ClinicaliQ Trial Snapshot
- A Study of JNJ-78278343 in Combination With JNJ-95298177 for Treatment of Prostate Cancer — Recruiting • Phase I • Oncology • NCT07082920.
- What is being tested: A Phase 1b/2 dose-escalation study evaluating the combination of two investigational agents (JNJ-78278343 and JNJ-95298177) in prostate cancer, with Part 1 establishing the recommended Phase 2 combination dose and Part 2 assessing safety and tolerability at that dose.
- Patient eligibility overview: The trial enrolls patients with prostate cancer (likely advanced/metastatic based on combination therapy approach); specific eligibility criteria typically include adequate organ function, prior treatment history, and performance status requirements, though full criteria require review of the complete protocol.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * 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 * Must have metastatic castration-resistant prostate cancer (mCRPC) * PSA must measure at least 2 nanograms per milliliters (ng/mL) at screening * Measurable or evaluable disease * Prior orchiectomy or medical castration; or, for 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 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.