Clinical trial • Phase II • Oncology

LUXDEGALUTAMIDE for Metastatic hormone-sensitive prostate cancer

Phase II trial of LUXDEGALUTAMIDE for Metastatic hormone-sensitive prostate cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Metastatic hormone-sensitive prostate cancer
Trial Stage
Phase II
Drug Modality
Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
09-05-2025
First CTIS Authorization Date
19-08-2025

Trial design

Randomised, open-label, comparator arms include abiraterone (oral tablet; dose not specified in dataset) and enzalutamide (oral; dose not specified in dataset).-controlled, adaptive Phase II trial in Netherlands, Czechia, Germany and others.

Randomised
Yes
Open Label
Yes
Comparator
Comparator arms include Abiraterone (oral tablet; dose not specified in dataset) and Enzalutamide (oral; dose not specified in dataset).
Adaptive
True, dose selection/adaptive element: determination of JSB462 dose (100 mg QD vs 300 mg QD) based on integrated assessment of efficacy, safety and tolerability; protocol allows pooling or selection of the best of the two doses for comparison versus control.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
87

Eligibility

Recruits 87 No vulnerable populations selected. Study population is adult male patients only. Informed consent is required from each adult participant. Separate information sheets exist for female partners (e.g. 'Info Sheet Female Partner') and follow-up for pregnant partners are provided in the documentation, indicating partner-specific information but the trial does not include minors or other vulnerable groups and consent/assent for such groups is not applicable..

Vulnerable Population
No vulnerable populations selected. Study population is adult male patients only. Informed consent is required from each adult participant. Separate information sheets exist for female partners (e.g. 'Info Sheet Female Partner') and follow-up for pregnant partners are provided in the documentation, indicating partner-specific information but the trial does not include minors or other vulnerable groups and consent/assent for such groups is not applicable.

Inclusion criteria

  • {"criterion_text":"- An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤2\n- Histologically confirmed adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible\n- High-volume mHSPC, defined by the presence of ≥1 metastatic visceral non-nodal lesion and/or ≥4 metastatic bone lesions (with at least one lesion outside the vertebral column and/or pelvis) in imaging exams (CT/MRI or bone scan) according to local radiology assessment by the investigator obtained ≤28 days prior to randomization\n- Participants must have a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L). Ongoing ADT (as defined by prior orchiectomy and/or ongoing GnRH analog/antagonist) for ≤90 days is allowed prior to randomization, provided that PSA zero (PSA level <0.2 ng/ml according to local laboratory as assessed by the investigator) is not achieved prior to randomization."}

Exclusion criteria

  • {"criterion_text":"- Prior exposure to a second generation ARPI (such as enzalutamide/darolutamide/apalutamide and/or abiraterone) for the treatment of advanced/metastatic disease is not allowed. Prior exposure to an ARPI, to taxane chemotherapy (up to 6 cycles) or to RLT in the context of (neo)adjuvant treatment for localized prostate cancer is allowed, if the last dose of this treatment was administered >12 months from randomization. Prior use of a first generation ARPI (such as bicalutamide) in the context of ADT initiation with a GnRH analog is allowed, provided the first generation ARPI was administered for ≤14 days and last dose was administered ≥7 days from randomization\n- Participants with biochemical recurrence only or those without evidence of metastatic disease by radiological imaging (CT/MRI or bone scan) are not eligible"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PSA90 rate defined as the proportion of participants who achieve a ≥90% decrease in PSA from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between.","definition_or_measurement_approach":"Proportion of participants achieving ≥90% decrease in PSA from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks later with no PSA progression between measurements."}
  • {"endpoint_text":"- Type, frequency and severity of AEs per CTCAE version 5.0 and changes in laboratory values, vital signs, and ECGs","definition_or_measurement_approach":"Adverse events graded using CTCAE v5.0; changes in laboratory values, vital signs and ECGs as recorded and graded per protocol."}
  • {"endpoint_text":"- Tolerability: dose interruptions, dose reductions, drug discontinuations, dose intensity, and duration of exposure to study treatment (all study drugs)","definition_or_measurement_approach":"Assessment of tolerability by recording dose interruptions, dose reductions, drug discontinuations, dose intensity and duration of exposure for all study treatments."}

