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JNJ-70218902 · 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 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.
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), 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.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-70218902. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-70218902 | DRUG | JNJ-70218902 will be administered. |
Inclusion Criteria: * Histology: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed * Measurable or evaluable disease * Prior treatment with at least 1 prior novel androgen rece...
| 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-70218902 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 currently in Phase 1 clinical development for advanced stage solid tumors. The drug is administered to adult male participants aged 18 years and older.
JNJ-70218902 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 oncology drug candidate.
JNJ-70218902 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for the treatment of advanced solid tumors.
JNJ-70218902 has one completed Phase 1 clinical trial registered under NCT04397276, titled "A Study of JNJ-70218902 in Participants With Advanced Stage Solid Tumors." The trial enrolled 82 participants and was conducted in Canada, Israel, and Spain. It was a controlled study, though not randomized or double-blinded.
JNJ-70218902 is the designated name for this investigational compound. No alternative names have been established for this drug candidate in the available clinical trial information. It is identified solely by its JNJ-70218902 designation in the research context.