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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 3

Conditions: Prostatic Neoplasms; Prostate Cancer

Treatments: Drug: Prednisone; Drug: Ifinatamab deruxtecan; Drug: Docetaxel; Drug: Rescue Medication

Study type: Interventional

Funder types: Industry

Identifiers

NCT06925737

2400-001

2024-517423-40-00 (Registry Identifier)

MK-2400-001 (Other Identifier)

U1111-1312-2498 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,440 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,440 participants in 2 patient groups

I-DXd

Experimental group

Description:

Participants receive I-DXd 12mg/kg every 3 weeks (q3w)

Treatment:

Drug: Rescue Medication

Drug: Ifinatamab deruxtecan

Docetaxel

Active Comparator group

Description:

Participants receive docetaxel 75 mg/m\^2 q3w and prednisone 10 mg/day or per approved product label

Treatment:

Drug: Docetaxel

Drug: Prednisone