MRT-2359 for Solid Tumors

Recruiting at 20 trial locations

Overseen By Monte Rosa Therapeutics

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Monte Rosa Therapeutics, Inc

Must be taking: Fulvestrant, Enzalutamide

Must not be taking: Bisphosphonates, Denosumab, Steroids, others

Disqualifiers: Malabsorption, CNS involvement, Cardiac disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as chemotherapy, radiation, or biological cancer therapy, at least 21 days before starting the study treatment. However, if you have prostate cancer, you can continue therapies to maintain low testosterone levels, and pre-menopausal women with hormone-dependent breast cancer can continue therapies for ovarian function suppression.

Eligibility Criteria

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.

Inclusion Criteria

My advanced cancer has no more standard treatment options.

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

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

Exclusion Criteria

I have had pneumonitis treated with steroids.

Be pregnant or breastfeeding

I have not had a live vaccine in the last 90 days.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Escalation

Participants receive escalating doses of MRT-2359 to determine safety, tolerability, and maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D)

8-12 weeks

Phase 2 Expansion

Participants are enrolled based on molecular biomarkers stratification or selection to assess preliminary anti-tumor activity of MRT-2359

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• MRT-2359 (Molecular Glue Degrader)

Trial Overview 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.

Participant Groups

Group I: Phase 2 Expansion - SCLC Experimental Treatment 1 Intervention

Patients with SCLC

Group II: Phase 2 Expansion - Prostate Cancer Experimental Treatment 1 Intervention

Patients with prostate cancer in combination with enzalutamide

Group III: Phase 2 Expansion - NSCLC Experimental Treatment 1 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 tumors Experimental Treatment 1 Intervention

Patients with L-MYC or N-MYC amplified solid tumors

Group V: Phase 2 Expansion - HR-positive, HER2-negative breast cancer Experimental Treatment 1 Intervention

Patients with HR-positive, HER2-negative breast cancer in combination with fulvestrant

Group VI: Phase 1 Dose Escalation Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Monte Rosa Therapeutics, Inc

Lead Sponsor

Trials

2

Recruited

250+