- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05546268
Study of Oral MRT-2359 in Selected Cancer Patients
A Phase 1/2 Study of Oral MRT-2359 in Patients With MYC-Driven and Other Selected Solid Tumors Including Lung Cancer and Diffuse B-Cell Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This Phase 1/2, open-label, multicenter, dose escalation and expansion study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary clinical activity of MRT-2359 in patients with previously treated selected solid tumors, including lung cancer (NSCLC and SCLC), high-grade neuroendocrine cancer of any primary site, and DLBCL.
- The primary aim of Phase 1 part is safety, tolerability, MTD and/or RP2D of MRT-2359.
- The primary aim of Phase 2 part is assessment of preliminary anti-tumor activity of MRT-2359.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Monte Rosa Therapeutics
- Phone Number: 617-865-4792
- Email: Clinicaltrials@monterosatx.com
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Not yet recruiting
- Cross Cancer Institute
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Not yet recruiting
- Princess Margaret Hospital
-
-
-
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Arizona
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Scottsdale, Arizona, United States, 85258
- Recruiting
- Honor Health Research Institute
-
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California
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San Diego, California, United States, 92037
- Not yet recruiting
- University of California San Diego
-
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Connecticut
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New Haven, Connecticut, United States, 06520
- Not yet recruiting
- Yale University
-
-
Florida
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Lake Mary, Florida, United States, 32746
- Recruiting
- Sarah Cannon Research Institute
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Indiana
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Bloomington, Indiana, United States, 46202
- Recruiting
- Indiana University
-
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Kansas
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Lawrence, Kansas, United States, 66044
- Not yet recruiting
- University of Kansas Cancer Center
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Dana Farber Cancer Institute
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Michigan
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Detroit, Michigan, United States, 48202
- Not yet recruiting
- Henry Ford Cancer Institute
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Missouri
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Saint Louis, Missouri, United States, 63110
- Not yet recruiting
- Washington University
-
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New York
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New York, New York, United States, 10021
- Recruiting
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10032
- Recruiting
- Columbia University Irving Medical Centre
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Tennessee
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Nashville, Tennessee, United States, 37203
- Recruiting
- Sarah Cannon Research Institute
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Texas
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Dallas, Texas, United States, 75251
- Recruiting
- Mary Crowley Cancer Research
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Houston, Texas, United States, 77030-4009
- Recruiting
- MD Anderson Cancer Center
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San Antonio, Texas, United States, 78229
- Recruiting
- South Texas Accelerated Research Therapeutics (START)
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Virginia
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Fairfax, Virginia, United States, 22031
- Not yet recruiting
- Virginia Cancer Specialists Research Institute
-
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Washington
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Seattle, Washington, United States, 98109
- Recruiting
- Fred Hutchinson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Phase 1 enrollment population:
- NSCLC
- SCLC
- High-grade neuroendocrine cancer of any primary site
- Any solid tumors with L-MYC or N-MYC amplification
- DLBCL
Phase 2 enrollment population:
- Any solid tumors with L-MYC or N-MYC amplification
- NSCLC with high or low L-MYC or N-MYC expression status (testing will be provided) or SCLC
Phase 1 and Phase 2 Inclusion Criteria:
- Have a selected advanced solid tumor or DLBCL (listed above) for which there are no further standard therapeutic options available
- Be age ≥ 18 years and willing to voluntarily complete the informed consent process
- A predicted life expectancy of ≥ 3 months and an ECOG performance status ≤ 2
- Have measurable disease by RECIST 1.1 (Eisenhauer et al., 2009) in case of solid tumors or Revised Response Criteria for Malignant Lymphoma (Phase 1 only) (Cheson et al., 2014) in case of DLBCL
- Have adequate organ function defined by the selected laboratory parameters
- If female of childbearing potential, avoid becoming pregnant and agree to use acceptable methods of contraception after informed consent, throughout the study, and for 90 days after the last dose of MRT-2359
- Male of reproductive potential must use an approved methods of contraception from informed consent until 90 days after study discharge
Exclusion Criteria:
- Have received prior chemotherapy, definitive radiation, biological cancer therapy or any investigational agent within 21 days before the first dose of study treatment, or have any AEs that have failed to recover to baseline. In patients with prostate cancer, continuance of systemic therapies to maintain castration levels of testosterone is allowed. Pre-menopausal patients with hormone-dependent breast cancer can continue on therapies used for suppression of ovarian function.
- Have received bisphosphonates or denosumab within 14 days before the first administration of the study drug unless they were given for acute hypercalcemia
- Inability to swallow oral medication
- Have received prior therapy with a GSPT1 degrader that was discontinued due to an AE
- Have received prior auto-HCT and not fully recovered from effects of the last transplant
- Have received prior allogeneic hematopoietic stem cell transplantation within past 6 months and/or have symptoms of graft-versus-host disease. Patients requiring minimal intervention such as topical steroids are eligible
- Have received a live vaccine within 90 days before the first dose of study treatment
- COVID-19 immunization within 14 days of receiving the first dose of MRT-2359
- Current use of chronic systemic steroid therapy in excess of replacement doses (prednisone ≤ 10 mg/day is acceptable)
- Have clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug
- Have a history of a second malignancy, unless controlled not requiring therapy
- Have clinically active central nervous system involvement and/or carcinomatous meningitis. Patients with treated and stable brain metastases (not progressing for at least 4 weeks prior to enrollment) not requiring steroids are eligible
- Have a confirmed history of (non-infectious) pneumonitis that required steroids
- Have known human immunodeficiency virus (HIV) unless the patient is on antiviral therapy with undetectable HIV RNA levels
- Have known hepatitis B or C infection(s) unless treated with undetectable hepatitis B DNA or hepatitis C RNA levels
- Clinically significant cardiac disease
- Be pregnant or breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase 1 Dose Escalation
Patients with NSCLC, SCLC, high-grade neuroendocrine cancer of any primary site, any solid tumors with L-MYC or N-MYC amplification, or DLBCL
|
Orally administered tablets of MRT-2359.
|
Experimental: Phase 2 Expansion - L-MYC or N-MYC amplified solid tumors
Patients with L-MYC or N-MYC amplified solid tumors
|
Orally administered tablets of MRT-2359.
|
Experimental: Phase 2 Expansion - NSCLC
Patients with NSCLC with high or low L-MYC or N-MYC expression
|
Orally administered tablets of MRT-2359.
|
Experimental: Phase 2 Expansion - SCLC
Patients with SCLC
|
Orally administered tablets of MRT-2359.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Phase 1 Evaluates safety and tolerability of MRT-2359 over a 28-day cycle by the occurrence and frequency of dose limiting toxicities (DLTs) for determination of the MTD and/or RP2D
Time Frame: 28 days
|
28 days
|
Phase 2 Evaluates preliminary anti-tumor activity of MRT-2359 by overall response rate (ORR) as determined by RECIST 1.1
Time Frame: 56 days (up to approximately 24 months from screening to end of study participation
|
56 days (up to approximately 24 months from screening to end of study participation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Phase 1 safety and tolerability of MRT-2359 (orally over a 28-day cycle) by the nature, incidence, and severity of all treatment-emergent adverse events (TEAEs), including treatment-related TEAEs and serious adverse events (SAEs)
Time Frame: 18 months
|
18 months
|
Phase 1 preliminary anti-tumor activity: ORR (RECIST 1.1/Revised Response Criteria for Malignant Lymphoma),duration of response for complete response(CR)/partial response(PR), disease control rate, progression-free survival, overall survival
Time Frame: 18 months
|
18 months
|
Phase 1 Dose Escalation characterizes the PK profile of MRT-2359 by standard primary PK parameters including, but not limited to, AUC, Cmax, tmax, and t1/2
Time Frame: 28 days
|
28 days
|
Phase 1 Dose Escalation evaluates the effect of a high-fat meal on the relative bioavailability of MRT-2359 by standard primary PK parameters including, but not limited to, AUC and Cmax
Time Frame: 7 days
|
7 days
|
Phase 2 Dose Expansion evaluates the safety and tolerability of MRT-2359 administered orally over a 28-day cycle by the nature, incidence, and severity of all TEAEs, including treatment-related TEAEs and SAEs according to the NCI CTCAE, version 5.0
Time Frame: 24 months
|
24 months
|
Phase 2 Dose Expansion evaluates additional measures of the preliminary anti-tumor activity of MRT-2359 such as DoR (in patients with the best overall response of CR or PR), DCR, PFS, and OS
Time Frame: 24 months
|
24 months
|
Phase 2 Dose Expansion further characterizes the PK profile of MRT-2359 by evaluating MRT-2359 plasma concentration to establish PK parameters including, but not limited to, Cmax, tmax, AUC0-t, AUC0-inf, mean residence time, accumulation ratio, etc.
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRT-2359-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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