Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NPI-0052 on Days 1, 8, 15 every 28 days · 1 trial · 1 indication
Assess dose-limiting toxicities during Cycle 1 for each treatment arm
| Arm | Type | Description |
|---|---|---|
| Arm AM: advanced malignancies | EXPERIMENTAL | Dose Escalation - 9 dose cohorts NPI-0052 on Days 1, 8, 15 every 28 days NPI-0052 doses ranging from 0.1 to 0.9 mg/m2 |
| Arm MM: multiple myeloma | EXPERIMENTAL | Dose Escalation - 8 dose cohorts NPI-0052 on Days 1, 4, 8, 11 every 21 days NPI-0052 doses ranging from 0.075 to 0.6 mg/m2 Dexamethasone 20 mg oral or IV day before and day after NPI-0052 dosing. |
| Name | Type | Description |
|---|---|---|
| NPI-0052 on Days 1, 8, 15 every 28 days | DRUG | NPI-0052 dose ranging from 0.1 to 0.9 mg/m2 NPI-0052 IV injection over 1 to 120 minutes on Days 1, 8, and 15 of 4-week cycles |
| NPI-0052 on Days 1, 4, 8, 11 every 21 days | DRUG | NPI-0052 dose ranging from 0.075 to 0.6 mg/m2 NPI-0052 IV injection over 1 to 120 minutes on Days 1, 4, 8, and 11 of 3-week cycles |
| Dexamethasone | DRUG | 20 mg oral or IV day before and day after NPI-0052 dosing. |
Inclusion Criteria: * Karnofsky Performance Status (KPS) \> 70%. * Histologically-confirmed advanced malignancy for which a standard, approved therapy is not available. * Adequate renal, liver, pancreatic and hematologic function * Signed informed consent (sample IC form is provided in Appendix A)....
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
NPI-0052 is an investigational small molecule being studied for the treatment of advanced cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities. The drug is being evaluated in patients with advanced malignancies to assess its safety and potential efficacy.
NPI-0052 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research to evaluate the drug's potential in treating advanced cancer.
NPI-0052 is in Phase 1 clinical development. This is an early stage of testing that primarily focuses on evaluating the drug's safety, tolerability, and dosing in patients. The drug is investigational and has not been approved by regulatory authorities for commercial use.
NPI-0052 has been studied in one completed Phase 1 clinical trial registered as NCT00629473. This trial, titled 'Phase 1 Clinical Trial of NPI-0052 in Patients With Advanced Malignancies,' enrolled 86 participants with advanced cancer in Australia. The trial included adults aged 18 years and older.
NPI-0052 is also known by the name marizomib, which is an alternative name for the same investigational drug. This compound is being developed by Bristol-Myers Squibb Company for the treatment of advanced cancer. Both names refer to the same drug candidate in clinical development.