Clinical trial · Interventional
A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer
A Phase 1 Study of JNJ-80038114, a T-Cell Redirecting Agent Targeting Prostate Specific Membrane Antigen (PSMA), for Advanced Stage Prostate Cancer
NCT05441501CI-TRIAL-00086734completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-80038114 in Part 1 (dose escalation) and to determine the safety at the RP2D(s) in Part 2 (dose expansion).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JNJ-80038114 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1: Dose Escalation
- description
- Participants will receive JNJ-80038114. The dose levels will be escalated based on the dose limiting toxicities (DLTs) evaluation by the study evaluation team (SET).
- interventionNames
- Drug: JNJ-80038114
- type
- EXPERIMENTAL
- label
- Part 2: Dose Expansion
- description
- Participants will receive JNJ-80038114 at the recommended Phase 2 dose (RP2D) determined in Part 1.
- interventionNames
- Drug: JNJ-80038114
Primary outcomes (3)
- measure
- Parts 1 and 2: Number of Participants With Adverse Events (AEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3) * Measurable or evaluable disease * At least 1 prior treatment for mCRPC * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ functions as defined by certain laboratory values * Must sign an informed consent form (ICF) * Participants must agree to use a highly effective form of birth control as guided by the study doctor Exclusion Criteria: * Concurrent anticancer therapy * Severe or long-lasting side effects related to prior anticancer therapy * Known allergies to JNJ-80038114 or its excipients * Brain metastasis or known seizure history * Significant infections or lung, heart or other medical conditions
References
Publications (1)
- DERIVEDHudson A, Jayaram A, Garmezy B, Zorko NA, Zarrabi KK, Mathews L, Rupnow B, Li M, Ghosh D, Urtishak K, Francis P, Wang SC, Attiyeh E, de Bono J. A phase 1, first-in-human, dose escalation study of JNJ-80038114, a PSMAxCD3 bispecific antibody, in participants with metastatic castration-resistant prostate cancer. Cancer Chemother Pharmacol. 2026 Jan 6;96(1):5. doi: 10.1007/s00280-025-04846-w. PMID 41493473