Actively Recruiting
Phase 1/2 Study of Ifinatamab Deruxtecan Alone or with Other Treatments for Metastatic Castration-Resistant Prostate Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-29
360
Participants Needed
80
Research Sites
N/A
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
Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd), alone or combined with other treatments, for people with metastatic castration-resistant prostate cancer (mCRPC). This study aims to find a safe dose of I-DXd in combination with other therapies and to monitor prostate specific antigen (PSA) levels during treatment. It is a phase 1/2, open-label study under the MK-2400-U01 master protocol. Participants may receive one of several treatments: docetaxel given intravenously every three weeks for up to 10 cycles; I-DXd alone administered intravenously every three weeks until side effects, disease progression, death, or withdrawal; I-DXd combined with MK-5684 taken orally; or I-DXd combined with an androgen receptor pathway inhibitor (either abiraterone acetate or enzalutamide) taken orally. The study includes a dose escalation phase followed by longer treatment periods. During the study, participants will be monitored for treatment side effects, PSA response, and other outcomes such as disease progression and survival over several years. Researchers will track adverse events, dose-limiting toxicities, and reasons for stopping treatment. The total follow-up may last up to about 54 months, with regular assessments including safety, efficacy, and quality of life measures.
CONDITIONS
Brief 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 adenocarcinoma of the prostate without small cell histology
- Evidence of metastatic prostate cancer progression during androgen deprivation therapy within 6 months before screening
- Current metastatic disease
- Prior treatment with 1 or 2 androgen receptor pathway inhibitors with progression during or after treatment
- Stable bone resorptive therapy for 4 or more weeks before randomization if applicable
- 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 ineligible for such treatment
You will not qualify if you...
- History of interstitial lung disease or pneumonitis requiring steroids, or current or 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 (e.g., Addison's disease)
- Prior treatment with taxane-based chemotherapy for mCRPC
- Chronic steroid use over 10 mg daily prednisone equivalent except for certain inhaled or topical steroids
- Radiotherapy within 2 weeks before study start or radiation-related toxicities requiring corticosteroids
- Active malignancy requiring treatment within past 3 years
- Active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Varies by treatment; up to several months depending on cycles or until discontinuation criteria are met
Participants receive assigned drug treatments including docetaxel every 3 weeks for up to 10 cycles, or Ifinatamab Deruxtecan alone or combined with MK-5684 or androgen receptor pathway inhibitors until unacceptable toxicity, disease progression, death, or withdrawal.
Visits every 3 weeks corresponding with treatment cycles
Trial Site Locations
Total: 80 locations
1
UCLA Hematology & Oncology ( Site 0003)
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of California-Irvine Medical Center ( Site 0016)
Orange, California, United States, 92868
Actively Recruiting
3
UCSF Medical Center at Mission Bay ( Site 0034)
San Francisco, California, United States, 94158
Actively Recruiting
4
MedStar Georgetown Cancer Institute at MedStar Washington Hospital Center ( Site 0026)
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center ( Site 0006)
New York, New York, United States, 10065
Actively Recruiting
6
UPMC Hillman Cancer Center ( Site 0014)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
7
The West Clinic, PLLC dba West Cancer Center ( Site 0005)
Germantown, Tennessee, United States, 38138
Actively Recruiting
8
Fred Hutchinson Cancer Center ( Site 0013)
Seattle, Washington, United States, 98109
Actively Recruiting
9
Instituto Alexander Fleming ( Site 0202)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
Actively Recruiting
10
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0200)
La Rioja, Argentina, F5300COE
Actively Recruiting
11
Macquarie University-MQ Health Clinical Trials Unit ( Site 0801)
Macquarie University, New South Wales, Australia, 2109
Actively Recruiting
12
Liga Norte Riograndense Contra o Câncer ( Site 0271)
Natal, Rio Grande do Norte, Brazil, 59062-000
Actively Recruiting
13
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0270)
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Actively Recruiting
14
Hospital Moinhos de Vento ( Site 0278)
Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
Actively Recruiting
15
Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0268)
Bragança Paulista, São Paulo, Brazil, 12916-542
Actively Recruiting
16
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
17
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
18
Hospital Alemao Oswaldo Cruz ( Site 0279)
São Paulo, São Paulo, Brazil, 01327-001
Actively Recruiting
19
IPITEC ( Site 0275)
São Paulo, Brazil, 01221-020
Actively Recruiting
20
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0269)
São Paulo, Brazil, 03102-006
Actively Recruiting
21
BC Cancer - Vancouver Center ( Site 0103)
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
22
Sunnybrook Research Institute ( Site 0109)
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
23
Princess Margaret Cancer Centre ( Site 0102)
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
24
Jewish General Hospital ( Site 0108)
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
25
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0107)
