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A Study of MPT-0118 in Subjects With Advanced or Metastatic Refractory Solid Tumors | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

NCT04859777•Monopteros Therapeutics Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Has a histologically- or cytologically-diagnosed solid tumor which is advanced or metastatic and which has progressed on or following at least one systemic therapy regimen administered for advanced or metastatic disease or for which no approved therapy exists. Subject's prior treatment should include all approved regimens that have demonstrated a survival advantage for the subject's disease, stage, and line of therapy.
•2. Is aged ≥18 years at the time of signing the ICF
•3. Has provided written informed consent
•4. Has an ECOG Performance Status of 0 or 1
•5. Has measurable disease per RECIST 1.1
•6. Has an adequate tumor sample.
•7. Has adequate liver, renal, hematologic, pulmonary, cardiac, and coagulation function.
•8. Has a negative serum pregnancy test (for women of child-bearing potential) at Screening and a negative urine pregnancy test on Day 1 prior to the first dose of MPT 0118
•9. Ability to swallow and retain and absorb oral medications in tablet or crushed form orally or via feeding tube (e.g., nasogastric feeding tube or percutaneous endoscopic gastrostomy feeding tube)

Exclusion Criteria

•1. Has received cytotoxic chemotherapy, biologic agent, investigational agent, checkpoint inhibitors, or radiation therapy ≤3 weeks prior to the first dose of MPT-0118
•2. Has received small-molecule kinase inhibitors or hormonal agents ≤14 days prior to the first dose of MPT-0118
•3. Has been previously treated with a MALT1 inhibitor
•4. Has clinically significant AEs that have not returned to baseline or ≤Grade 1 based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
•5. Has received systemic immunosuppressive agents within 14 days of the first dose of MPT-0118
•6. Has undergone major surgery ≤6 weeks or minor surgery ≤14 days prior to the first dose of MPT-0118
•7. Has clinically significant intercurrent disease
•8. Part B and Part C: Has previously been treated with PD-1, PD-L1, or CTLA-4 inhibitors and required dose-interruption, permanent discontinuation, or systemic immunosuppression due to immune-related AEs
•9. Has primary central nervous system (CNS) tumors or brain or leptomeningeal metastasis.
•10. Has human immunodeficiency virus (HIV) infection
+4 more criteria

Locations (5)

St. John's Cancer Center

Santa Monica, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Columbia University

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Key Dates

Start Date

April 13, 2021

Primary Completion Date

March 1, 2023

Completion Date

March 1, 2023

Last Updated

September 16, 2021

Enrollment

ESTIMATED participants

Conditions

Solid Tumor, AdultAdvanced Solid TumorAdvanced CancerMetastatic CancerRefractory Cancer

Interventions

MPT-0118

DRUG

MPT-0118 + pembrolizumab

DRUG

Contacts

Peter Keller

CONTACT

617-812-0118 ClinicalTrials@Monopterostx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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