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

September 15, 2021 updated by: 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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Recruiting
        • St. John's Cancer Center
        • Principal Investigator:
          • Przemyslaw W. Twardowski, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Principal Investigator:
          • Emerson A Lim, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Aung Naing, MD, FACP
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • NEXT Oncology
        • Principal Investigator:
          • David Sommerhalder, MD
        • Contact:
          • Cynthia DeLeon
          • Phone Number: 210-580-9521

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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)

Key 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
  11. Has active hepatitis B or C infection
  12. Women who are pregnant or breastfeeding
  13. Has an unwillingness or inability to comply with procedures required in this protocol
  14. Is currently receiving any other anticancer or investigational agent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A:
Dose-escalation oral MPT-0118 BID
Drug: MPT-0118
MPT-0118 is an inhibitor of MALT1 protease
Experimental: Part B:
Dose-escalation oral MPT-0118 BID + pembrolizumab (IV)
Drug: MPT-0118 + pembrolizumab
MPT-0118 is an inhibitor of MALT1 protease; pembrolizumab is a PD-1 inhibitor
Experimental: Part C:
Dose-expansion oral MPT-0118 BID + pembrolizumab (IV)
Drug: MPT-0118 + pembrolizumab
MPT-0118 is an inhibitor of MALT1 protease; pembrolizumab is a PD-1 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: To determine the MTD or the RP2D of MPT-0118
Time Frame: 1 cycle / 28 days
The incidence and severity of treatment-emergent adverse events (TEAEs) qualifying as protocol-defined DLTs in Cycle 1 will guide the establishment of the protocol-defined RP2D and/or MTD.
1 cycle / 28 days
Part B: To determine the MTD or the RP2D of MPT-0118 + pembrolizumab
Time Frame: 1 cycle / 28 days
The incidence and severity of TEAEs qualifying as protocol-defined DLTs in Cycle 1 will guide the establishment of the protocol-defined RP2D and/or MTD.
1 cycle / 28 days
Part C: Number of subjects with TEAEs as assessed by NCI-CTCAE v5.0
Time Frame: Through study completion, an average of 1 year
Incidence of TEAEs will be used to assess the safety of MPT-0118 + pembrolizumab
Through study completion, an average of 1 year
Part C: Objective response rate (ORR) based on RECIST v1.1 and iRECIST
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Part C: Duration of response (DoR) based on RECIST v1.1 and iRECIST
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Part C: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Part A and B: Maximum plasma concentration of MPT-0118
Time Frame: 1 cycle / 28 days
1 cycle / 28 days
Part A and B: ORR based on RECIST v 1.1 and iRECIST
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Part A and B: DoR based on RECIST v 1.1 and iRECIST
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Part A and B: PFS based on RECIST v 1.1 and iRECIST
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year
Part C: Assessment of Overall Survival
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monopteros Therapeutics Inc.

Investigators

  • Study Director: Arthur DeCillis, MD, Monopteros Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2021

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 26, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPT-0118-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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