Actively Recruiting
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)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-08
360
Participants Needed
78
Research Sites
299 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed prostate adenocarcinoma without small cell histology
- Prostate cancer progression while on androgen deprivation therapy or after bilateral orchiectomy within 6 months before screening
- Evidence of metastatic disease
- Prior treatment with 1 or 2 androgen receptor pathway inhibitors and disease progression during or after treatment
- Stable doses of bone resorptive therapy for at least 4 weeks before randomization if receiving
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization
- Prior treatment with poly-ADP-ribose polymerase inhibitors if indicated or deemed ineligible by investigator
You will not qualify if you...
- History of non-infectious interstitial lung disease or pneumonitis requiring steroids, or current/suspected ILD/pneumonitis
- Severe pulmonary compromise from other lung illnesses
- Uncontrolled or significant cardiovascular disease
- History of pituitary dysfunction
- Poorly controlled diabetes mellitus
- History or current adrenal insufficiency
- Prior taxane-based chemotherapy for metastatic castration-resistant prostate cancer
- Chronic steroid treatment over 10 mg daily prednisone equivalent except certain low-dose or topical steroids
- Radiotherapy within 2 weeks before study start or radiation-related toxicities needing corticosteroids
- Active malignancy requiring treatment within past 3 years
- Known active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease treated systemically in past 2 years
- History of allogeneic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 78 locations
1
UCLA Hematology & Oncology ( Site 0003)
Los Angeles, California, United States, 90095
Actively Recruiting
2
UCSF Medical Center at Mission Bay ( Site 0034)
San Francisco, California, United States, 94158
Actively Recruiting
3
MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026)
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center ( Site 0006)
New York, New York, United States, 10065
Actively Recruiting
5
UPMC Hillman Cancer Center ( Site 0014)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
6
The West Clinic, PLLC dba West Cancer Center ( Site 0005)
Germantown, Tennessee, United States, 38138
Actively Recruiting
7
Fred Hutchinson Cancer Center ( Site 0013)
Seattle, Washington, United States, 98109
Actively Recruiting
8
Instituto Alexander Fleming ( Site 0202)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
Actively Recruiting
9
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200)
La Rioja, Argentina, F5300COE
Actively Recruiting
10
Macquarie University-MQ Health Clinical Trials Unit ( Site 0801)
Macquarie University, New South Wales, Australia, 2109
Actively Recruiting
11
Liga Norte Riograndense Contra o Câncer ( Site 0271)
Natal, Rio Grande do Norte, Brazil, 59062-000
Actively Recruiting
12
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0270)
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Actively Recruiting
13
Hospital Moinhos de Vento ( Site 0278)
Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
Actively Recruiting
14
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0268)
Bragança Paulista, São Paulo, Brazil, 12916-542
Actively Recruiting
15
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) ( Site 0273)
Ribeirão Preto, São Paulo, Brazil, 14048900
Actively Recruiting
16
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0263)
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
17
Hospital Alemao Oswaldo Cruz ( Site 0279)
São Paulo, São Paulo, Brazil, 01327-001
Actively Recruiting
18
IPITEC ( Site 0275)
São Paulo, Brazil, 01221-020
Actively Recruiting
19
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0269)
São Paulo, Brazil, 03102-006
Actively Recruiting
20
BC Cancer - Vancouver Center ( Site 0103)
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
21
Sunnybrook Research Institute ( Site 0109)
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
22
Princess Margaret Cancer Centre ( Site 0102)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
23
Jewish General Hospital ( Site 0108)
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
24
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0107)
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
25
Clinica Universidad Catolica del Maule ( Site 0236)
Talca, Maule Region, Chile, 3465584
Actively Recruiting
26
FALP ( Site 0232)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
27
Centro de Oncología de Precisión ( Site 0241)
Santiago, Region M. de Santiago, Chile, 7560908
Actively Recruiting
28
Bradfordhill ( Site 0231)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
29
ONCOCENTRO APYS ( Site 0234)
Viña del Mar, Valparaiso, Chile, 2520598
Actively Recruiting
30
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0498)
