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Molecular Glue Degrader
MRT-2359 for Solid Tumors
Phase 1 & 2
Recruiting
Research Sponsored by Monte Rosa Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a selected advanced solid tumor or DLBCL for which there are no further standard therapeutic options available
Be age ≥ 18 years and willing to voluntarily complete the informed consent process
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new drug to treat selected solid tumors. The goal is to find the maximum tolerated dose and/or recommended Phase 2 dose of the drug.
Who is the study for?
Adults over 18 with certain advanced cancers (like lung cancer, neuroendocrine carcinoma, or lymphoma) who've tried other treatments without success. They must be expected to live at least 3 months, be able to perform daily activities with minimal assistance, and use birth control. People can't join if they've had recent cancer treatments that haven't worn off yet or have serious health issues like active infections or heart disease.Check my eligibility
What is being tested?
The trial is testing MRT-2359 pills on patients with specific cancers. It's in two parts: first finding the highest dose people can take without bad side effects (Phase 1), then seeing how well it works at that dose (Phase 2). The focus is also on genetic markers related to the cancer.See study design
What are the potential side effects?
Possible side effects of MRT-2359 aren't listed but generally may include typical reactions such as nausea, fatigue, and risk of infection due to immune system impact. Specific risks will become clearer as the trial progresses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My advanced cancer has no more standard treatment options.
Select...
I am 18 years or older and agree to the informed consent process.
Select...
I am expected to live more than 3 months and can care for myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Phase 2 Evaluates preliminary anti-tumor activity of MRT-2359 by overall response rate (ORR) as determined by RECIST 1.1
Secondary outcome measures
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
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
Disease
+8 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Phase 2 Expansion - SCLCExperimental Treatment1 Intervention
Patients with SCLC
Group II: Phase 2 Expansion - Prostate CancerExperimental Treatment1 Intervention
Patients with prostate cancer in combination with enzalutamide
Group III: Phase 2 Expansion - NSCLCExperimental Treatment1 Intervention
Patients with NSCLC with high or low L-MYC or N-MYC expression
Group IV: Phase 2 Expansion - L-MYC or N-MYC amplified solid tumorsExperimental Treatment1 Intervention
Patients with L-MYC or N-MYC amplified solid tumors
Group V: Phase 2 Expansion - HR-positive, HER2-negative breast cancerExperimental Treatment1 Intervention
Patients with HR-positive, HER2-negative breast cancer in combination with fulvestrant
Group VI: Phase 1 Dose EscalationExperimental Treatment1 Intervention
Patients with NSCLC, SCLC, high-grade neuroendocrine cancer of any primary site, any solid tumors with L-MYC or N-MYC amplification, or DLBCL
Find a Location
Who is running the clinical trial?
Monte Rosa Therapeutics, IncLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had pneumonitis treated with steroids.I have not had a live vaccine in the last 90 days.I had a stem cell transplant before and haven't fully recovered.I have hepatitis B or C but it's under control.I am not on high doses of steroids; 10 mg/day of prednisone or less is okay.My brain metastases are stable and I don't need steroids.I have HIV but am on treatment and my viral load is undetectable.I have a serious heart condition.My advanced cancer has no more standard treatment options.I have taken bisphosphonates or denosumab in the last 14 days, not for acute hypercalcemia.I had a stem cell transplant within the last 6 months or have symptoms of graft-versus-host disease.I am 18 years or older and agree to the informed consent process.I am expected to live more than 3 months and can care for myself.You have a specific amount of detectable disease according to specific medical guidelines for tumors or lymphoma.I am a man who can father a child and will use birth control until 90 days after the study ends.I haven't had cancer treatment or been in a trial within the last 3 weeks, and any side effects from past treatments have gone away.I have a condition that affects how my body absorbs medication.I cannot swallow pills.I received a COVID-19 vaccine within 14 days before starting MRT-2359.I stopped a GSPT1 degrader treatment because of side effects.I had another type of cancer but it's under control without needing treatment.My organs are functioning well according to recent tests.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Dose Escalation
- Group 2: Phase 2 Expansion - Prostate Cancer
- Group 3: Phase 2 Expansion - SCLC
- Group 4: Phase 2 Expansion - L-MYC or N-MYC amplified solid tumors
- Group 5: Phase 2 Expansion - HR-positive, HER2-negative breast cancer
- Group 6: Phase 2 Expansion - NSCLC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many venues is this research effort implemented across?
"Patients that meet the eligibility criteria can be enrolled in this medical trial at Sarah Cannon Research Institute based in Nashville, TN; South Texas Accelerated Research Therapeutics (START) situated in San Antonio; New york's Memorial Sloan Kettering Cancer Center and 8 other venues."
Answered by AI
What is the cap on participation in this research endeavor?
"To proceed with this investigation, 133 prospective participants that meet the requirements need to be recruited. Sarah Cannon Research Institute in Nashville and START in San Antonio are two of many sites offering enrollment opportunities."
Answered by AI
Are there any vacancies remaining in this trial for participants?
"Affirmative, the evidence on clinicaltrials.gov shows that this medical experiment is still seeking volunteers. The trial was originally placed online in October 27th 2022 and has been modified as recently as November 9th 2022. At present, there are 8 sites recruiting a combined 133 patients for this study."
Answered by AI
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