Approval Probability
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Adjusted LOA
ML Risk
JNJ-80038114 · 1 trial · 1 indication
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.
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. Cytokine release syndrome (CRS) and associated neurologic toxicity events will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | 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). |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants will receive JNJ-80038114 at the recommended Phase 2 dose (RP2D) determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-80038114 | DRUG | JNJ-80038114 will be administered. |
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) perf...
JNJ-80038114 is an investigational small molecule being studied for the treatment of prostatic neoplasms, specifically advanced stage prostate cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
JNJ-80038114 is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is an investigational small molecule in Phase 1 clinical development for prostate cancer.
JNJ-80038114 is in Phase 1 clinical development. It is an investigational small molecule being studied for the treatment of advanced stage prostate cancer. The drug has not been approved by regulatory authorities and remains in early-stage clinical testing.
JNJ-80038114 has one completed Phase 1 clinical trial, identified as NCT05441501, which studied the drug in participants with advanced stage prostate cancer. The trial enrolled 39 male participants aged 18 years and older in the United States and United Kingdom.
JNJ-80038114 is a unique investigational small molecule developed by Johnson & Johnson. No alternative names for this drug have been identified in the available clinical trial information.