A Study of JNJ-101556143 in Participants With Metastatic Prostate Cancer
A Phase 2, Open-label, Multicenter, Single-arm Trial of JNJ-101556143, an Androgen Receptor-targeted Regulated Induced Proximity Targeting Chimera (RIPTAC™) Therapeutic in Participants With Metastatic Androgen Pathway Modulation-Resistant Prostate Cancer
The purpose of this study is to evaluate how well JNJ-101556143 works in participants with metastatic androgen pathway modulation-resistant prostate cancer (mAPMR), an advanced form of prostate cancer that has spread and no longer responds to hormone therapy. The study will measure the overall response (tumor shrinkage or disappearance) following treatment with JNJ-101556143.
Przegląd badań
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 2
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Study Contact
- Numer telefonu: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Lokalizacje studiów
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Chermside, Australia, 4032
- Rekrutacyjny
- Icon Ctr Chermside
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East Melbourne, Australia, 3002
- Rekrutacyjny
- Epworth Healthcare
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Hobart, Australia, 7000
- Rekrutacyjny
- Icon Cancer Ctr Hobart
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Kurralta Park, Australia, 5037
- Rekrutacyjny
- Icon Cancer Centre Kurralta Park
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Guangzhou, Chiny, 510060
- Rekrutacyjny
- Sun Yat Sen University Cancer Center
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Wenzhou, Chiny, 325000
- Rekrutacyjny
- The First Affiliated Hospital of Wenzhou Medical University
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Kobe, Japonia, 650 0017
- Rekrutacyjny
- Kobe University Hospital
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Florida
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Largo, Florida, Stany Zjednoczone, 33771
- Rekrutacyjny
- Advanced Urology Institute
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Illinois
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Chicago Ridge, Illinois, Stany Zjednoczone, 60415
- Rekrutacyjny
- Associated Urological Specialists
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Indiana
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Carmel, Indiana, Stany Zjednoczone, 46032
- Rekrutacyjny
- Urology of Indiana
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Louisiana
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Lafayette, Louisiana, Stany Zjednoczone, 70508
- Rekrutacyjny
- Southern Urology LLC
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Massachusetts
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Plymouth, Massachusetts, Stany Zjednoczone, 02360
- Rekrutacyjny
- Greater Boston Urology
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New York
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Syracuse, New York, Stany Zjednoczone, 13210
- Rekrutacyjny
- Associated Medical Professionals
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Tennessee
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Germantown, Tennessee, Stany Zjednoczone, 38138
- Rekrutacyjny
- The Conrad Pearson Clinic
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Have histologically confirmed adenocarcinoma of the prostate. Primary (or pathologic evidence of conversion to) small cell carcinoma, carcinoid tumor, mixed neuroendocrine carcinoma, large cell neuroendocrine carcinoma, or sarcoma of the prostate is disallowed
- Progressive metastatic androgen pathway modulation-resistant prostate cancer (mAPMR) defined as having a Prostate-Specific Antigen (PSA) level greater than or equal (>=) 10 nanograms per milliliter (ng/mL) and at least one of the following: (a) PSA progression defined as at least 2 consecutive increases in PSA value over a previous reference value measured at least 1 week apart. (b) Progressive disease or new lesion(s) in the lymph nodes, bones, or viscera on conventional imaging (computed tomography [CT]/magnetic resonance imaging [MRI]) as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) and/or on bone scan per Prostate Cancer Working Group 4 (PCWG4) while on Androgen Deprivation Therapy (ADT) (either surgically [bilateral orchiectomy] or with medication). Local-regional disease including invasive disease of rectum, bladder, pelvis is allowed as long as participant has a current or past history of distant metastasis (M1 disease). Participants in Part 1 must have measurable disease per RECIST v1.1 by conventional imaging with CT or MRI (chest, abdomen, and pelvis) and/or Technetium-99^m (99^mTc) bone scan confirmed by Blinded Independent Central Review (BICR) at the time of screening
- Prior bilateral orchiectomy or medical castration (receiving ongoing ADT with a Gonadotropin-Releasing Hormone (GnRH) analog [agonist or antagonist]) with castrate level of serum testosterone (less than [<] 50 nanograms per deciliter [ng/dL] or 1.7 nanomoles per liter [nmol/L]) prior to the first dose of trial intervention and must continue this therapy throughout the treatment phase
- Have discontinued concurrent use of any non-investigational systemic anticancer therapy (that is, cytotoxic chemotherapy, Androgen Receptor Pathway Inhibitor (ARPI), radiation therapy) within 2 weeks or Lutetium-177 Prostate-Specific Membrane Antigen-617 (177^Lu PSMA-617) within 6 weeks prior to first dose of trial intervention, or any investigational drugs within 3 months of first dose of trial intervention
