Clinical trial • Phase III • Oncology
IFINATAMAB DERUXTECAN for Metastatic castration-resistant prostate cancer
Phase III 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 III
- Drug Modality
- ADC|Small molecule
Key dates
- Initial CTIS Submission Date
- 19-02-2025
- First CTIS Authorization Date
- 10-06-2025
Trial design
open-label, docetaxel (comparator; product listed with dosing unit mg/m2, product maxdailydoseamount 75 mg/m2; intravenous).-controlled Phase III trial in Austria, Denmark, France and others.
- Open Label
- Yes
- Comparator
- Docetaxel (comparator; product listed with dosing unit mg/m2, product maxDailyDoseAmount 75 mg/m2; intravenous).
- Target Sample Size
- 940
Eligibility
Recruits 940 No vulnerable population selected (isVulnerablePopulationSelected: false). Informed consent will be obtained using country-specific Subject information and informed consent forms (multiple 'L1_ICF_Main consent' documents listed for participating countries). No assent/minor-consent procedures are described in the available documents..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected: false). Informed consent will be obtained using country-specific Subject information and informed consent forms (multiple 'L1_ICF_Main consent' documents listed for participating countries). No assent/minor-consent procedures are described in the available documents.
Inclusion criteria
- {"criterion_text":"- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology"}
- {"criterion_text":"- Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening"}
- {"criterion_text":"- Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI)"}
- {"criterion_text":"- Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment"}
- {"criterion_text":"- Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy"}
- {"criterion_text":"- Has recovered from adverse events (AEs) due to previous anticancer therapies"}
Exclusion criteria
- {"criterion_text":"- Is unable to swallow tablets/capsules"}
- {"criterion_text":"- Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis"}
- {"criterion_text":"- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses"}
- {"criterion_text":"- Has uncontrolled or significant cardiovascular disease"}
- {"criterion_text":"- Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)"}
- {"criterion_text":"- Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities"}
- {"criterion_text":"- Has a “superscan” bone scan"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Overall survival (OS)."}
- {"endpoint_text":"- Radiographic progression-free survival (rPFS)","definition_or_measurement_approach":"Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified RECIST 1.1 as assessed by blinded independent central review (BICR)."}
Secondary endpoints
- {"endpoint_text":"- Time to first subsequent therapy (TFST)","definition_or_measurement_approach":"TFST (time to first subsequent therapy) as specified in secondary objectives."}
- {"endpoint_text":"- Objective response rate (ORR)","definition_or_measurement_approach":"ORR per PCWG Modified RECIST 1.1 as assessed by blinded independent central review (BICR)."}
- {"endpoint_text":"- Duration of Response (DOR)","definition_or_measurement_approach":"Duration of Response (DOR) per PCWG Modified RECIST 1.1 as assessed by BICR."}
- {"endpoint_text":"- Time to pain progression (TTPP)","definition_or_measurement_approach":"TTPP as listed in secondary endpoints (measurement approach not further specified in provided data)."}
- {"endpoint_text":"- Time to prostate-specific antigen (PSA) progression","definition_or_measurement_approach":"Time to PSA progression as listed in secondary endpoints (measurement approach not further specified in provided data)."}
- {"endpoint_text":"- PSA response rate","definition_or_measurement_approach":"PSA response rate as listed in secondary endpoints (definition not further specified in provided data)."}
- {"endpoint_text":"- Time to first symptomatic skeletal-related events (SSRE)","definition_or_measurement_approach":"Time to first SSRE as listed in secondary endpoints (definition not further specified in provided data)."}
- {"endpoint_text":"- Number of Participants Who Experience One or More Adverse Events (AEs)","definition_or_measurement_approach":"Count of participants experiencing one or more AEs (safety endpoint)."}
- {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":"Count of participants discontinuing study treatment due to an AE (safety endpoint)."}
Recruitment
- Planned Sample Size
- 940
- Recruitment Window Months
- 67
- Consent Approach
- Informed consent is obtained using country-specific Subject Information and Informed Consent Forms (multiple 'L1_ICF_Main consent' documents exist for participating countries and languages). Optional consent modules (for example: optional modules such as pregnant partner, optional follow-up modules, Greenphire adults) are provided as separate documents. No assent/minor consent procedures are described.
