Clinical trial · Interventional
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)
MK-2400-01A Substudy: A Phase 1/2, Open-label Umbrella Substudy of MK-2400-U01 Master Protocol to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan-based Treatment Combinations or Ifinatamab Deruxtecan Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (IDeate-Prostate02)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 18, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260918-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-Resistant Prostatic Cancer | — | UNRESOLVED | — |
| Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone | Drug | Abiraterone | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Ifinatamab Deruxtecan | Drug | — | UNRESOLVED |
| Opevesostat | Drug | — | UNRESOLVED |
| Rescue Medication | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel
- description
- Participants will receive docetaxel at a determined dose every 3 weeks (Q3W) for a maximum of 10 cycles. Each cycle is 21 days.
- interventionNames
- Drug: Docetaxel
- type
- EXPERIMENTAL
- label
- Ifinatamab Deruxtecan (I-DXd)
- description
- Participants will receive I-DXd at a determined dose Q3W until unacceptable toxicity, progressive disease (PD), death or withdrawal of consent.
- interventionNames
- Drug: Ifinatamab Deruxtecan
- Drug: Rescue Medication
- type
- EXPERIMENTAL
- label
- I-DXd + Opevesostat
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 distant 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: * Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), current ILD, clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out * 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
References
Publications (0)
Data not yet available