Study of Oral MRT-2359 With Apalutamide in Prostate Cancer
NCT07745361 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-08-04
Summary
This Phase 2, open-label, multicenter study is conducted in patients with castration-resistant prostate cancer.
Patients in this study receive MRT-2359, an investigational oral medicine, in combination with apalutamide, an oral medicine used to treat prostate cancer. The main purpose of the study is to assess whether this treatment combination can lower prostate-specific antigen (PSA) The study will also evaluate the safety and tolerability of the treatment combination and assess additional measures of anti-tumor activity.
Conditions
- Castration-Resistant Prostate Cancer (CRPC)
- Castration-Resistant Prostate Cancer
- Prostate Cancer
- Prostate Cancer (Adenocarcinoma)
Interventions
- DRUG
-
Oral MRT-2359
Orally administered tablets of MRT-2359
- DRUG
-
Apalutamide
Orally administered apalutamide
Sponsors & Collaborators
-
Monte Rosa Therapeutics, Inc
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2027-10-31
- Completion
- 2028-04-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study of Single-Agent AT-101 in Men With Hormone Refractory Prostate Cancer
NCT00286806 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
NCT02531516 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC)
NCT01171898 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer
NCT01251861 ·Status: COMPLETED ·Phase: PHASE2
-
Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
NCT00887198 ·Status: COMPLETED ·Phase: PHASE3
-
Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer
NCT03098836 ·Status: COMPLETED ·Phase: PHASE2
-
The Study of Olaparib in Newly Diagnosed mCRPC Patients With HRR Gene Mutation
NCT05262608 ·Status: UNKNOWN ·Phase: PHASE2
-
Safety and Efficacy of Atrasentan in Men With Hormone Naive Prostate Cancer Exhibiting Early Signs of Biochemical Failure
NCT00038662 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT02711956 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
AZD2171 to Treat Prostate Cancer
NCT00436956 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Atrasentan in Men With Metastatic, Hormone-Refractory Prostate Cancer
NCT00036543 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
NCT07311694 ·Status: RECRUITING ·Phase: PHASE3
-
A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer
NCT02991911 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants
NCT06559007 ·Status: COMPLETED ·Phase: PHASE1
-
Sequencing Abiraterone and Enzalutamide in mCRPC
NCT02125357 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy
NCT02217566 ·Status: COMPLETED ·Phase: PHASE2
-
Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer
NCT03360721 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
NCT07226986 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
NCT06059118 ·Status: RECRUITING ·Phase: PHASE2
-
Safety and Efficacy of CC-4047 in Subjects With Metastatic Hormone Refractory Prostate Cancer (HRPC)
NCT00072722 ·Status: COMPLETED ·Phase: PHASE2
-
An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)
NCT02257736 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer
NCT00521781 ·Status: TERMINATED ·Phase: PHASE2
-
Phase 1 Study of ACE-232 to Treat Patients With Metastatic Castration-Resistant Prostate Cancer
NCT06801236 ·Status: RECRUITING ·Phase: PHASE1
-
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer
NCT07570979 ·Status: RECRUITING ·Phase: PHASE1
-
Study of CEP-701 in Treatment of Prostate Cancer
NCT00081601 ·Status: COMPLETED ·Phase: PHASE2