Approval Probability
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Adjusted LOA
ML Risk
JNJ-63898081 · 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 of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death.
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-63898081. Ascending dose levels will be sequentially tested. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants with mCRPC or renal cell carcinoma (RCC) will receive JNJ-63898081 at the recommended Phase 2 dose (RP2D) determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| JNJ-63898081 | DRUG | JNJ-63898081 will be administered. |
Inclusion Criteria: * Histology: Part 1: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed. mCRPC is defined by prostate Cancer Working Group (PCWG )3 criteria. Part 2: mCRPC a...
| 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-63898081 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 developed for patients with advanced stage solid tumors. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
The specific molecular target of JNJ-63898081 has not been disclosed in available information. It is a small molecule therapeutic being investigated for its potential anti-cancer activity in advanced solid tumors. The mechanism of action is not publicly detailed, and the drug is in early-stage clinical development to evaluate its safety and preliminary efficacy.
JNJ-63898081 is being developed by Johnson & Johnson, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical research to evaluate the drug's potential as a treatment for advanced solid tumors. Johnson & Johnson is responsible for the drug's development and regulatory strategy.
JNJ-63898081 is in Phase 1 clinical development. This phase typically involves initial studies in a small number of patients to assess the drug's safety, tolerability, and pharmacokinetics. The drug is investigational and has not received FDA approval. It is being studied in patients with advanced stage solid tumors.
JNJ-63898081 has been studied in one clinical trial, identified as NCT03926013, titled 'A Study of JNJ-63898081 in Participants With Advanced Stage Solid Tumors.' This Phase 1 trial enrolled 40 participants with neoplasms and was conducted in the United States and Canada. The trial has been completed, and no active trials are currently listed for this drug.
No alternative names for JNJ-63898081 have been identified in available information. The drug is known by its investigational code name JNJ-63898081. It is a unique small molecule being developed by Johnson & Johnson for oncology indications. No other names or aliases have been associated with this compound in public records.