A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07082920
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 intravenously.
  • JNJ-95298177 — DRUG
    JNJ-95298177 will be administered intravenously.

Study Details

The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of JNJ-78278343 in combination with JNJ-95298177 in Part 1 (Dose confirmation) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of prostate cancer where the cancer has spread beyond the prostate and is resistant to hormonal therapy) in Part 2 (Dose expansion) of study.

Key Dates

Start date
Jul 7, 2025
Status verified
Jun 2026
Primary completion
Jan 28, 2027
Completion
Mar 1, 2027

Study Design

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

Arms

  • Experimental: Part 1: Dose Confirmation
    Participants will receive JNJ-78278343 in combination with JNJ-95298177 in a dose de-escalation schedule in accordance with the Bayesian Optimal Interval Design (BOIN) design to determine the recommended phase 2 combination dose (RP2CD) regimen.
  • Experimental: Part 2: Dose Expansion
    Participants will receive JNJ-78278343 in combination with JNJ-95298177 at the RP2CD as determined in Part 1 of the study to confirm the safety and anti-tumor activity.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) by Severity [ Time Frame: Up to 2 years 2 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsSarasotaFlorida34232-
Columbia University Medical CenterNew YorkNew York10032-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Fred Hutchinson Cancer CenterSeattleWashington98109-

Find similar trials in Sarasota, FL

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Florida Cancer Specialists· Sarasota, FLColumbia University Medical Center· New York, NYUniversity Hospitals Cleveland Medical Center· Cleveland, OHFred Hutchinson Cancer Center· Seattle, WA

Related Studies