A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate C… (NCT07319871) | Clinical Trial Compass
RecruitingPhase 1
A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer
United States, United Kingdom40 participantsStarted 2026-01-14
Plain-language summary
The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of Pasritamig in combination with JNJ-86974680 in Part 1 (Dose finding) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with advanced prostate cancer in Part 2 (Dose expansion) of study.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate. Primary small cell carcinoma, carcinoid tumor, neuroendocrine (NE) carcinoma, or large cell NE carcinoma arising in the prostate are not allowed; however, adenocarcinomas with NE features (for example \[e.g.\], immunohistochemistry \[IHC\] with both androgen receptor \[AR\]- and NE-marker positivity) are allowed
* Metastatic castration-resistant prostate cancer (mCRPC) that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs. Local-regional invasion (rectum, bladder) and bone disease with soft tissue component can be included
* Prior orchiectomy or medical castration (for example, 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)
* Prostate-specific antigen (PSA) greater than or equal to (\>=) 2 nanograms per milliliters (ng/mL) at screening
* Measurable or evaluable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria:
* Toxicity related to prior anticancer therapy that has not returned to grade less than or equal to (\<=) 1 or baseline levels (except for alopecia, neuropathy \[Grade 2\] and vitiligo)
* Known allergies, hypersensitivity, or intolerance to any of the components (for example, excipients) of pas…
What they're measuring
1
Number of Participants With Adverse Events (AEs) by Severity
Timeframe: Up to 1 year 2 months
2
Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)