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NCT06863272 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Metastasis and Castration Resistant Prostatic Cancer, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 360
- Enrollment target
- 20
- Study locations
NCT06863272: Recruiting Phase 1 study of Metastasis and Castration Resistant Prostatic Cancer, sponsored by Merck Sharp & Dohme.
NCT06863272 is a Phase 1 study of Metastasis and Castration Resistant Prostatic Cancer that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 360 participants, above the 70-participant average among 15 other Metastasis trials with a reported enrollment target (414% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06863272, a Phase 1 study of Metastasis and Castration Resistant Prostatic Cancer, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 360 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The following events if considered drug related by the Investigator, will be considered a DLT: Grade 4 nonhematologic toxicity (not based on laboratory value); Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia of any duration; Grade 3 thrombocytopenia associated with clinically significant bleeding; Nonhematologic AEs ≥Grade 3 with exceptions; Grade 3 or Grade 4 non-hematologic laboratory values if requires medical intervention, leads to hospitalizat
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Enzalutamide
- DRUG Abiraterone
- DRUG Ifinatamab Deruxtecan
- DRUG MK-5684
Study Locations (20)
Other
- Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200) - La Rioja
- IPITEC ( Site 0275) - São Paulo
- IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0269) - São Paulo
São Paulo
- Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0268) - Bragança Paulista
- Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0263) - São José do Rio Preto
- Hospital Alemao Oswaldo Cruz ( Site 0279) - São Paulo
Rio Grande do Sul
- Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0270) - Porto Alegre
- Hospital Moinhos de Vento ( Site 0278) - Porto Alegre
Ontario
- Sunnybrook Research Institute ( Site 0109) - Toronto
- Princess Margaret Cancer Centre ( Site 0102) - Toronto
California
- UCSF Medical Center at Mission Bay ( Site 0034) - San Francisco
District of Columbia
- MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026) - Washington D.C.
Pennsylvania
- UPMC Hillman Cancer Center ( Site 0014) - Pittsburgh
Tennessee
- The West Clinic, PLLC dba West Cancer Center ( Site 0005) - Germantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2025-07-03 |
| Est. Completion | 2030-02-24 |
| Phase | Phase 1 |
What NCT06863272 shows while recruiting
NCT06863272 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, above the 70-participant average among 15 other Metastasis trials with a reported enrollment target (414% higher).
The record links to 2 conditions, with Metastasis appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.
NCT06863272 names 20 study sites across 14 states, led by Other, São Paulo, Rio Grande do Sul.
Frequently Asked Questions
What is clinical trial NCT06863272 about?
NCT06863272 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT06863272?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 360 participants. The study started on 2025-07-03. Estimated completion is 2030-02-24.
What conditions does trial NCT06863272 study?
This clinical trial studies the following conditions: Metastasis, Castration Resistant Prostatic Cancer.
What interventions are being tested in trial NCT06863272?
The interventions under investigation include: Docetaxel (DRUG), Enzalutamide (DRUG), Abiraterone (DRUG), Ifinatamab Deruxtecan (DRUG), MK-5684 (DRUG).
Who is sponsoring clinical trial NCT06863272?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06863272 being conducted?
This trial has 20 study locations across California, District of Columbia, Pennsylvania, Tennessee, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06863272's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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