Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-98768111 · 1 trial · 1 indication
An AE is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment.
High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT. Other DLT criteria includes any related toxicity resulting in permanent treatment discontinuation or a delay in dose administration greater than (\>)14 days and any death not clearly due to the underlying disease or non-trial intervention-related causes.
| Arm | Type | Description |
|---|---|---|
| JNJ-98768111 | EXPERIMENTAL | Participants in Part 1 of the study will receive escalating doses of JNJ-98768111 to identify the putative recommended phase 2 dose (pRP2D) regimen(s). Participants in Part 2 of the study will receive JNJ-98768111 at the pRP2D regimen(s) determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-98768111 | DRUG | JNJ-98768111 will be administered intravenously. |
Inclusion criteria: * a. Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine features is permitted. b. Measurable or evaluable disease (metastatic prostate cancer) based on computed tomography (CT), magnetic resonance imaging (MRI), or bone scan...
JNJ-98768111 is an investigational small molecule developed by Johnson & Johnson for the treatment of prostatic neoplasms, or prostate cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with advanced prostate cancer.
JNJ-98768111 is being developed for the treatment of prostatic neoplasms, specifically advanced prostate cancer. It is an investigational therapy and is not yet approved for any indication. The ongoing Phase 1 trial is evaluating its use in adult male participants with advanced prostate cancer.
JNJ-98768111 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker symbol JNJ. The company is responsible for the clinical development of this small molecule for prostate cancer.
JNJ-98768111 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The Phase 1 trial is currently recruiting participants and is designed to evaluate the drug in advanced prostate cancer.
JNJ-98768111 is being studied in one active clinical trial, NCT07746713, titled A Study of JNJ-98768111 in Participants With Advanced Prostate Cancer. The trial is currently recruiting and plans to enroll 100 male participants aged 18 years and older in the United States and Israel.