NCT04859777

A Study of MPT-0118 in Subjects With Advanced or Metastatic Refractory Solid Tumors

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Monopteros Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

MPT-0118 will be administered orally twice daily (BID). Pembrolizumab will be administered intravenously (IV) at a dose of 200 mg every 3 weeks.

Conditions

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

Interventions

Type	Name	Description
DRUG	MPT-0118	MPT-0118 is an inhibitor of MALT1 protease
DRUG	MPT-0118 + pembrolizumab	MPT-0118 is an inhibitor of MALT1 protease; pembrolizumab is a PD-1 inhibitor

Timeline

• Start date: 2021-04-13
• Primary completion: 2023-03-01
• Completion: 2023-03-01
• First posted: 2021-04-26
• Last updated: 2021-09-16

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study