Search Cancer Clinical Trials
Recruiting
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
- Solid Tumor, Adult
- Advanced Solid Tumor
- Advanced Cancer
- Metastatic Cancer
- Refractory Cancer
- MPT-0118
- MPT-0118 + pembrolizumab
Phase 1
Interventional
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
70
April 13, 2021
- Gender: All
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
Monopteros Therapeutics Inc.
Monopteros Therapeutics Inc.
A Phase 1/1b Study of MPT-0118 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Refractory Solid Tumors
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.