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
26
Clinica Universidad Catolica del Maule ( Site 0236)
Talca, Maule Region, Chile, 3465584
Actively Recruiting
27
FALP ( Site 0232)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
28
Centro de Oncología de Precisión ( Site 0241)
Santiago, Region M. de Santiago, Chile, 7560908
Actively Recruiting
29
Bradfordhill ( Site 0231)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
30
ONCOCENTRO APYS ( Site 0234)
Viña del Mar, Valparaiso, Chile, 2520598
Actively Recruiting
31
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0498)
Bordeaux, Gironde, France, 33000
Actively Recruiting
32
Centre Oscar Lambret ( Site 0495)
Lille, Nord, France, 59000
Actively Recruiting
33
Institut De Cancerologie De L Ouest ( Site 0494)
Saint-Herblain, Pays de la Loire Region, France, 44800
Actively Recruiting
34
Centre Hospitalier de la Côte Basque ( Site 0496)
Bayonne, Pyrenees-Atlantiques, France, 64100
Actively Recruiting
35
centre hospitalier lyon sud ( Site 0497)
Pierre-Bénite, Rhone, France, 69310
Actively Recruiting
36
NCT ( Site 0528)
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
37
Universitaetsklinikum Jena ( Site 0525)
Jena, Thuringia, Germany, 07747
Actively Recruiting
38
Universitaetsklinikum Hamburg-Eppendorf ( Site 0524)
Hamburg, Germany, 20246
Actively Recruiting
39
St Vincent's University Hospital ( Site 0463)
Dublin, Dublin, Ireland, D04 T6F4
Actively Recruiting
40
Beaumont Hospital, Dublin ( Site 0465)
Dublin, Ireland, D09 V2N0
Actively Recruiting
41
Tallaght University Hospital ( Site 0462)
Dublin, Ireland, D24 NR0A
Actively Recruiting
42
Rambam Health Care Campus ( Site 0400)
Haifa, Israel, 3109601
Actively Recruiting
43
Hadassah Medical Center ( Site 0404)
Jerusalem, Israel, 9112001
Actively Recruiting
44
Rabin Medical Center ( Site 0402)
Petah Tikva, Israel, 4941492
Actively Recruiting
45
Sheba Medical Center ( Site 0401)
Ramat Gan, Israel, 5265601
Actively Recruiting
46
Sourasky Medical Center ( Site 0403)
Tel Aviv, Israel, 6423906
Actively Recruiting
47
AOU San Luigi Gonzaga di Orbassano ( Site 0434)
Orbassano, Torino, Italy, 10143
Actively Recruiting
48
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 0432)
Brescia, Italy, 25123
Actively Recruiting
49
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0431)
Milan, Italy, 20133
Actively Recruiting
50
A.O.U. Federico II di Napoli ( Site 0435)
Naples, Italy, 80131
Actively Recruiting
51
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0433)
Roma, Italy, 00168
Actively Recruiting
52
Ziekenhuis Gelderse Vallei ( Site 0683)
Ede, Gelderland, Netherlands, 6716 RP
Actively Recruiting
53
UMC St. Radboud ( Site 0679)
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
54
Nij Smellinghe ( Site 0684)
Drachten, Provincie Friesland, Netherlands, 9202 NN
Actively Recruiting
55
Auckland City Hospital ( Site 0831)
Auckland, New Zealand, 1023
Actively Recruiting
56
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 0590)
Poznan, Greater Poland Voivodeship, Poland, 60-355
Actively Recruiting
57
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0586)
Warsaw, Masovian Voivodeship, Poland, 02-781
Actively Recruiting
58
Uniwersyteckie Centrum Kliniczne ( Site 0588)
Gdansk, Pomeranian Voivodeship, Poland, 80-214
Actively Recruiting
59
Szpital Wojewódzki im. M.Kopernika Oddział Onk. Klinicznej z Pododdziałem Chemioterapii Jednodniowej ( Site 0587)
Koszalin, West Pomeranian Voivodeship, Poland, 75-581
Actively Recruiting
60
Asan Medical Center ( Site 0925)
Songpagu, Seoul, South Korea, 05505
Actively Recruiting
61
Severance Hospital Yonsei University Health System ( Site 0924)
Seoul, South Korea, 03722
Active, Not Recruiting
62
Samsung Medical Center ( Site 0926)
Seoul, South Korea, 06351
Actively Recruiting
63
ICO L Hospitalet ( Site 0617)
L Hospitalet Del Llobregat, Barcelona, Spain, 08908
Actively Recruiting
64
Hospital Universitario Ramon y Cajal ( Site 0620)
Madrid, Spain, 28034
Actively Recruiting
65
Hospital Clinico San Carlos ( Site 0618)
Madrid, Spain, 28040
Actively Recruiting
66
Hospital Universitario 12 de Octubre ( Site 0622)
Madrid, Spain, 28041
Actively Recruiting
67
Hospital Universitario Virgen del Rocio ( Site 0619)
Seville, Spain, 41013
Actively Recruiting
68
Taichung Veterans General Hospital ( Site 0902)
Taichung, Taiwan, 40705
Actively Recruiting
69
Taipei Veterans General Hospital ( Site 0901)
Taipei, Taiwan, 11217
Actively Recruiting
70
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0650)
Adana, Turkey (Türkiye), 01250
Actively Recruiting
71
Hacettepe Universitesi Tip Fakultesi ( Site 0648)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
72
Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0653)
Ankara, Turkey (Türkiye), 06620
Actively Recruiting
73
Ankara Bilkent Şehir Hastanesi ( Site 0654)
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
74
Koç Üniversitesi Hastanesi ( Site 0656)
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
75
Istanbul Universitesi Cerrahpasa ( Site 0649)
Istanbul, Turkey (Türkiye), 34098
Actively Recruiting
76
Recep Tayyip Erdogan University Training and Research Hospital ( Site 0655)
Rize, Turkey (Türkiye), 53020
Actively Recruiting
77
Addenbrooke's Hospital ( Site 0747)
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Actively Recruiting
78
St Bartholomew's Hospital ( Site 0749)
London, London, City of, United Kingdom, EC1A 7BE
Actively Recruiting
79
Royal Free Hospital ( Site 0743)
London, London, City of, United Kingdom, NW3 2QG
Actively Recruiting
80
Royal Marsden Hospital (Sutton) ( Site 0741)
London, Surrey, United Kingdom, SM3 5PT
Actively Recruiting
Research Team
T
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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