastatic Cancer
  • Refractory Cancer

Interventions

  • MPT-0118
  • MPT-0118 + pembrolizumab

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Part A: To determine the MTD or the RP2D of MPT-0118
  • Part B: To determine the MTD or the RP2D of MPT-0118 + pembrolizumab
  • Part C: Number of subjects with TEAEs as assessed by NCI-CTCAE v5.0
  • Part C: Objective response rate (ORR) based on RECIST v1.1 and iRECIST
  • Part C: Duration of response (DoR) based on RECIST v1.1 and iRECIST
  • Part C: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST

Secondary Outcome:

  • Part A and B: Maximum plasma concentration of MPT-0118
  • Part A and B: ORR based on RECIST v 1.1 and iRECIST
  • Part A and B: DoR based on RECIST v 1.1 and iRECIST
  • Part A and B: PFS based on RECIST v 1.1 and iRECIST
  • Part C: Assessment of Overall Survival

Enrollment

70

Study Start Date

April 13, 2021

Eligibility

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

Sponsors

Monopteros Therapeutics Inc.

Source

Monopteros Therapeutics Inc.

Official title

A Phase 1/1b Study of MPT-0118 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Refractory Solid Tumors

Clinicaltrials.gov Identifier

NCT04859777

     

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.