Clinical trial • Phase I/II • Oncology

IFINATAMAB DERUXTECAN for Metastatic castration-resistant prostate cancer

Phase I/II trial of IFINATAMAB DERUXTECAN for Metastatic castration-resistant prostate cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic castration-resistant prostate cancer
Trial Stage
Phase I/II
Drug Modality
ADC|Small molecule

Key dates

Initial CTIS Submission Date
17-03-2025
First CTIS Authorization Date
08-07-2025

Trial design

Randomised, open-label, docetaxel (intravenous infusion) - dose and schedule not specified in the provided record-controlled, adaptive Phase I/II trial across 30 sites in Germany, France, Ireland and others.

Randomised
Yes
Open Label
Yes
Comparator
DOCETAXEL (intravenous infusion) - dose and schedule not specified in the provided record
Adaptive
True, safety lead-in and dose-finding elements to establish an RP2D for combination arms (safety lead-in / dose escalation described in objectives)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
216

Eligibility

Recruits 216 No vulnerable population selected. The trial enrols adult male patients only. Informed consent is obtained from adult participants using country-specific adult consent forms (L1_ICF_Main consent) and associated localized documents; optional addenda (e.g., FBR consent, pregnant partner follow-up, optional procedure consents) are available in some countries. No assent or parental consent procedures for minors are indicated..

Vulnerable Population
No vulnerable population selected. The trial enrols adult male patients only. Informed consent is obtained from adult participants using country-specific adult consent forms (L1_ICF_Main consent) and associated localized documents; optional addenda (e.g., FBR consent, pregnant partner follow-up, optional procedure consents) are available in some countries. No assent or parental consent procedures for minors are indicated.

Inclusion criteria

  • {"criterion_text":"- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n- Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before Screening\n- Has current evidence of metastatic disease\n- Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after treatment\n- 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\n- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 10 days before allocation/randomization\n- 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

  • {"criterion_text":"- Has any history of ILD/pneumonitis irrespective of prior steroid use, current ILD, ILD that cannot be ruled out at screening, or suspected ILD\n- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n- Uncontrolled or significant cardiovascular disease\n- History of pituitary dysfunction\n- Poorly controlled diabetes mellitus\n- History or current condition of adrenal insufficiency (eg, Addison’s disease)\n- Has received prior treatment with taxane-based chemotherapy agent for mCRPC.\n- 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\n- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids\n- Known additional malignancy that is progressing or has required active treatment within the past 3 years\n- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis\n- Active autoimmune disease that has required systemic treatment in the past 2 years\n- History of allogeneic tissue/solid organ transplant"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1.\tEfficacy Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only\n- 2.\tEfficacy Phase: Number of Participants Who Experienced an Adverse Event (AE)\n- 3.\tEfficacy Phase: Number of Participants Who Discontinued Study Intervention Due to an AE\n- 4.\tEfficacy Phase: Prostate-Specific Antigen (PSA) response rate\n- 5.\tSafety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Combination Arms Only\n- 6.\tSafety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE) - Combination Arms Only\n- 7.\tSafety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE - Combination Arms Only","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Efficacy Phase: Objective Response Rate (ORR)","definition_or_measurement_approach":"ORR per PCWG-Modified RECIST 1.1, as assessed by BICR (as specified in secondary objectives)"}
  • {"endpoint_text":"- Efficacy Phase: Radiographic Progression-Free Survival (rPFS)","definition_or_measurement_approach":"rPFS per PCWG-Modified RECIST 1.1, as assessed by BICR"}
  • {"endpoint_text":"- Efficacy Phase: Overall Survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Efficacy Phase: Duration of Response (DOR)","definition_or_measurement_approach":"DOR per PCWG-Modified RECIST 1.1, as assessed by BICR"}
  • {"endpoint_text":"- Efficacy Phase: Time to First Subsequent Anticancer Therapy (TFST)","definition_or_measurement_approach":"Time from randomization/allocation to first subsequent anticancer therapy or death"}
  • {"endpoint_text":"- Efficacy Phase: Time to Prostate-Specific Antigen (PSA) Progression","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Efficacy Phase: Time to Pain Progression (TTPP)","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
216
Recruitment Window Months
53
Consent Approach
Informed consent is obtained from adult participants using country-specific main adult consent forms (L1_ICF_Main consent) and associated localized consent documents. Optional consent addenda are used where applicable (e.g., FBR consent, optional procedures, pregnant partner follow-up). Consent materials are provided in localized languages for participating countries (documents available in English and local languages as per country-specific ICFs). No assent or parental consent for minors is indicated.

Geography

Total Number Of Sites
30
Total Number Of Participants
145

Germany

Earliest CTIS Part Ii Submission Date
18-06-2025
Latest Decision Or Authorization Date
08-07-2025
Processing Time Days
20
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik und Poliklinik für Urologie
Contact Person Name
Marc-Oliver Grimm
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Nationales Centrum für Tumorerkrankungen (NCT) - Klinik f. Medizinische Onkologie
Contact Person Name
Stefanie Zschäbitz
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Department of Internal Medicine II, Oncological Clinical Trials Center
Contact Person Name
Gunhild von Amsberg
Contact Person Email
g.von-amsberg@uke.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Urologie und Kinderurologie
Contact Person Name
Friedemann Zengerling

France

Earliest CTIS Part Ii Submission Date
24-06-2025
Latest Decision Or Authorization Date
08-07-2025
Processing Time Days
14
Number Of Sites
6
Number Of Participants
36