- Toxicity related to prior anticancer treatment that is deemed clinically relevant must have resolved to common terminology criteria for adverse events (CTCAE) Version 6.0 Grade 1 or better
Exclusion Criteria:
- Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
- Suspected or known allergies, hypersensitivity, or intolerance to JNJ-101556143 or its excipients
- Had major surgery or had significant traumatic injury less than or equal to 28 days of the first dose of trial intervention. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate
- Spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
- Solid organ or bone marrow transplantation
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: JNJ-101556143
Participants will receive JNJ-101556143 orally once daily in a 28-day treatment cycle until confirmed radiographic progression by blinded independent central review (BICR) or unequivocal clinical progression, or any other protocol-defined discontinuation criteria is met. |
Participants will receive JNJ-101556143 orally. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Overall Response Rate (ORR)
Ramy czasowe: Up to 2 years and 8 months
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Confirmed overall response, is defined as having either confirmed complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR) prior to any subsequent anti-cancer therapy. |
Up to 2 years and 8 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Duration of Response (DoR)
Ramy czasowe: Up to 2 years and 8 months
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DoR is defined as the time from the date of first documented response for a confirmed radiographic response (CR or PR) per RECIST v1.1 until the date of documented radiographic progression by BICR, or death, whichever comes first. |
Up to 2 years and 8 months
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Radiographic Progression-Free Survival (rPFS)
Ramy czasowe: Up to 2 years and 8 months
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rPFS is defined as the time from the date of initiation of therapy until the date of radiographic disease progression or death, whichever comes first. |
Up to 2 years and 8 months
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Time to Symptomatic Progression (TSP)
Ramy czasowe: Up to 2 years and 8 months
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TSP is defined as the time from the first dose of trial intervention until the date of symptomatic progression or death, whichever comes first. |
Up to 2 years and 8 months
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Number of Participants with Treatment-Emergent Adverse Event (TEAE) by Severity
Ramy czasowe: Up to 2 years and 8 months
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An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale defined as Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. |
Up to 2 years and 8 months
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Number of Participants with Abnormalities in Clinical Laboratory Tests
Ramy czasowe: Up to 2 years and 8 months
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Number of participants with abnormalities in clinical laboratory tests will be reported. |
Up to 2 years and 8 months
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Minimum Plasma Concentration (Cmin) of JNJ-101556143
Ramy czasowe: Pre-dose (0 hours); 2 to 3 hours post dose from Cycle 1 to Cycle 2 and 4 to 8 hours post dose from Cycle 1 to Cycle 2 (Each Cycle Duration= 28 days)
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Minimum plasma concentration of JNJ-101556143 will be reported. |
Pre-dose (0 hours); 2 to 3 hours post dose from Cycle 1 to Cycle 2 and 4 to 8 hours post dose from Cycle 1 to Cycle 2 (Each Cycle Duration= 28 days)
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Maximum Plasma Concentration (Cmax) of JNJ-101556143
Ramy czasowe: Pre-dose (0 hours); 2 to 3 hours post dose from Cycle 1 to Cycle 2 and 4 to 8 hours post dose from Cycle 1 to Cycle 2 (Each Cycle Duration= 28 days)
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Maximum plasma concentration of JNJ-101556143 will be reported. |
Pre-dose (0 hours); 2 to 3 hours post dose from Cycle 1 to Cycle 2 and 4 to 8 hours post dose from Cycle 1 to Cycle 2 (Each Cycle Duration= 28 days)
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Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24h) of JNJ-101556143
Ramy czasowe: Pre-dose (0 hours); 2 to 3 hours post dose from Cycle 1 to Cycle 2 and 4 to 8 hours post dose from Cycle 1 to Cycle 2 (Each Cycle Duration= 28 days)
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AUC0-24h is the area under the plasma concentration-time curve from the time of JNJ-101556143 dose administration up to 24-hour dosing interval. |
Pre-dose (0 hours); 2 to 3 hours post dose from Cycle 1 to Cycle 2 and 4 to 8 hours post dose from Cycle 1 to Cycle 2 (Each Cycle Duration= 28 days)
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Współpracownicy i badacze
Śledczy
- Dyrektor Studium: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 101556143PCR2001
- 101556143PCR2001 (Inny identyfikator: Janssen Research & Development, LLC)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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