~54 spots leftby May 2026

MRT-2359 for Solid Tumors

Recruiting in Palo Alto (17 mi)
+20 other locations
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
+4 more

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.
+14 more

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

Participant Groups

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.
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 Clinic Near You

Research Locations NearbySelect from list below to view details:
Washington UniversitySaint Louis, MO
Mary Crowley Cancer ResearchDallas, TX
Moffitt Cancer CenterTampa, FL
Sarah Cannon Research InstituteNashville, TN
More Trial Locations
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Who Is Running the Clinical Trial?

Monte Rosa Therapeutics, IncLead Sponsor

References