Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04644770 | A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 144 | — | — | Nov 12, 2020 | Dec 8, 2026 | Jun 5, 2026 | 11 | United States |
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | Participants will receive JNJ-69086420 with one or multiple doses. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants in one or more cohorts will receive JNJ-69086420 at the RP2D(s) determined in Part 1. |
| Part 3: Combination Therapy | EXPERIMENTAL | Participants will receive JNJ-69086420 at the determined RP2D(s) and fixed dose of JNJ-78278343. |
| Part 4: HSPC Expansion | EXPERIMENTAL | Participants with HSPC will receive JNJ-69086420 at the RP2D(s) in Part 4(a), and JNJ-69086420 following stereotactic body radiation therapy in Part 4(b). |
| Name | Type | Description |
|---|---|---|
| JNJ-69086420 | DRUG | Participants will receive JNJ-69086420. |
| JNJ-78278343 | DRUG | Participants will receive JNJ-78278343. |
| Stereotactic body radiation therapy | RADIATION | Participants will receive stereotactic body radiaition therapy. |
Inclusion Criteria: * For Part 1, Part 2, Part 3: Metastatic castration resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma (adenocarcinoma with small-cell or neuroendocrine features is allowed) with prior exposure to at least one androgen receptor (AR) targeted therapy...