Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-78306358 · 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.
Number of participants with AEs by severity will be reported. 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 (ICANS) events, which will be graded according to the 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.
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.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | Participants with renal cell carcinoma (RCC), ovarian cancer, colorectal cancer (CRC), and other tumor types with sponsor approval will receive JNJ-78306358. The dose will be escalated sequentially based on the decisions of the study evaluation team until the recommended phase 2 dose (RP2D) regimen(s) have been identified. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants with RCC, ovarian cancer, CRC and other types of tumors will receive JNJ-78306358 at the RP2D regimen(s) determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-78306358 | DRUG | JNJ-78306358 will be administered. |
Inclusion Criteria * Histologically or cytologically confirmed, metastatic or unresectable solid tumor of one of the following types: a. Renal Cell Carcinoma (RCC): clear cell or papillary carcinoma, b. ovarian cancer: high grade serous epithelial ovarian; primary peritoneal or fallopian tube ca...
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| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
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JNJ-78306358 is an investigational small molecule developed by Johnson & Johnson for the treatment of advanced stage solid tumors, or neoplasms. It has been studied in a single Phase 1 clinical trial and is not an approved therapy. The trial enrolled 39 participants with advanced solid tumors.
JNJ-78306358 is being studied for use in neoplasms, specifically advanced stage solid tumors. It is an investigational agent in Phase 1 development and has no approved indication. The one completed trial enrolled 39 adult participants with advanced solid tumors in Israel and Spain.
JNJ-78306358 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 1 study of the compound in participants with advanced stage solid tumors.
JNJ-78306358 is in Phase 1 development. One Phase 1 trial, NCT04991740, has been completed, and no active trials are currently listed. The study enrolled 39 participants and was conducted in Israel and Spain. The drug is investigational and has not been approved by the FDA.
JNJ-78306358 has been evaluated in one clinical trial, NCT04991740, titled A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors. That Phase 1 trial is completed, enrolled 39 participants aged 18 years and older, and took place in Israel and Spain. It was a controlled study with biomarker-selected participants.
No. JNJ-78306358 is an investigational small molecule in Phase 1 clinical development and has not been approved by the FDA. Its only listed trial, NCT04991740, has completed with 39 participants enrolled, and no active trials are currently reported for the compound.