En studie av JNJ-87189401 Plus JNJ-78278343 för avancerad prostatacancer
En fas 1-studie av JNJ-87189401 (PSMA-CD28 bispecifik antikropp) kombinerad med JNJ-78278343 (KLK2-CD3 bispecifik antikropp) för avancerad prostatacancer
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studieorter
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Greenslopes, Australien, 4120
- Rekrytering
- Greenslopes Private Hospital
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Melbourne, Australien, 3000
- Rekrytering
- Peter MacCallum Cancer Centre
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Bordeaux, Frankrike, 33000
- Rekrytering
- Institut Bergonie
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Lyon, Frankrike, 69008
- Rekrytering
- Centre Leon Berard
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Villejuif, Frankrike, 94800
- Rekrytering
- Institut Gustave Roussy
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- Rekrytering
- University of Colorado Anschutz Medical Campus
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Rekrytering
- Emory University Winship Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55455
- Rekrytering
- University Of Minnesota
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New Jersey
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East Brunswick, New Jersey, Förenta staterna, 08816
- Rekrytering
- START New Jersey
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New York
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New York, New York, Förenta staterna, 10032
- Rekrytering
- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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The Bronx, New York, Förenta staterna, 10467
- Rekrytering
- Montefiore Medical Center
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28204
- Rekrytering
- Atrium Health Levine Cancer Institute
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Oregon
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Portland, Oregon, Förenta staterna, 97239
- Rekrytering
- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19107
- Rekrytering
- Sidney Kimmel Cancer Center - Jefferson Health
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37203
- Rekrytering
- Tennessee Oncology
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Texas
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Houston, Texas, Förenta staterna, 77030
- Rekrytering
- MD Anderson Cancer Center
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San Antonio, Texas, Förenta staterna, 78229
- Rekrytering
- South Texas Accelerated Research Therapeutics, LLC (START)
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Washington
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Seattle, Washington, Förenta staterna, 98104
- Rekrytering
- Swedish Medical Center
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Tokyo, Japan, 135 8550
- Rekrytering
- The Cancer Institute Hospital of JFCR
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Chongqing, Kina, 400030
- Rekrytering
- Chongqing University Cancer Hospital
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Wenzhou, Kina, 325000
- Rekrytering
- The First Affiliated Hospital of Wenzhou Medical University
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Xi'an, Kina, 710004
- Rekrytering
- The First Affiliated Hospital of Xian Jiaotong University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
Andra namn:
JNJ-78278343 will be administered.
Andra namn:
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Experimentell: 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.
Andra namn:
JNJ-78278343 will be administered.
Andra namn:
Apalutamide will be administered. |
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Experimentell: 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.
Andra namn:
JNJ-78278343 will be administered.
Andra namn:
Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment. |
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Experimentell: 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.
Andra namn:
JNJ-78278343 will be administered.
Andra namn:
JNJ-101556143 will be administered.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Serum Concentrations of JNJ-87189401 and JNJ-78278343
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Utredare
- Studierektor: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CR109330
- 87189401PCR1001 (Annan identifierare: Janssen Research & Development, LLC)
- 2023-504063-17-00 (Registeridentifierare: EUCT number)
- 2023 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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
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