Sites

Site Name
Institut Bergonie
Department Name
Oncologie médicale
Contact Person Name
Guilhem Roubaud
Site Name
Hospices Civils De Lyon
Department Name
Oncologie médicale
Contact Person Name
Denis Maillet
Contact Person Email
denis.maillet@chu-lyon.fr
Site Name
Institut Gustave Roussy
Department Name
Oncologie médicale
Contact Person Name
Natacha Naoun
Contact Person Email
natacha.naoun@gustaveroussy.fr
Site Name
Centre Oscar Lambret
Department Name
Oncologie médicale
Contact Person Name
Yaovi Eric Amela
Contact Person Email
e-amela@o-lambret.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Oncologie médicale
Contact Person Name
Louis François
Contact Person Email
lfrancois@ch-cotebasque.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncologie médicale
Contact Person Name
Emmanuelle Bompas

Ireland

Earliest CTIS Part Ii Submission Date
03-06-2025
Latest Decision Or Authorization Date
11-07-2025
Processing Time Days
38
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
St Vincent's University Hospital
Department Name
Oncology
Contact Person Name
Raymond McDermott
Contact Person Email
ray.mcdermott@ccrt.ie
Site Name
Beaumont Hospital
Department Name
Oncology
Contact Person Name
Yeun Teo
Contact Person Email
Keithegan2@beaumont.ie
Site Name
Tallaght University Hospital
Department Name
Oncology
Contact Person Name
Lynda Corrigan
Contact Person Email
Lynda.corrigan@tuh.ie

Italy

Earliest CTIS Part Ii Submission Date
26-05-2025
Latest Decision Or Authorization Date
08-07-2025
Processing Time Days
43
Number Of Sites
5
Number Of Participants
19

Sites

Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
S.C. Clinical Trial Center e Studi di Fase I ; U.O. Oncologia
Contact Person Name
Alfredo Berruti
Contact Person Email
alfredo.berruti@gmail.com
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
SCDU Oncologia Medica
Contact Person Name
Consuelo Buttigliero
Contact Person Email
consuelo.buttigliero@unito.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Dipartimento Scienze Mediche e Chirurgiche
Contact Person Name
Roberto Iacovelli
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Unità di terapie innovative
Contact Person Name
Roberto Bianco
Contact Person Email
robianco@unina.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Struttura Semplice Dipartimentale Genitourinaria, Dipartimento di Oncologia Medica
Contact Person Name
Elena Verzoni

Poland

Earliest CTIS Part Ii Submission Date
06-06-2025
Latest Decision Or Authorization Date
14-07-2025
Processing Time Days
38
Number Of Sites
4
Number Of Participants
23

Sites

Site Name
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Chemioterapii Jednodniowej
Contact Person Name
Mariusz Kwiatkowski
Contact Person Email
sekretariat.odch@swk.med.pl
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Oddział Kliniczny Onkologii Klinicznej i Doświadczalnej
Contact Person Name
Jacek Mackiewicz
Contact Person Email
badania.ucwbk@ump.edu.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
CWBK UCK Ośrodek Badań Klinicznych Wczesnych Faz
Contact Person Name
Rafal Dziadziuszko
Contact Person Email
obkwf@uck.gda.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Oddzial Badan Wczesnych Faz
Contact Person Name
Iwona Lugowska
Contact Person Email
obwf@nio.gov.pl

Spain

Earliest CTIS Part Ii Submission Date
10-06-2025
Latest Decision Or Authorization Date
09-07-2025
Processing Time Days
29
Number Of Sites
5
Number Of Participants
32

Sites

Site Name
Institut Catala D'oncologia
Department Name
Oncología Médica
Contact Person Name
José María Piulats Rguez
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncología
Contact Person Name
Teresa Alonso Gordoa
Contact Person Email
alonsogordoa@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncología
Contact Person Name
Enrique Gonzalez Billalabeitia
Contact Person Email
egonzalezb@seom.org
Site Name
Hospital Clinico San Carlos
Department Name
Oncología
Contact Person Name
Javier Puente Vázquez
Contact Person Email
javierpuente.hcsc@gmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncología
Contact Person Name
Begoña Pérez Valderrama

Netherlands

Earliest CTIS Part Ii Submission Date
11-06-2025
Latest Decision Or Authorization Date
14-07-2025
Processing Time Days
33
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Department of Medical Oncology
Contact Person Name
Niven Mehra
Contact Person Email
studies.onco@radboudumc.nl
Site Name
Ziekenhuis Gelderse Vallei Stichting
Department Name
Internal Medicine
Contact Person Name
Arnold Baars
Site Name
Ziekenhuis Nij Smellinghe
Department Name
Internal Medicine
Contact Person Name
Grytsje Bouma

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corp.
Responsibilities
Other - EUB services (call center and medical services)
Name
Clario
Responsibilities
code: 7 (responsibility code provided in record)
Name
Almac Clinical Technologies LLC
Responsibilities
code: 3 (responsibility code provided in record)

Third parties

  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Other - EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Roche CDx CAP - CLIA Laboratory","duties_or_roles":"code: 4","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"code: 7","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"code: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Clario","duties_or_roles":"Tumor Imaging and assessment of disease","organisation_type":"Industry"}

Investigational products

Investigational Product Name
Ifinatamab Deruxtecan
Active Substance
IFINATAMAB DERUXTECAN
Modality
ADC
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
1
Investigational Product Name
Opevesostat
Active Substance
OPEVESOSTAT TOSILATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
1
Investigational Product Name
Abiraterone
Active Substance
ABIRATERONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
2
Investigational Product Name
Enzalutamide
Active Substance
ENZALUTAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
2
Investigational Product Name
Prednisolone / Prednisone
Active Substance
PREDNISOLONE / PREDNISONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
2
Combination Treatment
Yes

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