Secondary endpoints

  • {"endpoint_text":"- rPFS defined as time between randomization and the first occurrence of disease progression (per PCWG3-modified RECIST 1.1 as assessed by the investigator) or death due to any cause","definition_or_measurement_approach":"Time from randomization to first documented disease progression per PCWG3-modified RECIST 1.1 (investigator-assessed) or death from any cause."}
  • {"endpoint_text":"- OS defined as time between randomization and death due to any cause","definition_or_measurement_approach":"Time from randomization to death due to any cause."}
  • {"endpoint_text":"- Type, frequency and severity of xxxx AEs and changes in laboratory values (xxxx) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0)","definition_or_measurement_approach":"Adverse events characterized by type, frequency and severity graded per NCI CTCAE v5.0; laboratory value changes characterized similarly (text contains placeholders 'xxxx')."}
  • {"endpoint_text":"- ORR defined as proportion of participants achieving a confirmed complete response (CR) or partial response (PR) per PCWG3-modified RECIST 1.1 as assessed by the investigator","definition_or_measurement_approach":"Proportion achieving confirmed CR or PR per PCWG3-modified RECIST 1.1 (investigator-assessed)."}
  • {"endpoint_text":"- DCR defined as proportion of participants achieving a CR, PR or stable disease (SD) per PCWG3-modified RECIST 1.1 as assessed by the investigator","definition_or_measurement_approach":"Proportion achieving CR, PR or SD per PCWG3-modified RECIST 1.1 (investigator-assessed)."}
  • {"endpoint_text":"- DOR defined as time between first documented CR/PR and disease progression or death due to any cause per PCWG3-modified RECIST 1.1 as assessed by the investigator","definition_or_measurement_approach":"Time from first documented CR/PR to disease progression or death per PCWG3-modified RECIST 1.1 (investigator-assessed)."}
  • {"endpoint_text":"- TTR defined as the time from randomization to the date of first documented CR or PR per PCWG3-modified RECIST 1.1 as assessed by the investigator","definition_or_measurement_approach":"Time from randomization to first documented CR or PR per PCWG3-modified RECIST 1.1 (investigator-assessed)."}
  • {"endpoint_text":"- TTSTP defined as time from randomization to the date of first documented radiographic soft tissue progression per PCWG3-modified RECIST 1.1 as assessed by the investigator","definition_or_measurement_approach":"Time from randomization to first documented radiographic soft tissue progression per PCWG3-modified RECIST 1.1 (investigator-assessed)."}
  • {"endpoint_text":"- PSA30 rate defined as the proportion of participants who achieve a ≥30% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between","definition_or_measurement_approach":"Proportion achieving ≥30% decrease in PSA from baseline at any time, confirmed by a second PSA measurement ≥3 weeks later with no PSA progression between."}
  • {"endpoint_text":"- PSA50 rate defined as the proportion of participants who achieve a ≥50% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between","definition_or_measurement_approach":"Proportion achieving ≥50% decrease in PSA from baseline at any time, confirmed by a second PSA measurement ≥3 weeks later with no PSA progression between."}
  • {"endpoint_text":"- PSA0, defined as the proportion of participants who achieve a PSA level <0.2 ng/ml at any timepoint after start of treatment, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between","definition_or_measurement_approach":"Proportion achieving PSA <0.2 ng/ml at any time after treatment start, confirmed by a second PSA measurement ≥3 weeks later with no PSA progression between."}
  • {"endpoint_text":"- Duration of biochemical response defined as time between PSA90 and/or PSA0 and PSA progression (increase ≥25% in PSA and an absolute increase of ≥2 ng/mL from NADIR) or death due to any cause","definition_or_measurement_approach":"Time from PSA90 and/or PSA0 to PSA progression (≥25% increase and absolute increase ≥2 ng/mL from nadir) or death."}
  • {"endpoint_text":"- TTSSE defined as date of randomization to the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain or death from any cause, whichever occurs first","definition_or_measurement_approach":"Time from randomization to first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgery, need for radiation to relieve bone pain, or death, whichever occurs first."}
  • {"endpoint_text":"- Plasma concentrations of JSB462 and ARV-767 pre and post dose","definition_or_measurement_approach":"Measurement of plasma concentrations of JSB462 and metabolite ARV-767 before and after dosing."}
  • {"endpoint_text":"- Frequency, severity, and/or interference of selected items as assessed using the PRO-CTCAE","definition_or_measurement_approach":"Assessment of selected patient-reported items using PRO-CTCAE capturing frequency, severity and interference."}

Recruitment

Planned Sample Size
87
Recruitment Window Months
77
Consent Approach
Informed consent is required from each adult participant (adult male patients). Main informed consent forms (Main ICF - Adult) are provided in multiple languages (English, Dutch, Czech, Spanish, Polish, French, Italian, German as per submitted documents). Additional information sheets exist for female partners and for follow-up of pregnant partners; optional assessment consent documents are also provided. Consent is obtained from the participant; no assent processes for minors are applicable because minors are not included.

