En studie av JNJ-87189401 Plus JNJ-78278343 for avansert prostatakreft
En fase 1-studie av JNJ-87189401 (PSMA-CD28 bispesifikt antistoff) kombinert med JNJ-78278343 (KLK2-CD3 bispesifikt antistoff) for avansert prostatakreft
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-post: Participate-In-This-Study1@its.jnj.com
Studiesteder
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Greenslopes, Australia, 4120
- Rekruttering
- Greenslopes Private Hospital
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Melbourne, Australia, 3000
- Rekruttering
- Peter MacCallum Cancer Centre
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Rekruttering
- University of Colorado Anschutz Medical Campus
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Rekruttering
- Emory University Winship Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455
- Rekruttering
- University Of Minnesota
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New Jersey
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East Brunswick, New Jersey, Forente stater, 08816
- Rekruttering
- START New Jersey
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New York
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New York, New York, Forente stater, 10032
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- Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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The Bronx, New York, Forente stater, 10467
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- Montefiore Medical Center
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North Carolina
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Charlotte, North Carolina, Forente stater, 28204
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- Atrium Health Levine Cancer Institute
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Oregon
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Portland, Oregon, Forente stater, 97239
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- Oregon Health And Science University
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
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- Sidney Kimmel Cancer Center - Jefferson Health
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Rekruttering
- Tennessee Oncology
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Texas
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Houston, Texas, Forente stater, 77030
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- MD Anderson Cancer Center
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San Antonio, Texas, Forente stater, 78229
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- South Texas Accelerated Research Therapeutics, LLC (START)
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Washington
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Seattle, Washington, Forente stater, 98104
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- Swedish Medical Center
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Bordeaux, Frankrike, 33000
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- Institut Bergonie
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Lyon, Frankrike, 69008
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- Centre Leon Berard
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Villejuif, Frankrike, 94800
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- Institut Gustave Roussy
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Tokyo, Japan, 135 8550
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- The Cancer Institute Hospital of JFCR
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Chongqing, Kina, 400030
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- Chongqing University Cancer Hospital
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Wenzhou, Kina, 325000
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- The First Affiliated Hospital of Wenzhou Medical University
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Xi'an, Kina, 710004
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- The First Affiliated Hospital of Xian Jiaotong University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
JNJ-78278343 will be administered.
Andre navn:
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Eksperimentell: 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.
Andre navn:
JNJ-78278343 will be administered.
Andre navn:
Apalutamide will be administered. |
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Eksperimentell: 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.
Andre navn:
JNJ-78278343 will be administered.
Andre navn:
Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment. |
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Eksperimentell: 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.
Andre navn:
JNJ-78278343 will be administered.
Andre navn:
JNJ-101556143 will be administered.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Serum Concentrations of JNJ-87189401 and JNJ-78278343
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR109330
- 87189401PCR1001 (Annen identifikator: Janssen Research & Development, LLC)
- 2023-504063-17-00 (Registeridentifikator: EUCT number)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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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