Geography
- Total Number Of Participants
- 508
Austria
- Earliest CTIS Part Ii Submission Date
- 22-05-2025
- Latest Decision Or Authorization Date
- 11-06-2025
- Processing Time Days
- 20
- Number Of Participants
- 18
Denmark
- Earliest CTIS Part Ii Submission Date
- 26-05-2025
- Latest Decision Or Authorization Date
- 10-06-2025
- Processing Time Days
- 15
- Number Of Participants
- 30
France
- Earliest CTIS Part Ii Submission Date
- 07-04-2025
- Latest Decision Or Authorization Date
- 13-06-2025
- Processing Time Days
- 67
- Number Of Participants
- 70
Ireland
- Earliest CTIS Part Ii Submission Date
- 28-05-2025
- Latest Decision Or Authorization Date
- 13-06-2025
- Processing Time Days
- 16
- Number Of Participants
- 15
Italy
- Earliest CTIS Part Ii Submission Date
- 15-04-2025
- Latest Decision Or Authorization Date
- 13-06-2025
- Processing Time Days
- 59
- Number Of Participants
- 55
Norway
- Earliest CTIS Part Ii Submission Date
- 02-06-2025
- Latest Decision Or Authorization Date
- 12-06-2025
- Processing Time Days
- 10
- Number Of Participants
- 24
Poland
- Earliest CTIS Part Ii Submission Date
- 13-05-2025
- Latest Decision Or Authorization Date
- 16-06-2025
- Processing Time Days
- 34
- Number Of Participants
- 30
Spain
- Earliest CTIS Part Ii Submission Date
- 14-05-2025
- Latest Decision Or Authorization Date
- 13-06-2025
- Processing Time Days
- 30
- Number Of Participants
- 80
Sweden
- Earliest CTIS Part Ii Submission Date
- 15-05-2025
- Latest Decision Or Authorization Date
- 26-08-2025
- Processing Time Days
- 103
- Number Of Participants
- 20
Czechia
- Earliest CTIS Part Ii Submission Date
- 16-04-2025
- Latest Decision Or Authorization Date
- 08-09-2025
- Processing Time Days
- 145
- Number Of Participants
- 30
Netherlands
- Earliest CTIS Part Ii Submission Date
- 16-05-2025
- Latest Decision Or Authorization Date
- 28-08-2025
- Processing Time Days
- 104
- Number Of Participants
- 58
Greece
- Earliest CTIS Part Ii Submission Date
- 18-03-2025
- Latest Decision Or Authorization Date
- 16-06-2025
- Processing Time Days
- 90
- Number Of Participants
- 28
Germany
- Earliest CTIS Part Ii Submission Date
- 23-05-2025
- Latest Decision Or Authorization Date
- 05-12-2025
- Processing Time Days
- 196
- Number Of Participants
- 50
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Eresearchtechnology Inc. (Clario)
- Responsibilities
- Blinded Independent Central Imaging Review; clinical adjudication review of ILD/pneumonitis; contacts: michelle.flores@clario.com, Victoria.Livesey@Clario.com, Prerna.Sharma@clario.com
- Name
- Signant Health LLC
- Responsibilities
- E-source/eCOA/clinical support (sponsorDuties code 3); contact salvador.gomez@signanthealth.com
- Name
- Parexel International Corp.
- Responsibilities
- EUB services (call center and medical services); contact +MSDEMU@parexel.com
- Name
- IQVIA Limited
- Responsibilities
- Operational / site support functions (sponsorDuties code 4); contact morgan.coleman@iqvia.com
Third parties
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes present (e.g. code 7) / contact michelle.flores@clario.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"sponsorDuties code 4 (role stated); contact melissa.young@roche.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health LLC","duties_or_roles":"sponsorDuties code 3 (role stated); contact salvador.gomez@signanthealth.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties value: Blinded Independent Central Imaging Review (clinical adjudication contacts listed); contact Victoria.Livesey@Clario.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties value: Clinical adjudication review of safety events for Interstitial Lung Disease and Pneumonitis; contact Prerna.Sharma@clario.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"sponsorDuties value: EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties code 4 (role stated); contact morgan.coleman@iqvia.com","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ifinatamab Deruxtecan
- Active Substance
- IFINATAMAB DERUXTECAN
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Investigational Product Name
- DOCETAXEL
- Active Substance
- DOCETAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 75 mg/m2 (product maxDailyDoseAmount: 75 mg/m2)
- Investigational Product Name
- PREDNISOLONE / PREDNISONE
- Active Substance
- BETAMETHASONE SODIUM PHOSPHATE / PREDNISOLONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Maximum Dose
- 10 mg (product maxDailyDoseAmount: 10 mg)
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