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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
JNJ-78306358 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is being evaluated in patients with advanced stage solid tumors. The drug is currently in Phase 1 clinical development.
JNJ-78306358 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 to evaluate the safety and efficacy of this investigational oncology drug.
JNJ-78306358 is in Phase 1 clinical development. A Phase 1 study of the drug in participants with advanced stage solid tumors has been completed. The drug is investigational and has not been approved by regulatory authorities for commercial use.
JNJ-78306358 has been studied in one clinical trial, identified as NCT04991740, titled "A Study of JNJ-78306358 in Participants With Advanced Stage Solid Tumors." This Phase 1 trial enrolled 39 participants and was conducted in Israel and Spain. The trial has been completed.
JNJ-78306358 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A completed Phase 1 trial evaluated the drug in patients with advanced stage solid tumors, but the drug has not yet received regulatory approval for any indication.