A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)

Phase 3

Recruiting

• Conditions: Prostate Cancer; Prostatic Neoplasms
• Interventions: Drug: Ifinatamab deruxtecan; Drug: Docetaxel; Drug: Prednisone

• Registration Number: NCT06925737
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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,

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-07
• Study First Posted: 2025-04-13
• Status Verified: 2025-05
• Study Start: 2025-05-13
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-20
• Primary Completion: 2028-06-26
• Study Completion: 2031-01-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 1440

Inclusion Criteria

The main inclusion criteria include but are not limited to the following:

• Has diagnosis of metastatic castration-resistant prostate cancer (mCRPC)
• Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to entering the study
• Has received prior treatment with 1 or 2 androgen receptor pathway inhibitor (ARPI) and progressed during or after at least 8 weeks of treatment

Exclusion Criteria

The main exclusion criteria include but are not limited to the following:

• History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids
• Has uncontrolled or significant cardiovascular disease
• Has received prior treatment with a taxane-based chemotherapy agent for mCRPC

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I-DXd	Ifinatamab deruxtecan	Participants receive I-DXd 12mg/kg every 3 weeks (q3w)
Docetaxel	Docetaxel	Participants receive docetaxel 75 mg//m\^2 q3w and prednisone 10 mg/day or per approved product label
Docetaxel	Prednisone	Participants receive docetaxel 75 mg//m\^2 q3w and prednisone 10 mg/day or per approved product label

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to approximately 36 months	OS is defined as the time from randomization to death due to any cause.
Radiographic Progression Free Survival (rPFS)	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 Outcome Measures

Name	Time	Method
Objective Response (OR)	Up to approximately 36 months	The OR is defined as a confirmed complete response (CR) or partial response (PR) per PCWG-modified RECIST 1.1 as assessed by BICR.
Time to First Subsequent Therapy (TFST)	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.
Duration of Response (DOR)	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.
Time to Pain Progression (TTPP)	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).
Time to Prostate-specific Antigen (PSA) Progression	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.
PSA Response	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
Time to First Symptomatic Skeletal-related Event (SSRE)	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.
Number of Participants Who Experienced at least One Adverse Event (AE)	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.
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)	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.

Trial Locations

Locations (7)

Cancer and Hematology Centers of Western Michigan ( Site 0015); 🇺🇸 Grand Rapids, Michigan, United States

St. Vincent Frontier Cancer Center-Research ( Site 0037); 🇺🇸 Billings, Montana, United States

Blue Ridge Cancer Care ( Site 0024); 🇺🇸 Roanoke, Virginia, United States

Rambam Health Care Campus ( Site 0462); 🇮🇱 Haifa, Israel

Sheba Medical Center ( Site 0460); 🇮🇱 Ramat Gan, Israel

Ulsan University Hospital ( Site 0793); 🇰🇷 Dong-gu, Ulsan-Kwangyokshi, Korea, Republic of

National Taiwan University Hospital ( Site 0870); 🇨🇳 Taiwan, Taipei, Taiwan