> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-study-of-ifinatamab-deruxtecan-i-dxd-in-people-56fce060-49d9-425a-b6b7-c3a1f8ae972e > Record changed: 2026-10-13 # A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) NCT06925737 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) Participants 1,440 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) Start date 2025-05-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) Number of sites 295 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) ## Title and summary **Summary** Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Short title** A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Official title** A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) ## Dates **Completion date** 2031-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **First posted** 2025-04-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Primary completion date** 2028-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Start date** 2025-05-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) ## Size and sites **Participants** 1,440 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Planned participants** 1,440 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Number of sites** 295 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) ## Identifiers **Registry ID** NCT06925737 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **ClinicalTrials.gov ID** NCT06925737 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) ## Outcomes ### Primary outcomes 1. Overall Survival (OS) Timeframe: Up to approximately 36 months OS is defined as the time from randomization to death due to any cause. 2. Radiographic Progression Free Survival (rPFS) Timeframe: Up to approximately 36 months rPFS is defined as the time from randomization to the first documented disease progression per prostate cancer working group (PCWG)-modifed Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. ### Secondary outcomes 1. Time to First Subsequent Therapy (TFST) Timeframe: Up to approximately 36 months TFST is defined as the time from randomization to initiation of the first subsequent anticancer therapy or death, whichever occurs first. 2. Objective Response Rate (ORR) Timeframe: Up to approximately 36 months The ORR is defined as a confirmed complete response (CR) or partial response (PR) per PCWG-modified RECIST 1.1 as assessed by BICR. 3. Duration of Response (DOR) Timeframe: Up to approximately 36 months For participants who demonstrate confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression per PCWG-modified RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first. 4. Time to Pain Progression (TTPP) Timeframe: Up to approximately 36 months TTPP is defined as the time from randomization to pain progression based on the brief pain inventory-short form (BPI-SF) Item 3 "worst pain in 24 hours" and opiate analgesic use (AQA score). 5. Time to Prostate-specific Antigen (PSA) Progression Timeframe: Up to approximately 36 months Time to PSA progression is defined as the time from randomization to PSA progression. The PSA progression date is defined as the first date that 1) ≥25% increase and ≥2 ng/mL above the nadir which is confirmed by a second value≥3 weeks later if there is PSA decline from baseline, 2) ≥25% increase and ≥2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline. 6. PSA Response Rate Timeframe: Up to approximately 36 months PSA response rate is defined as the proportion of participants in the analysis population who have a PSA reduction of ≥50% from baseline with a consecutive confirmation assessment at least 3 weeks later per PCWG criteria. 7. Time to First Symptomatic Skeletal-Related Event (SSRE) Timeframe: Up to approximately 36 months Time to first SSRE is defined as the time from randomization to the first occurrence of any of the following symptomatic skeletal-related events: 1\. use of EBRT to prevent or relieve skeletal symptoms, 2\. new symptomatic pathologic bone fracture (vertebral or non-vertebral), 3\. spinal cord compression, 4\. a tumor-related orthopedic surgical intervention. 8. Number of Participants Who Experienced at Least One Adverse Event (AE) Timeframe: Up to approximately 36 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. 9. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) Timeframe: Up to approximately 36 months An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) ## Eligibility **Sex** Male **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria The main inclusion criteria include but are not limited to the following: - Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology - Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening - Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI) - Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment - Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy - Has recovered from adverse events (AEs) due to previous anticancer therapies ### Exclusion criteria The main exclusion criteria include but are not limited to the following: - Is unable to swallow tablets/capsules - Has any of the following indicators of interstitial lung disease (ILD)/pneumonitis: 1. Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids 2. Has current ILD/pneumonitis 3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out - Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses - Has uncontrolled or significant cardiovascular disease - Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC) - Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities - Has a "superscan" bone scan Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) ## Sites - Mayo Clinic in Arizona - Phoenix ( Site 0044)Phoenix, United StatesRecruiting - City of Hope Comprehensive Cancer Center ( Site 0049)Duarte, United StatesRecruiting - City of Hope Lennar Foundation Cancer Center ( Site 0059)Irvine, United StatesRecruiting - Moores Cancer Center ( Site 0010)La Jolla, United StatesRecruiting - Veterans Affairs Long Beach Healthcare System ( Site 0058)Long Beach, United StatesRecruiting - Cedars-Sinai Medical Center ( Site 0068)Los Angeles, United StatesRecruiting - UCLA Hematology/Oncology - Santa Monica ( Site 0002)Los Angeles, United StatesRecruiting - University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0006)Orange, United StatesRecruiting - Stanford Cancer Center ( Site 0046)Palo Alto, United StatesRecruiting - Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0053)Aurora, United StatesRecruiting - Yale-New Haven Hospital-Yale Cancer Center ( Site 0050)New Haven, United StatesRecruiting - Veterans Affairs Connecticut Healthcare System ( Site 0062)West Haven, United StatesRecruiting - The GW Medical Faculty Associates ( Site 0057)Washington D.C., United StatesRecruiting - Washington DC Veterans Affairs Medical Center ( Site 0056)Washington D.C., United StatesRecruiting - Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0077)Jacksonville, United StatesRecruiting - Emory University School of Medicine- Grady Campus ( Site 0103)Atlanta, United StatesRecruiting - Winship Cancer Institute, Emory University ( Site 0003)Atlanta, United StatesRecruiting - Rush University Medical Center-Hematology and Oncology ( Site 0028)Chicago, United StatesRecruiting - University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0063)Chicago, United StatesRecruiting - University of Kentucky Chandler Medical Center ( Site 0048)Lexington, United StatesRecruiting - Greenebaum Comprehensive Cancer Center ( Site 0021)Baltimore, United StatesRecruiting - Beth Israel Deaconess Medical Center ( Site 0043)Boston, United StatesRecruiting - Dana Farber Cancer Institute ( Site 0012)Boston, United StatesRecruiting - University of Michigan ( Site 0005)Ann Arbor, United StatesRecruiting - Henry Ford Hospital ( Site 0035)Detroit, United StatesRecruiting And 270 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) ## References - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](http://www.merckclinicaltrials.com/) ### Other registry identifiers (3) - MK-2400-001 - U1111-1312-2498 - 2024-517423-40-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06925737) ## Related records ### Drugs (4) - [Cetirizine hydrochloride](https://trialight.com/data/asset/cetirizine-hydrochloride-0f5b8ec9-315b-492f-b7a3-de74652b5fd2.md) - [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md) - [Ifinatamab deruxtecan](https://trialight.com/data/asset/ifinatamab-deruxtecan-31d740bc-d158-4964-a2dd-567df38e9e3d.md) - [Prednisone](https://trialight.com/data/asset/prednisone-a5a99f90-5fbe-45c2-a625-34ba78735da6.md) ### Collaborators (1) - [Daiichi Sankyo](https://trialight.com/data/company/daiichi-sankyo-3b5789c1-b2e3-4a47-8ee5-e5e8854d8958.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Conditions (1) - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) Primary condition ### Targets (17) - [HRH1](https://trialight.com/data/target/hrh1-066d4575-4b1c-5ce9-adf8-b080f76b770b.md) - [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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