Geography

Total Number Of Sites
32
Total Number Of Participants
63

Netherlands

Earliest CTIS Part Ii Submission Date
07-08-2025
Latest Decision Or Authorization Date
19-08-2025
Processing Time Days
12
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Sint Franciscus Vlietland Groep Stichting
Department Name
#2203: oncology
Principal Investigator Name
Paul Hamberg
Principal Investigator Email
p.hamberg@franciscus.nl
Contact Person Name
Paul Hamberg
Contact Person Email
p.hamberg@franciscus.nl
Site Name
Spaarne Gasthuis Stichting
Department Name
#2200 : oncology
Principal Investigator Name
Aart Beeker
Principal Investigator Email
abeeker@spaarnegasthuis.nl
Contact Person Name
Aart Beeker
Contact Person Email
abeeker@spaarnegasthuis.nl
Site Name
Isala Klinieken Stichting
Department Name
#2202: oncology
Principal Investigator Name
Metin Tascilar
Principal Investigator Email
m.tascilar@isala.nl
Contact Person Name
Metin Tascilar
Contact Person Email
m.tascilar@isala.nl
Site Name
Albert Schweitzer Ziekenhuis
Department Name
#2201: oncology
Principal Investigator Name
Joan van den Bosch
Principal Investigator Email
j.vandenbosch@asz.nl
Contact Person Name
Joan van den Bosch
Contact Person Email
j.vandenbosch@asz.nl

Czechia

Earliest CTIS Part Ii Submission Date
25-07-2025
Latest Decision Or Authorization Date
20-10-2025
Processing Time Days
87
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
1601:Urologicka klinika
Principal Investigator Name
Stepan Vesely
Principal Investigator Email
stepan.vesely@fnmotol.cz
Contact Person Name
Stepan Vesely
Contact Person Email
stepan.vesely@fnmotol.cz
Site Name
Masarykuv Onkologicky Ustav
Department Name
1602:Onkologicka klinika
Principal Investigator Name
Stanislav Spelda
Principal Investigator Email
stanislav.spelda@mou.cz
Contact Person Name
Stanislav Spelda
Contact Person Email
stanislav.spelda@mou.cz
Site Name
University Hospital Olomouc
Department Name
1600:Onkologicka klinika
Principal Investigator Name
Hana Studentova
Principal Investigator Email
hana.studentova@fnol.cz
Contact Person Name
Hana Studentova
Contact Person Email
hana.studentova@fnol.cz

Germany

Earliest CTIS Part Ii Submission Date
28-05-2025
Latest Decision Or Authorization Date
20-08-2025
Processing Time Days
84
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
University Medical Center Hamburg-Eppendorf
Department Name
#1801: Zentrum für Onkologie
Principal Investigator Name
Gunhild von Amsberg
Principal Investigator Email
g.von-amsberg@uke.de
Contact Person Name
Gunhild von Amsberg
Contact Person Email
g.von-amsberg@uke.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
#1800: Klinik für Urologie
Principal Investigator Name
Axel Merseburger
Principal Investigator Email
Axel.Merseburger@uksh.de
Contact Person Name
Axel Merseburger
Contact Person Email
Axel.Merseburger@uksh.de
Site Name
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Department Name
#1802: Studienpraxis Urologie
Principal Investigator Name
Tilman Todenhoefer
Principal Investigator Email
todenhoefer@studienurologie.de
Contact Person Name
Tilman Todenhoefer
Contact Person Email
todenhoefer@studienurologie.de
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
#1804: Klinik für Urologie
Principal Investigator Name
Marc Rehlinghaus
Principal Investigator Email
marc.rehlinghaus@med.uni-duesseldorf.de
Contact Person Name
Marc Rehlinghaus

