Solid Tumor, AdultPhase 1NCT04859777
A Study of MPT-0118 in Subjects With Advanced or Metastatic Refractory Solid Tumors
A Phase 1 study testing MPT-0118 and MPT-0118 + pembrolizumab in people with Solid Tumor, Adult and Advanced Solid Tumor, run by Monopteros Therapeutics Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Advanced Solid Tumor, Advanced Cancer
- What is being tested?
- MPT-0118 and MPT-0118 + pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Apr 2021to Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Is aged ≥18 years at the time of signing the ICF
- Has provided written informed consent
- Has an ECOG Performance Status of 0 or 1
- Has measurable disease per RECIST 1.1
- Has an adequate tumor sample.
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- Has adequate liver, renal, hematologic, pulmonary, cardiac, and coagulation function.
- 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
- 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)
Who cannot join
- Has received cytotoxic chemotherapy, biologic agent, investigational agent, checkpoint inhibitors, or radiation therapy ≤3 weeks prior to the first dose of MPT-0118
- Has received small-molecule kinase inhibitors or hormonal agents ≤14 days prior to the first dose of MPT-0118
- Has been previously treated with a MALT1 inhibitor
- 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
- Has received systemic immunosuppressive agents within 14 days of the first dose of MPT-0118
- Has undergone major surgery ≤6 weeks or minor surgery ≤14 days prior to the first dose of MPT-0118
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- Has clinically significant intercurrent disease
- 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
- Has primary central nervous system (CNS) tumors or brain or leptomeningeal metastasis.
- Has human immunodeficiency virus (HIV) infection
- Has active hepatitis B or C infection
- Women who are pregnant or breastfeeding
- Has an unwillingness or inability to comply with procedures required in this protocol
- Is currently receiving any other anticancer or investigational agent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jong Chul Park, MD
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
713-563-3885, anaing@mdanderson.org
Aung Naing, MD, FACP
- Recruiting
Columbia University
New York, New York, 10032
Emerson A Lim, MD
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
Cynthia DeLeon, 210-580-9521
David Sommerhalder, MD
- Recruiting
St. John's Cancer Center
Santa Monica, California, 90404
Przemyslaw W. Twardowski, MD
About this study
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
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
Read the 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
- Being tested
- MPT-0118, MPT-0118 + pembrolizumab
- Keywords
- MALT1 inhibitor
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPT-0118Drug
MPT-0118 is an inhibitor of MALT1 protease
MPT-0118 + pembrolizumabDrug
MPT-0118 is an inhibitor of MALT1 protease; pembrolizumab is a PD-1 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Part A: | Experimental | Dose-escalation oral MPT-0118 BID Receives: Drug: MPT-0118 |
| Part B: | Experimental | Dose-escalation oral MPT-0118 BID + pembrolizumab (IV) Receives: Drug: MPT-0118 + pembrolizumab |
| Part C: | Experimental | Dose-expansion oral MPT-0118 BID + pembrolizumab (IV) Receives: Drug: MPT-0118 + pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: To determine the MTD or the RP2D of MPT-0118
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.
Measured: 1 cycle / 28 days
Part B: To determine the MTD or the RP2D of MPT-0118 + pembrolizumab
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.
