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JNJ-79032421 · 1 trial · 1 indication
The DLTs are adverse events including certain high grade non-hematologic or hematologic toxicities, or toxicities meeting other specific criteria.
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events (ICANS), which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. 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): JNJ-79032421 | EXPERIMENTAL | In Part 1 (Dose escalation), participants will receive JNJ-79032421. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. |
| Part 2 (Dose Expansion): JNJ-79032421 | EXPERIMENTAL | In Part 2 (Dose expansion), participants will receive JNJ-79032421 at the RP2D regimen(s) determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-79032421 | DRUG | JNJ-79032421 will be administered. |
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of one of the following unresectable/locally advanced or metastatic solid tumors: a) Ovarian cancer includes high grade serous epithelial ovary, fallopian tube, or primary peritoneal cancer. Participants must have progressed ...
JNJ-79032421 is an investigational small molecule being studied for the treatment of advanced stage solid tumors. It is in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in a clinical trial in Spain.
JNJ-79032421 targets mesothelin, a protein that is often overexpressed in certain solid tumors. By targeting mesothelin, the drug aims to interfere with tumor growth. This mechanism is being investigated in a Phase 1 study for advanced stage solid tumors.
JNJ-79032421 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical research on this investigational drug for oncology indications.
JNJ-79032421 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 1 study has been completed, and the drug remains under evaluation for safety and efficacy.
JNJ-79032421 has one completed clinical trial, identified as NCT06255665. This Phase 1 study enrolled 35 participants with advanced stage solid tumors and was conducted in Spain. The trial was controlled but not randomized or double-blinded, and it included adults aged 18 years and older.
JNJ-79032421 is the primary name for this investigational drug. No alternative names have been reported in the available clinical trial information. It is a distinct small molecule being developed by Johnson & Johnson for advanced stage solid tumors.