Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05546268 · ClinicalTrials.gov registry record · Phase 1
Study of Oral MRT-2359 in Selected Cancer Patients
A Phase 1 study of Prostate Cancer and NSCLC, sponsored by Monte Rosa Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 174
- Enrollment target
- 17
- Study locations
NCT05546268: Active Phase 1 study of Prostate Cancer and NSCLC, sponsored by Monte Rosa Therapeutics.
NCT05546268 is a Phase 1 study of Prostate Cancer and NSCLC that is active but no longer recruiting, run by Monte Rosa Therapeutics. The registered enrollment target is 174 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (71% lower). The trial reports 17 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05546268, a Phase 1 study of Prostate Cancer and NSCLC, is active but no longer recruiting, sponsored by Monte Rosa Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 174 participants
- Enrollment target
- 17
- Study locations
Study Summary
This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer of any primary site, diffuse large B-cell lymphoma (DLBCL), and tumors with L-MYC or N-MYC amplification. Patients receive escalating doses of a GSPT1 molecular glue degrader MRT-2359 to determine safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of MRT-2359. Once the MTD and/or RP2D is identified, additional patients enroll to Phase 2 study, which includes molecular biomarkers stratification or selection, namely expression or amplification of L-MYC and N-MYC genes, hormone receptor positive (HR)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer and prostate cancer.
Conditions Studied
Interventions
- DRUG Oral MRT-2359
Study Locations (17)
Texas
- Mary Crowley Cancer Research - Dallas
- MD Anderson Cancer Center - Houston
- South Texas Accelerated Research Therapeutics (START) - San Antonio
Michigan
- Henry Ford Cancer Institute - Detroit
- South Texas Accelerated Research Therapeutics (START) Midwest - Grand Rapids
New York
- Memorial Sloan Kettering Cancer Center - New York
- Columbia University Irving Medical Centre - New York
Arizona
- Honor Health Research Institute - Scottsdale
California
- University of California San Diego - San Diego
Connecticut
- Yale University - New Haven
Kansas
- University of Kansas Cancer Center - Lawrence
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2022-10-12 |
| Est. Completion | 2027-11 |
| Phase | Phase 1 |
What the registry record for NCT05546268 still lists
NCT05546268 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (71% lower).
The record links to 8 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Oral MRT-2359 is the first listed.
NCT05546268 lists 17 locations in 13 states (Texas, Michigan, New York).
Frequently Asked Questions
What is clinical trial NCT05546268 about?
NCT05546268 is a clinical study titled "Study of Oral MRT-2359 in Selected Cancer Patients". This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer of any primary site, diffuse large B-cell lymphoma (DLBCL), and tumors w...
What is the current status of trial NCT05546268?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 174 participants. The study started on 2022-10-12. Estimated completion is 2027-11.
What conditions does trial NCT05546268 study?
This clinical trial studies the following conditions: Prostate Cancer, NSCLC, DLBCL, SCLC, HR Positive/HER-2 Negative Breast Cancer.
What interventions are being tested in trial NCT05546268?
The interventions under investigation include: Oral MRT-2359 (DRUG).
Who is sponsoring clinical trial NCT05546268?
This trial is sponsored by Monte Rosa Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05546268 being conducted?
This trial has 17 study locations across Arizona, California, Connecticut, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05546268's enrollment target sits among peer trials
174 247th of 735 higher than 488 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
Phase 1 Trial of ZM008 as Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
RECRUITING · Phase 1
-
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
RECRUITING · Phase 1
-
A Study to Learn How Safe AZD6621 is, How Well it Works, and How it Moves Throughout the Body Over Time, in Adult Male Participants With Metastatic Prostate Cancer
RECRUITING · Phase 1
-
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01000259 · 174 participants
Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
- NCT04884035 · 174 participants · Phase 1
Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma
- NCT05075980 · 174 participants · Phase 2
Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study
- NCT05846685 · 174 participants
Patient Perspectives of an Automated Falls-Risk Screening and Referral Tool in the Emergency Department (ED)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI