Een onderzoek naar JNJ-87189401 plus JNJ-78278343 voor gevorderde prostaatkanker
Een fase 1-studie van JNJ-87189401 (PSMA-CD28 bispecifiek antilichaam) gecombineerd met JNJ-78278343 (KLK2-CD3 bispecifiek antilichaam) voor gevorderde prostaatkanker
The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Study Contact
- Telefoonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Studie Locaties
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Greenslopes, Australië, 4120
- Werving
- Greenslopes Private Hospital
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Melbourne, Australië, 3000
- Werving
- Peter MacCallum Cancer Centre
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Chongqing, China, 400030
- Werving
- Chongqing University Cancer Hospital
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Wenzhou, China, 325000
- Werving
- The First Affiliated Hospital of Wenzhou Medical University
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Xi'an, China, 710004
- Werving
- The First Affiliated Hospital of Xian Jiaotong University
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Bordeaux, Frankrijk, 33000
- Werving
- Institut Bergonie
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Lyon, Frankrijk, 69008
- Werving
- Centre Leon Berard
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Villejuif, Frankrijk, 94800
- Werving
- Institut Gustave Roussy
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Tokyo, Japan, 135 8550
- Werving
- The Cancer Institute Hospital of JFCR
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- Werving
- University of Colorado Anschutz Medical Campus
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Werving
- Emory University Winship Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55455
- Werving
- University Of Minnesota
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New Jersey
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East Brunswick, New Jersey, Verenigde Staten, 08816
- Werving
- START New Jersey
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New York
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New York, New York, Verenigde Staten, 10032
- Werving
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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The Bronx, New York, Verenigde Staten, 10467
- Werving
- Montefiore Medical Center
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28204
- Werving
- Atrium Health Levine Cancer Institute
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Oregon
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Portland, Oregon, Verenigde Staten, 97239
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- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
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- Sidney Kimmel Cancer Center - Jefferson Health
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37203
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- Tennessee Oncology
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Texas
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Houston, Texas, Verenigde Staten, 77030
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- MD Anderson Cancer Center
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San Antonio, Texas, Verenigde Staten, 78229
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- South Texas Accelerated Research Therapeutics, LLC (START)
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Washington
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Seattle, Washington, Verenigde Staten, 98104
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- Swedish Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed
- Measurable or evaluable disease per PCWG3 criteria
- Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, must be receiving ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analog (agonist or antagonist), prior to the first dose of study drug and must continue this therapy throughout the treatment phase
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- History of an autoimmune disease within the 12 months prior to signing consent
- Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association [NYHA] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Part 1 (Dose Escalation)
Participants will receive JNJ-78278343 + JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R). |
JNJ-87189401 will be administered.
Andere namen:
JNJ-78278343 will be administered.
Andere namen:
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Experimenteel: Part 2 (Dose Expansion)
Participants with different disease settings in Parts 2A and 2B will receive JNJ-78278343+JNJ-87189401 at the RP2R selected in Part 1. Participants in Part 2C will receive apalutamide plus continued treatment with JNJ-87189401+JNJ-78278343 doublet. |
JNJ-87189401 will be administered.
Andere namen:
JNJ-78278343 will be administered.
Andere namen:
Apalutamide will be administered. |
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Experimenteel: Part 3
Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) selected in Part 1 along with standard of care (SOC) treatment with lutetium Lu-177 vipivotide tetraxetan. Dosing of JNJ-78278343+JNJ-87189401 will be escalated sequentially, as per study evaluation team (SET) decision. |
JNJ-87189401 will be administered.
Andere namen:
JNJ-78278343 will be administered.
Andere namen:
Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment. |
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Experimenteel: Part 4
Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) along with JNJ-101556143. Dosing of JNJ-78278343+JNJ-87189401 along with JNJ-101556143 will be escalated sequentially to determine the RP2R of the combinations. |
JNJ-87189401 will be administered.
Andere namen:
JNJ-78278343 will be administered.
Andere namen:
JNJ-101556143 will be administered.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)
Tijdsspanne: Up to 21 days after first combination dose of study drugs
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DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity. |
Up to 21 days after first combination dose of study drugs
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Number of Participants with Adverse Events (AEs) by Severity
Tijdsspanne: Up to 4 years 8 months
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event. |
Up to 4 years 8 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Serum Concentrations of JNJ-87189401 and JNJ-78278343
Tijdsspanne: Up to 4 years 8 months
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Serum samples will be analyzed to determine concentrations of JNJ-87189401 and JNJ-78278343. |
Up to 4 years 8 months
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Plasma Concentration of JNJ-101556143
Tijdsspanne: Up to 4 years 8 months
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Plasma samples will be analyzed to determine concentrations of JNJ-101556143. |
Up to 4 years 8 months
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Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
Tijdsspanne: Up to 4 years 8 months
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Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported. |
Up to 4 years 8 months
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Objective Response Rate (ORR)
Tijdsspanne: Up to 4 years 8 months
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ORR is defined as the proportion of participants who have a partial response (PR) or better according to response evaluation criteria in solid tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3). |
Up to 4 years 8 months
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Radiographic Progression-Free Survival (rPFS)
Tijdsspanne: Up to 4 years 8 months
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rPFS is defined time from the date of first dose of study drug until the date of objective disease progression or death, whichever comes first. |
Up to 4 years 8 months
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Prostate Specific Antigen (PSA) Response Rate
Tijdsspanne: Up to 4 years 8 months
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PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline. |
Up to 4 years 8 months
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Duration of Response (DOR)
Tijdsspanne: Up to 4 years 8 months
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DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first. |
Up to 4 years 8 months
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Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CR109330
- 87189401PCR1001 (Andere identificatie: Janssen Research & Development, LLC)
- 2023-504063-17-00 (Register-ID: EUCT number)
- 2023 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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
Informatie over medicijnen en apparaten, studiedocumenten
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