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)
Recruiting · NCT06863272 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 7 US states.
- UCLA Hematology & Oncology ( Site 0003) - Los Angeles, California, United States
- University of California-Irvine Medical Center ( Site 0016) - Orange, California, United States
- UCSF Medical Center at Mission Bay ( Site 0034) - San Francisco, California, United States
- MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026) - Washington D.C., District of Columbia, United States
- University of Michigan ( Site 0021) - Ann Arbor, Michigan, United States
- Memorial Sloan Kettering Cancer Center ( Site 0006) - New York, New York, United States
- UPMC Hillman Cancer Center ( Site 0014) - Pittsburgh, Pennsylvania, United States
- The West Clinic, PLLC dba West Cancer Center ( Site 0005) - Germantown, Tennessee, United States
- Fred Hutchinson Cancer Center ( Site 0013) - Seattle, Washington, United States
- Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0650) - Adana, Turkey (Türkiye)
- Hacettepe Universitesi Tip Fakultesi ( Site 0648) - Ankara, Turkey (Türkiye)
- Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0653) - Ankara, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi ( Site 0654) - Ankara, Turkey (Türkiye)
- Auckland City Hospital ( Site 0831) - Auckland, New Zealand
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 0432) - Brescia, Italy
- Beaumont Hospital, Dublin ( Site 0465) - Dublin, Ireland
- Tallaght University Hospital ( Site 0462) - Dublin, Ireland
- Rambam Health Care Campus ( Site 0400) - Haifa, Israel
- Universitaetsklinikum Hamburg-Eppendorf ( Site 0524) - Hamburg, Germany
- Koç Üniversitesi Hastanesi ( Site 0656) - Istanbul, Turkey (Türkiye)
- Istanbul Universitesi Cerrahpasa ( Site 0649) - Istanbul, Turkey (Türkiye)
- Hadassah Medical Center ( Site 0404) - Jerusalem, Israel
- Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200) - La Rioja, Argentina
- Hospital Universitario Ramon y Cajal ( Site 0620) - Madrid, Spain
- Hospital Clinico San Carlos ( Site 0618) - Madrid, Spain
- Hospital Universitario 12 de Octubre ( Site 0622) - Madrid, Spain
- Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0431) - Milan, Italy
- A.O.U. Federico II di Napoli ( Site 0435) - Naples, Italy
- Rabin Medical Center ( Site 0402) - Petah Tikva, Israel
- Sheba Medical Center ( Site 0401) - Ramat Gan, Israel
- Recep Tayyip Erdogan University Training and Research Hospital ( Site 0655) - Rize, Turkey (Türkiye)
- Fondazione Policlinico Universitario Agostino Gemelli ( Site 0433) - Roma, Italy
- Severance Hospital Yonsei University Health System ( Site 0924) - Seoul, South Korea
- Samsung Medical Center ( Site 0926) - Seoul, South Korea
- Hospital Universitario Virgen del Rocio ( Site 0619) - Seville, Spain
- IPITEC ( Site 0275) - São Paulo, Brazil
- IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0269) - São Paulo, Brazil
- Taichung Veterans General Hospital ( Site 0902) - Taichung, Taiwan
- Taipei Veterans General Hospital ( Site 0901) - Taipei, Taiwan
- Sourasky Medical Center ( Site 0403) - Tel Aviv, Israel
- NCT ( Site 0528) - Heidelberg, Baden-Wurttemberg, Germany
- Universitaetsklinikum Ulm. ( Site 0530) - Ulm, Baden-Wurttemberg, Germany
- ICO L Hospitalet ( Site 0617) - L Hospitalet Del Llobregat, Barcelona, Spain
- BC Cancer - Vancouver Center ( Site 0103) - Vancouver, British Columbia, Canada
- Instituto Alexander Fleming ( Site 0202) - Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
- Addenbrooke's Hospital ( Site 0747) - Cambridge, Cambridgeshire, United Kingdom
- St Vincent's University Hospital ( Site 0463) - Dublin, Dublin, Ireland
- Ziekenhuis Gelderse Vallei ( Site 0683) - Ede, Gelderland, Netherlands
- UMC St. Radboud ( Site 0679) - Nijmegen, Gelderland, Netherlands
- Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0498) - Bordeaux, Gironde, France
- Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0590) - Poznan, Greater Poland Voivodeship, Poland
- St Bartholomew's Hospital ( Site 0749) - London, London, City of, United Kingdom
- Royal Free Hospital ( Site 0743) - London, London, City of, United Kingdom
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0586) - Warsaw, Masovian Voivodeship, Poland
- Clinica Universidad Catolica del Maule ( Site 0236) - Talca, Maule Region, Chile
- Macquarie University-MQ Health Clinical Trials Unit ( Site 0801) - Macquarie University, New South Wales, Australia
- Centre Oscar Lambret ( Site 0495) - Lille, Nord, France
- Sunnybrook Research Institute ( Site 0109) - Toronto, Ontario, Canada
- Princess Margaret Cancer Centre ( Site 0102) - Toronto, Ontario, Canada
- Institut De Cancerologie De L Ouest ( Site 0494) - Saint-Herblain, Pays de la Loire Region, France
Showing 60 of 82 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →