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JNJ-69086420 · 1 trial · 2 indications
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...
JNJ-69086420 is an investigational small molecule being developed for the treatment of prostatic neoplasms, specifically advanced prostate cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
JNJ-69086420 is an Actinium-225-labeled antibody that targets human Kallikrein-2 (hK2), a protein associated with prostate cancer cells. By binding to hK2, the drug delivers a radioactive payload to cancer cells, potentially causing targeted cell death.
JNJ-69086420 is being developed by Johnson & Johnson, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol JNJ.
JNJ-69086420 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is active but not recruiting participants.
JNJ-69086420 is being studied in a single Phase 1 clinical trial with the identifier NCT04644770. This trial is investigating the drug in patients with advanced prostate cancer and has an enrollment of 144 participants. The study is being conducted in the United States.
Yes, JNJ-69086420 is an Actinium-225-labeled antibody targeting human Kallikrein-2 (hK2). This means the drug combines a monoclonal antibody with the radioactive isotope Actinium-225 to deliver targeted radiation therapy to prostate cancer cells.