Description:
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
Title
- Brief Title: A Study of MPT-0118 in Subjects With Advanced or Metastatic Refractory Solid Tumors
- 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
Clinical Trial IDs
- ORG STUDY ID:
MPT-0118-101
- NCT ID:
NCT04859777
Conditions
- Solid Tumor, Adult
- Advanced Solid Tumor
- Advanced Cancer
- Metastatic Cancer
- Refractory Cancer
Interventions
Drug | Synonyms | Arms |
---|
MPT-0118 | | Part A: |
MPT-0118 + pembrolizumab | | Part B: |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Part A: | Experimental | Dose-escalation oral MPT-0118 BID | |
Part B: | Experimental | Dose-escalation oral MPT-0118 BID + pembrolizumab (IV) | |
Part C: | Experimental | Dose-expansion oral MPT-0118 BID + pembrolizumab (IV) | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Part A: To determine the MTD or the RP2D of MPT-0118 |
Time Frame: | 1 cycle / 28 days |
Safety Issue: | |
Description: | 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. |
Secondary Outcome Measures
Measure: | Part A and B: Maximum plasma concentration of MPT-0118 |
Time Frame: | 1 cycle / 28 days |
Safety Issue: | |
Description: | |
Measure: | Part A and B: ORR based on RECIST v 1.1 and iRECIST |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | |
Measure: | Part A and B: DoR based on RECIST v 1.1 and iRECIST |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | |
Measure: | Part A and B: PFS based on RECIST v 1.1 and iRECIST |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | |
Measure: | Part C: Assessment of Overall Survival |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Monopteros Therapeutics Inc. |
Trial Keywords
Last Updated
August 6, 2021