A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer

NCT06095089
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
355
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Lead sponsor
Janssen Research & Development, LLC
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Start date
2023-11-01
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Number of sites
19
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Summary
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.
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Short title
A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
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Official title
A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-06-28
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First posted
2023-10-23
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Registry last updated
2026-08-28
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Primary completion date
2027-06-21
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Start date
2023-11-01
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Participants
355
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Participant count basis
Estimated
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Planned participants
355
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Protocol amendments
3
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Number of sites
19
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Janssen Research & Development, LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06095089
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ClinicalTrials.gov ID
NCT06095089
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)

    Timeframe: Up to 21 days after first combination dose of study drugs

    DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.

  2. Number of Participants with Adverse Events (AEs) by Severity

    Timeframe: Up to 4 years 8 months

    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.

  1. Serum Concentrations of JNJ-87189401 and JNJ-78278343

    Timeframe: Up to 4 years 8 months

    Serum samples will be analyzed to determine concentrations of JNJ-87189401 and JNJ-78278343.

  2. Plasma Concentration of JNJ-101556143

    Timeframe: Up to 4 years 8 months

    Plasma samples will be analyzed to determine concentrations of JNJ-101556143.

  3. Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343

    Timeframe: Up to 4 years 8 months

    Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported.

  4. Objective Response Rate (ORR)

    Timeframe: Up to 4 years 8 months

    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).

  5. Radiographic Progression-Free Survival (rPFS)

    Timeframe: Up to 4 years 8 months

    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.

  6. Prostate Specific Antigen (PSA) Response Rate

    Timeframe: Up to 4 years 8 months

    PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline.

  7. Duration of Response (DOR)

    Timeframe: Up to 4 years 8 months

    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.

Sources for outcomes
clinicaltrials.gov

Sex
Male
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • University of Colorado Anschutz Medical CampusAurora, United StatesRecruiting
  • Emory University Winship Cancer InstituteAtlanta, United StatesRecruiting
  • University Of MinnesotaMinneapolis, United StatesRecruiting
  • START New JerseyEast Brunswick, United StatesRecruiting
  • Herbert Irving Comprehensive Cancer Center Columbia University Medical CenterNew York, United StatesRecruiting
  • Atrium Health Levine Cancer InstituteCharlotte, United StatesRecruiting
  • Oregon Health And Science UniversityPortland, United StatesRecruiting
  • Sidney Kimmel Cancer Center - Jefferson HealthPhiladelphia, United StatesRecruiting
  • Tennessee OncologyNashville, United StatesRecruiting
  • MD Anderson Cancer CenterHouston, United StatesRecruiting
  • South Texas Accelerated Research Therapeutics, LLC (START)San Antonio, United StatesRecruiting
  • Swedish Medical CenterSeattle, United StatesRecruiting
  • Greenslopes Private HospitalGreenslopes, AustraliaRecruiting
  • Peter MacCallum Cancer CentreMelbourne, AustraliaRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaRecruiting
  • Institut BergonieBordeaux, FranceRecruiting
  • Centre Leon BerardLyon, FranceRecruiting
  • Institut Gustave RoussyVillejuif, FranceRecruiting
  • The Cancer Institute Hospital of JFCRTokyo, JapanRecruiting
Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-504063-17-00
  • 87189401PCR1001
Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (2)