Italy

Earliest CTIS Part Ii Submission Date
28-05-2025
Latest Decision Or Authorization Date
19-08-2025
Processing Time Days
83
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
#2001: U.O.C. Oncologia Medica
Principal Investigator Name
Andrea Zivi
Principal Investigator Email
andrea.zivi@aovr.veneto.it
Contact Person Name
Andrea Zivi
Contact Person Email
andrea.zivi@aovr.veneto.it
Site Name
Ospedale Cardinal Massaia
Department Name
#2004: S.O.C. Oncologia
Principal Investigator Name
Marcello Tucci
Principal Investigator Email
mtucci@asl.at.it
Contact Person Name
Marcello Tucci
Contact Person Email
mtucci@asl.at.it
Site Name
Azienda Provinciale Per I Servizi Sanitari
Department Name
#2003: U.O. di Oncologia Medica
Principal Investigator Name
Orazio Caffo
Principal Investigator Email
orazio.caffo@apss.tn.it
Contact Person Name
Orazio Caffo
Contact Person Email
orazio.caffo@apss.tn.it
Site Name
Istituto Oncologico Veneto
Department Name
#2000: Oncologia Medica 1
Principal Investigator Name
Umberto Basso
Principal Investigator Email
umberto.basso@iov.veneto.it
Contact Person Name
Umberto Basso
Contact Person Email
umberto.basso@iov.veneto.it
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
#2005: S.C.D.U. Oncologia Medica
Principal Investigator Name
Consuelo Buttigliero
Principal Investigator Email
consuelo.buttigliero@unito.it
Contact Person Name
Consuelo Buttigliero
Contact Person Email
consuelo.buttigliero@unito.it

Poland

Earliest CTIS Part Ii Submission Date
12-08-2025
Latest Decision Or Authorization Date
01-09-2025
Processing Time Days
20
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Aidport Sp. z o.o.
Department Name
#2303 : Onkologia Kliniczna
Principal Investigator Name
Piotr Tomczak
Principal Investigator Email
md.piotr.tomczak@gmail.com
Contact Person Name
Piotr Tomczak
Contact Person Email
md.piotr.tomczak@gmail.com
Site Name
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Department Name
#2300: Klinika Onkologi Klinicznej
Principal Investigator Name
Dariusz Kucharczyk
Principal Investigator Email
badania.kliniczne@onkol.kielce.pl
Contact Person Name
Dariusz Kucharczyk
Site Name
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Department Name
#2301: Klinika Onkologii i Immunoonkologii z Oddziałem Dziennym Terapii Onkologicznej
Principal Investigator Name
Dawid Sigorski
Principal Investigator Email
dawidsigorski@wp.pl
Contact Person Name
Dawid Sigorski
Contact Person Email
dawidsigorski@wp.pl
Site Name
Formed 2 Sp. z o.o.
Department Name
#2302 : Onkologia Kliniczna
Principal Investigator Name
Marcin Kowalski
Principal Investigator Email
marcin.kowalski@nzozformed2.pl
Contact Person Name
Marcin Kowalski
Contact Person Email
marcin.kowalski@nzozformed2.pl

Spain

Earliest CTIS Part Ii Submission Date
14-08-2025
Latest Decision Or Authorization Date
22-08-2025
Processing Time Days
8
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Hospital Universitario Lucus Augusti
Department Name
2502:Oncología
Principal Investigator Name
Sergio Vazquez Estevez
Principal Investigator Email
sergio.vazquez.estevez@sergas.es
Contact Person Name
Sergio Vazquez Estevez
Site Name
Hospital Universitario De Badajoz
Department Name
2505:Oncología
Principal Investigator Name
Marta Gonzalez Cordero
Principal Investigator Email
marta.gonzalezc@salud-juntaex.es
Contact Person Name
Marta Gonzalez Cordero
Site Name
Hospital Universitario Reina Sofia
Department Name
2501:Oncología
Principal Investigator Name
Maria Jose Mendez Vidal
Principal Investigator Email
mj.mendez.sspa@juntadeandalucia.es
Contact Person Name
Maria Jose Mendez Vidal
Site Name
Clinica Universidad De Navarra
Department Name
2500:Oncología
Principal Investigator Name
Nuria Lainez Milagro
Principal Investigator Email
nuria.lainez.milagro@navarra.es
Contact Person Name
Nuria Lainez Milagro
Site Name
Hospital Clinic De Barcelona
Department Name
2503:Oncología
Principal Investigator Name
Begoña Mellado Gonzalez
Principal Investigator Email
bmellado@clinic.cat
Contact Person Name
Begoña Mellado Gonzalez
Contact Person Email
bmellado@clinic.cat
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
2504:Oncología
Principal Investigator Name
Ignacio Jose Duran Martinez
Principal Investigator Email
ignaciojose.duran@scsalud.es
Contact Person Name
Ignacio Jose Duran Martinez
Contact Person Email
ignaciojose.duran@scsalud.es

France

Earliest CTIS Part Ii Submission Date
12-08-2025
Latest Decision Or Authorization Date
19-11-2025
Processing Time Days
99
Number Of Sites
6
Number Of Participants
9

