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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06095089
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JNJ-78278343 — DRUG
    JNJ-78278343 will be administered.
  • JNJ-87189401 — DRUG
    JNJ-87189401 will be administered.
  • Apalutamide — DRUG
    Apalutamide will be administered.
  • Lutetium Lu-177 Vipivotide Tetraxetan — DRUG
    Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment.
  • JNJ-101556143 — DRUG
    JNJ-101556143 will be administered.

Study Details

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.

Key Dates

Start date
Nov 1, 2023
Status verified
Jun 2026
Primary completion
Jun 21, 2027
Completion
Jun 28, 2028

Study Design

Enrollment
355 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 (Dose Escalation)
    Participants will receive JNJ-78278343 + JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R).
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Up to 21 days after first combination dose of study drugs ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical CampusAuroraColorado80045-
Emory University Winship Cancer InstituteAtlantaGeorgia30322-
University Of MinnesotaMinneapolisMinnesota55455-
START New JerseyEast BrunswickNew Jersey08816-
Herbert Irving Comprehensive Cancer Center Columbia University Medical CenterNew YorkNew York10032-
Oregon Health And Science UniversityPortlandOregon97239-
Sidney Kimmel Cancer Center - Jefferson HealthPhiladelphiaPennsylvania19107-
Tennessee OncologyNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research Therapeutics, LLC (START)San AntonioTexas78229-
Swedish Medical CenterSeattleWashington98104-

Find similar trials in Aurora, CO

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Colorado Anschutz Medical Campus· Aurora, COEmory University Winship Cancer Institute· Atlanta, GAUniversity Of Minnesota· Minneapolis, MNSTART New Jersey· East Brunswick, NJHerbert Irving Comprehensive Cancer Center Columbia University Medical Center· New York, NYOregon Health And Science University· Portland, OR

Related Studies