What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as radiotherapy, androgen deprivation therapy (ADT), and chemotherapy, have a range of side effects. Radiotherapy can cause gastrointestinal (GI) and genitourinary (GU) toxicities, though severe toxicities are rare. ADT is associated with side effects like impaired growth, decreased bone density, sexual dysfunction, and vasomotor symptoms. Chemotherapy, including drugs like ketoconazole and cyclophosphamide, can lead to fatigue, nausea, and a significant reduction in PSA levels. Newer treatments like GSPT1 molecular glue degraders are still under investigation, but their side effects are being closely monitored to determine safety and tolerability.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer that target specific molecular pathways and genetic markers. Notable examples include androgen receptor signaling inhibitors like enzalutamide and abiraterone acetate, which are used in metastatic castration-resistant prostate cancer (mCRPC). Additionally, radioligand therapies such as lutetium Lu 177 vipivotide tetraxetan have been approved for PSMA-positive mCRPC. These treatments focus on disrupting cancer cell growth and survival pathways, similar to the approach of molecular glue degraders like MRT-2359.

What other types of research exist?

Promising novel alternatives to MRT-2359 for prostate cancer patients include: <ol> <li>[177Lu]Lu-PSMA: A radionuclide treatment showing high response rates and low toxicity in metastatic castration-resistant prostate cancer (mCRPC).</li> <li>[225Ac]Ac-PSMA: Another MRT agent demonstrating efficacy in clinical trials for mCRPC.</li> <li>[223Ra]Ra-dichloride: Used for treating bone metastases in prostate cancer.</li> <li>Platinum-based chemotherapy: Particularly effective in patients with DNA repair gene alterations.</li> <li></li> </ol> PSMA-targeted PET imaging agents like Ga-68 PSMA-11 and piflufolastat F-18: Useful for detecting recurrent prostate cancer and guiding treatment decisions.

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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

Must not have

Have received prior auto-HCT and not fully recovered from effects of the last transplant

Current use of chronic systemic steroid therapy in excess of replacement doses (prednisone ≤ 10 mg/day is acceptable)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called MRT-2359 that breaks down a protein in cancer cells. It targets patients with certain types of previously treated cancers. The drug aims to destroy a protein crucial for cancer cell survival, potentially stopping or slowing the cancer.

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.

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.

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 below

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My advanced cancer has no more standard treatment options.

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I am 18 years or older and agree to the informed consent process.

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I am expected to live more than 3 months and can care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stem cell transplant before and haven't fully recovered.

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I am not on high doses of steroids; 10 mg/day of prednisone or less is okay.

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I have a serious heart condition.

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I have had pneumonitis treated with steroids.

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I have a condition that affects how my body absorbs medication.

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I cannot swallow pills.

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I received a COVID-19 vaccine within 14 days before starting MRT-2359.

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I stopped a GSPT1 degrader treatment because of side effects.

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I had another type of cancer but it's under control without needing treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for prostate cancer include androgen deprivation therapy (ADT), which reduces androgen levels to slow cancer growth, and second-generation antiandrogens like enzalutamide and apalutamide, which inhibit androgen receptor signaling. Abiraterone works by blocking androgen production from all sources, including the adrenal glands and the tumor itself. Bone-modifying agents, such as zoledronic acid and denosumab, are used to prevent skeletal-related events in patients with bone metastases. These treatments are crucial as they target the hormonal pathways that prostate cancer cells rely on for growth and survival. In comparison, GSPT1 molecular glue degraders like MRT-2359 represent a novel approach by promoting the degradation of specific proteins essential for cancer cell survival, potentially offering a new therapeutic avenue for patients with advanced prostate cancer.

[Expert consensus on clinical diagnosis and treatment of bone metastases and bone-related diseases of prostate cancer (2021 edition)].[177Lu]-PSMA-617 radionuclide treatment in patients with metastatic castration-resistant prostate cancer (LuPSMA trial): a single-centre, single-arm, phase 2 study.