Sites

Site Name
Centre Antoine Lacassagne
Department Name
1700:Medical Oncology
Principal Investigator Name
Delphine BORCHIELLINI
Principal Investigator Email
Delphine.borchiellini@nice.unicancer.fr
Contact Person Name
Delphine BORCHIELLINI
Site Name
Capio La Croix Du Sud
Department Name
1701:Urology
Principal Investigator Name
Guillaume PLOUSSARD
Principal Investigator Email
dr.gploussard@gmail.com
Contact Person Name
Guillaume PLOUSSARD
Contact Person Email
dr.gploussard@gmail.com
Site Name
Assistance Publique Hopitaux De Paris
Department Name
1702: Medical Oncology
Principal Investigator Name
Stephane OUDARD
Principal Investigator Email
Stephane.oudard@aphp.fr
Contact Person Name
Stephane OUDARD
Contact Person Email
Stephane.oudard@aphp.fr
Site Name
Institut Mutualiste Montsouris
Department Name
1704:Urology
Principal Investigator Name
Eric BARRET
Principal Investigator Email
eric.barret@imm.fr
Contact Person Name
Eric BARRET
Contact Person Email
eric.barret@imm.fr
Site Name
Institut Paoli Calmettes
Department Name
1703:Medical Oncology
Principal Investigator Name
Gwenaelle GRAVIS
Principal Investigator Email
gravisg@ipc.unicancer.fr
Contact Person Name
Gwenaelle GRAVIS
Contact Person Email
gravisg@ipc.unicancer.fr
Site Name
Hospital Foch
Department Name
1705:Medical Oncology
Principal Investigator Name
Raffaele RATTA
Principal Investigator Email
r.ratta@hopital-foch.com
Contact Person Name
Raffaele RATTA
Contact Person Email
r.ratta@hopital-foch.com

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA Limited
Responsibilities
CTIS contact and operational support (sponsorDuties codes provided: 3 and 1); contact eu_clinical_trials_information@iqvia.com
Name
Parexel International (IRL) Limited
Responsibilities
Responsibilities indicated by sponsorDuties code 12; contact Clinicaltrial.Enquiries@parexel.com
Name
Syneos Health Inc.
Responsibilities
Responsibilities indicated by sponsorDuties code 1; contact sm_ctis@syneoshealth.com
Name
Icon Clinical Research Limited
Responsibilities
Responsibilities indicated by sponsorDuties code 1; contact Triona.PriceSmith1@docsglobal.com
Name
Veeda Clinical Research Limited
Responsibilities
Responsibilities indicated by sponsorDuties code 4; contact info@veedacr.com

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [3] ; contact eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Veeda Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [4] ; contact info@veedacr.com","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: [12] ; contact Clinicaltrial.Enquiries@parexel.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: [1] ; contact sm_ctis@syneoshealth.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties: [15] Image collection and QC; contact support@bioclinica.com","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"sponsorDuties codes: [4] ; contact CTISApplications-Pharma@iconplc.com","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [6,7] ; contact info@medidata.com","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1] ; contact Triona.PriceSmith1@docsglobal.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: [1] ; contact eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Jumo Health USA Inc.","duties_or_roles":"sponsorDuties: [15] Patients guides and tools; contact hello@jumohealth.com","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"France","full_name":"Kayentis","duties_or_roles":"sponsorDuties: [15] PRO management, translations, data collection via tablet; contact projectmanagement@kayentis.com","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Luxdegalutamide (JSB462)
Active Substance
LUXDEGALUTAMIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
1
Starting Dose
100 mg QD
Dose Levels
100 mg QD | 300 mg QD
Frequency
QD
Maximum Dose
300 mg (maxDailyDoseAmount)
Dose Escalation Increase
100 mg -> 300 mg
Investigational Product Name
Abiraterone
Active Substance
ABIRATERONE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
1
Maximum Dose
1000 mg (maxDailyDoseAmount)
Investigational Product Name
Enzalutamide
Active Substance
ENZALUTAMIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
1
Maximum Dose
160 mg (maxDailyDoseAmount)
Investigational Product Name
RELUGOLIX
Active Substance
RELUGOLIX
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
2
Maximum Dose
360 mg (maxDailyDoseAmount)
Investigational Product Name
DEGARELIX
Active Substance
DEGARELIX
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENOUS INJECTION
Route
INTRAVENOUS INJECTION
Authorisation Status
2
Maximum Dose
240 mg (maxDailyDoseAmount)
Combination Treatment
Yes

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