Bordeaux, Gironde, France, 33000
Actively Recruiting
31
Centre Oscar Lambret ( Site 0495)
Lille, Nord, France, 59000
Actively Recruiting
32
Institut De Cancerologie De L Ouest ( Site 0494)
Saint-Herblain, Pays de la Loire Region, France, 44800
Actively Recruiting
33
Centre Hospitalier de la Côte Basque ( Site 0496)
Bayonne, Pyrenees-Atlantiques, France, 64100
Actively Recruiting
34
centre hospitalier lyon sud ( Site 0497)
Pierre-Bénite, Rhone, France, 69310
Actively Recruiting
35
NCT ( Site 0528)
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
36
Universitaetsklinikum Jena ( Site 0525)
Jena, Thuringia, Germany, 07747
Actively Recruiting
37
Universitaetsklinikum Hamburg-Eppendorf ( Site 0524)
Hamburg, Germany, 20246
Actively Recruiting
38
St Vincent's University Hospital ( Site 0463)
Dublin, Dublin, Ireland, D04 T6F4
Actively Recruiting
39
Beaumont Hospital, Dublin ( Site 0465)
Dublin, Ireland, D09 V2N0
Actively Recruiting
40
Tallaght University Hospital ( Site 0462)
Dublin, Ireland, D24 NR0A
Actively Recruiting
41
Rambam Health Care Campus ( Site 0400)
Haifa, Israel, 3109601
Actively Recruiting
42
Rabin Medical Center ( Site 0402)
Petah Tikva, Israel, 4941492
Actively Recruiting
43
Sheba Medical Center ( Site 0401)
Ramat Gan, Israel, 5265601
Actively Recruiting
44
Sourasky Medical Center ( Site 0403)
Tel Aviv, Israel, 6423906
Actively Recruiting
45
AOU San Luigi Gonzaga di Orbassano ( Site 0434)
Orbassano, Torino, Italy, 10143
Actively Recruiting
46
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 0432)
Brescia, Italy, 25123
Actively Recruiting
47
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0431)
Milan, Italy, 20133
Actively Recruiting
48
A.O.U. Federico II di Napoli ( Site 0435)
Naples, Italy, 80131
Actively Recruiting
49
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0433)
Roma, Italy, 00168
Actively Recruiting
50
Ziekenhuis Gelderse Vallei ( Site 0683)
Ede, Gelderland, Netherlands, 6716 RP
Actively Recruiting
51
UMC St. Radboud ( Site 0679)
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
52
Nij Smellinghe ( Site 0684)
Drachten, Provincie Friesland, Netherlands, 9202 NN
Actively Recruiting
53
Auckland City Hospital ( Site 0831)
Auckland, New Zealand, 1023
Actively Recruiting
54
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0590)
Poznan, Greater Poland Voivodeship, Poland, 60-355
Actively Recruiting
55
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0586)
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
56
Uniwersyteckie Centrum Kliniczne ( Site 0588)
Gdansk, Pomeranian Voivodeship, Poland, 80-214
Actively Recruiting
57
Szpital Wojewódzki im. M.Kopernika Oddział Onk. Klinicznej z Pododdziałem Chemioterapii Jednodniowej ( Site 0587)
Koszalin, West Pomeranian Voivodeship, Poland, 75-581
Actively Recruiting
58
Asan Medical Center ( Site 0925)
Songpagu, Seoul, South Korea, 05505
Actively Recruiting
59
Severance Hospital Yonsei University Health System ( Site 0924)
Seoul, South Korea, 03722
Active, Not Recruiting
60
Samsung Medical Center ( Site 0926)
Seoul, South Korea, 06351
Actively Recruiting
61
ICO L Hospitalet ( Site 0617)
L Hospitalet Del Llobregat, Barcelona, Spain, 08908
Actively Recruiting
62
Hospital Universitario Ramon y Cajal ( Site 0620)
Madrid, Spain, 28034
Actively Recruiting
63
Hospital Clinico San Carlos ( Site 0618)
Madrid, Spain, 28040
Actively Recruiting
64
Hospital Universitario 12 de Octubre ( Site 0622)
Madrid, Spain, 28041
Actively Recruiting
65
Hospital Universitario Virgen del Rocio ( Site 0619)
Seville, Spain, 41013
Actively Recruiting
66
Taichung Veterans General Hospital ( Site 0902)
Taichung, Taiwan, 40705
Actively Recruiting
67
Taipei Veterans General Hospital ( Site 0901)
Taipei, Taiwan, 11217
Actively Recruiting
68
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0650)
Adana, Turkey (Türkiye), 01250
Actively Recruiting
69
Hacettepe Universitesi Tip Fakultesi ( Site 0648)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
70
Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0653)
Ankara, Turkey (Türkiye), 06620
Actively Recruiting
71
Ankara Bilkent Şehir Hastanesi ( Site 0654)
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
72
Koç Üniversitesi Hastanesi ( Site 0656)
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
73
Istanbul Universitesi Cerrahpasa ( Site 0649)
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
74
Recep Tayyip Erdogan University Training and Research Hospital ( Site 0655)
Rize, Turkey (Türkiye), 53020
Actively Recruiting
75
Addenbrooke's Hospital ( Site 0747)
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Actively Recruiting
76
St Bartholomew's Hospital ( Site 0749)
London, London, City of, United Kingdom, EC1A 7BE
Actively Recruiting
77
Royal Free Hospital ( Site 0743)
London, London, City of, United Kingdom, NW3 2QG
Actively Recruiting
78
Royal Marsden Hospital (Sutton) ( Site 0741)
London, Surrey, United Kingdom, SM3 5PT
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here