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Trial record 1 of 1 for:    04859777
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A Study of MPT-0118 in Subjects With Advanced or Metastatic Refractory Solid Tumors

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ClinicalTrials.gov Identifier: NCT04859777
Recruitment Status : Recruiting
First Posted : April 26, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Monopteros Therapeutics Inc.

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Advanced Solid Tumor Advanced Cancer Metastatic Cancer Refractory Cancer Drug: MPT-0118 Drug: MPT-0118 + pembrolizumab Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Part A: Each dose-escalation cohort will initially recruit single-subject cohorts until a subject has a Grade 2 or greater adverse event (AE) during the DLT period considered at least possibly related to MPT-0118, at which time 2 additional subjects will be enrolled in that cohort, and a 3 + 3 design will subsequently be utilized.

Part B: Each dose-escalation cohort will initially recruit 3 patients to receive MPT-0118 + pembrolizumab in a standard 3+3 design; the cohort will be expanded in the event of a DLT.

Part C: Once the RP2D has been established for MPT-0118 monotherapy and combination therapy with MPT-0118 + pembrolizumab, expansion cohorts will be enrolled to further evaluate combination therapy.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 13, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. Part C: Objective response rate (ORR) based on RECIST v1.1 and iRECIST [ Time Frame: Through study completion, an average of 1 year ]
  5. Part C: Duration of response (DoR) based on RECIST v1.1 and iRECIST [ Time Frame: Through study completion, an average of 1 year ]
  6. Part C: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST [ Time Frame: Through study completion, an average of 1 year ]

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04859777


Contacts
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Contact: Peter Keller 617-812-0118 ClinicalTrials@Monopterostx.com

Locations
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United States, California
St. John's Cancer Center Recruiting
Santa Monica, California, United States, 90404
Principal Investigator: Przemyslaw W. Twardowski, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Jong Chul Park, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Principal Investigator: Emerson A Lim, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact    713-563-3885    anaing@mdanderson.org   
Principal Investigator: Aung Naing, MD, FACP         
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Cynthia DeLeon    210-580-9521      
Principal Investigator: David Sommerhalder, MD         
Sponsors and Collaborators
Monopteros Therapeutics Inc.
Investigators
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Study Director: Arthur DeCillis, MD Monopteros Therapeutics Inc.
More Information
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Responsible Party: Monopteros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04859777    
Other Study ID Numbers: MPT-0118-101
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Monopteros Therapeutics Inc.:
MALT1 inhibitor
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents