A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)

Clinicaltrials.gov ID: NCT06863272
db-list-check Status RECRUITING
b-loader Phase PHASE1, PHASE2
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 360

Conditions

Castration-Resistant Prostatic Cancer, Metastasis

Drugs

Docetaxel, Ifinatamab Deruxtecan, MK-5684, Abiraterone, Enzalutamide

Summary

The purpose of this substudy is to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd), given alone or with other treatments in participants with metastatic castration-resistant prostate cancer (mCRPC). The goals of this study are to learn about:* The safety of the study treatment and if people tolerate it. * A safe dose level of I-DXd that can be used with other treatments. * Participant levels of prostate specific antigen (PSA) during treatment.

Detailed Description

This sub study MK-2400-01A assesses treatments for metastatic castration-resistant prostate cancer (mCRPC).

The master screening protocol is MK-2400-U01.

Locations

2 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Study Coordinator
  • 202-877-3061

Study Director

  • Medical Director

Status

  • RECRUITING

Contact Person

  • Study Coordinator
  • 901-683-0055

Study Director

  • Medical Director

Eligibility Criteria

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 before Screening
* Has current evidence of metastatic disease
* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after treatment
* Participants receiving bone resorptive therapy (including, but not limited to bisphosphonate or denosumab) must have been on stable doses for ≥4 weeks before allocation/randomization
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 10 days before allocation/randomization
* Has prior treatment with poly-ADP-ribose polymerase inhibitors (PARPi) if indicated by local approved regimen or were deemed ineligible to receive PARPi by the investigator

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, or has current ILD/pneumonitis or suspected ILD/pneumonitis
* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
* Uncontrolled or significant cardiovascular disease
* History of pituitary dysfunction
* Poorly controlled diabetes mellitus
* History or current condition of adrenal insufficiency (eg, Addison's disease)
* Has received prior treatment with taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC).
* Chronic steroid treatment (dose of >10 mg daily prednisone equivalent), except for low-dose inhaled steroids (for asthma/chronic obstructive pulmonary disease), topical steroids (for mild skin conditions), or intra-articular steroid injections
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Active autoimmune disease that has required systemic treatment in the past 2 years
* History of allogeneic tissue/solid organ transplant

Study Plan

Docetaxel

ACTIVE_COMPARATOR

Participants will receive docetaxel at a determined dose every 3 weeks (Q3W) for a maximum of 10 cycles. Each cycle is 21 days.

  • DRUG:

    Docetaxel

    Description:

    Administered via Intravenous (IV) infusion at a specified dose on specified days

Ifinatamab Deruxtecan (I-DXd)

EXPERIMENTAL

Participants will receive I-DXd at a determined dose Q3W until unacceptable toxicity, progressive disease (PD), death or withdrawal of consent.

  • DRUG:

    Ifinatamab Deruxtecan

    Description:

    Administered via IV infusion at a specified dose on specified days

I-DXd + MK-5684

EXPERIMENTAL

Following a dose escalation regimen with I-DXd, participants will receive I-DXd at a determined dose until unacceptable toxicity, PD, death or withdrawal of consent PLUS MK-5684 at a determined dose until any of the criterion for discontinuation of study intervention is met.

  • DRUG:

    Ifinatamab Deruxtecan

    Description:

    Administered via IV infusion at a specified dose on specified days
  • DRUG:

    MK-5684

    Description:

    Administered orally at a specified dose on specified days

I-DXd +ARPI (Abiraterone or Enzalutamide)

EXPERIMENTAL

Following a dose escalation regimen with I-DXd, participants will receive I-DXd at a determined dose until unacceptable toxicity, PD, death or withdrawal of consent PLUS ARPI (Androgen Receptor Pathway Inhibitor) - Abiraterone acetate OR Enzalutamide at a determined dose until any of the criterion for discontinuation of study intervention is met.

  • DRUG:

    Ifinatamab Deruxtecan

    Description:

    Administered via IV infusion at a specified dose on specified days
  • DRUG:

    Abiraterone

    Description:

    Administered orally at a specified dose on specified days
  • DRUG:

    Enzalutamide

    Description:

    Administered orally at a specified dose on specified days

Outcome Measures

Primary Outcome Measures

Efficacy Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only

Time Frame: Up to approximately 21 days

Efficacy Phase: Number of Participants Who Experienced an Adverse Event (AE)

Time Frame: Up to approximately 54 months

Efficacy Phase: Number of Participants Who Discontinued Study Intervention Due to an AE

Time Frame: Up to approximately 24 months

Efficacy Phase: Prostate-Specific Antigen (PSA) response rate

Time Frame: Up to approximately 54 months

Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only

Time Frame: Up to approximately 21 days

Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE) - Combination Arms Only

Time Frame: Up to approximately 21 days

Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE - Combination Arms Only

Time Frame: Up to approximately 21 days

Secondary Outcome Measures

Objective Response Rate (ORR)

Time Frame: Up to approximately 54 months

Radiographic Progression-Free Survival (rPFS)

Time Frame: Up to approximately 54 months

Overall Survival (OS)

Time Frame: Up to approximately 54 months

Duration of Response (DOR)

Time Frame: Up to approximately 54 months

Time from allocation/randomization to initiation of the first subsequent anticancer therapy (TFST)

Time Frame: Up to approximately 54 months

Time to Prostate-Specific Antigen (PSA) Progression

Time Frame: Up to approximately 54 months

Time to pain progression (TTPP)

Time Frame: Up to approximately 54 months

Timeline

  • Last Updated
    December 11, 2025
  • Start Date
    March 7, 2025
  • Today
    December 19, 2025
  • Completion Date ( Estimated )
    February 24, 2030

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