Measured: 1 cycle / 28 days
Part C: Number of subjects with TEAEs as assessed by NCI-CTCAE v5.0
Incidence of TEAEs will be used to assess the safety of MPT-0118 + pembrolizumab
Measured: Through study completion, an average of 1 year
Part C: Objective response rate (ORR) based on RECIST v1.1 and iRECIST
Measured: Through study completion, an average of 1 year
Part C: Duration of response (DoR) based on RECIST v1.1 and iRECIST
Measured: Through study completion, an average of 1 year
Part C: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST
Measured: Through study completion, an average of 1 year
Secondary outcomes (5)
Part A and B: Maximum plasma concentration of MPT-0118
Measured: 1 cycle / 28 days
Part A and B: ORR based on RECIST v 1.1 and iRECIST
Measured: Through study completion, an average of 1 year
Part A and B: DoR based on RECIST v 1.1 and iRECIST
Measured: Through study completion, an average of 1 year
Part A and B: PFS based on RECIST v 1.1 and iRECIST
Measured: Through study completion, an average of 1 year
Part C: Assessment of Overall Survival
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start13 Apr 2021
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monopteros Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur DeCillis, MD, Study director, Monopteros Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859777
- Sponsor's protocol ID
- MPT-0118-101
- Status last verified
- Aug 2021
- First submitted
- 19 Apr 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Di Pilato M, Gao Y, Sun Y, Fu A, Grass C, Seeholzer T, Feederle R, Mazo I, Kazer SW, Litchfield K, von Andrian UH, Mempel TR, Jenkins RW, Krappmann D, Keller P. Translational Studies Using the MALT1 Inhibitor (S)-Mepazine to Induce Treg Fragility and Potentiate Immune Checkpoint Therapy in Cancer. J Immunother Precis Oncol. 2023 Mar 3;6(2):61-73. doi: 10.36401/JIPO-22-18. eCollection 2023 May.
PubMed 37214210
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04859777
- Acronym / sponsor ID
- MPT-0118-101
- Conditions
- Solid Tumor, Adult, Advanced Solid Tumor, Advanced Cancer, Metastatic Cancer, Refractory Cancer
- Keywords
- MALT1 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Monopteros Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Part A: | Experimental | Drug: MPT-0118Dose-escalation oral MPT-0118 BID |
| Part B: | Experimental | Drug: MPT-0118 + pembrolizumabDose-escalation oral MPT-0118 BID + pembrolizumab (IV) |
| Part C: | Experimental | Drug: MPT-0118 + pembrolizumabDose-expansion oral MPT-0118 BID + pembrolizumab (IV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Is aged ≥18 years at the time of signing the ICF
- Has provided written informed consent
- Has an ECOG Performance Status of 0 or 1
- Has measurable disease per RECIST 1.1
Key exclusion criteria (14 listed)
- Has received cytotoxic chemotherapy, biologic agent, investigational agent, checkpoint inhibitors, or radiation therapy ≤3 weeks prior to the first dose of MPT-0118
- Has received small-molecule kinase inhibitors or hormonal agents ≤14 days prior to the first dose of MPT-0118
- Has been previously treated with a MALT1 inhibitor
- 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
- Has received systemic immunosuppressive agents within 14 days of the first dose of MPT-0118
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPT-0118MPT-0118 is an inhibitor of MALT1 protease | Drug | Part A: |
| MPT-0118 + pembrolizumabMPT-0118 is an inhibitor of MALT1 protease; pembrolizumab is a PD-1 inhibitor | Drug | Part B:, Part C: |
Primary outcome
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.
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.
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
Part C: Objective response rate (ORR) based on RECIST v1.1 and iRECIST
Time frame: 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
Part C: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST
Time frame: Through study completion, an average of 1 year
5 secondary outcomes
Part A and B: Maximum plasma concentration of MPT-0118
Time frame: 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
Part A and B: DoR based on RECIST v 1.1 and iRECIST
Time frame: 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
Part C: Assessment of Overall Survival
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 37214210Di Pilato M, Gao Y, Sun Y, Fu A, Grass C, Seeholzer T, Feederle R, Mazo I, Kazer SW, Litchfield K, von Andrian UH, Mempel TR, Jenkins RW, Krappmann D, Keller P. Translational Studies Using the MALT1 Inhibitor (S)-Mepazine to Induce Treg Fragility and Potentiate Immune Checkpoint Therapy in Cancer. J Immunother Precis Oncol. 2023 Mar 3;6(2):61-73. doi: 10.36401/JIPO-22-18. eCollection 2023 May.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur DeCillis, MD study director
Monopteros Therapeutics Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MPT-0118 and MPT-0118 + pembrolizumab in people with Solid Tumor, Adult and Advanced Solid Tumor, run by Monopteros Therapeutics Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Keller (617-812-0118, ClinicalTrials@Monopterostx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: To determine the MTD or the RP2D of MPT-0118 (time frame: 1 cycle / 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04859777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.