Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HSP-130 · 2 trials · 2 indications
Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood.
AUCinf = Area under the serum concentration of HSP-130 versus time curve (AUC) from the time of dose administration to extrapolated infinite time (0-inf).
Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was \< 0.5 x10\^9 per liter. DSN was defined as the days with grade 4 neutropenia (ANC \< 0.5 x10\^9/L).
AUC0-t= Area under the serum concentration of HSP-130 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).
| Arm | Type | Description |
|---|---|---|
| HSP-130 | EXPERIMENTAL | Cycle 0: Regimen A: HSP 130, 3 mg, single SC injection in the deltoid region (n = 6) Regimen B: HSP 130, 6 mg, single SC injection in the deltoid region (n = 6) Cycles 1-4: Regimen B (n = 12): HSP 130, 6 mg, single SC injection in the deltoid region, at least 24 hours after administration of chemotherapy in Cycle 1, Cycle 2, Cycle 3, and Cycle 4. Potential Regimen A (n = 12): 3 mg with background chemotherapy: Inclusion of this cohort will be based on assessment of comparability between Regimens A and B in Cycle 0 for ANC and CD34+ as defined above. If performed, this regimen will be HSP 130, 3 mg, single SC injection in the deltoid region, at least 24 hours after administration of chemotherapy in Cycle 1, Cycle 2, Cycle 3, and Cycle 4, as appropriate. Conditional Regimen C (12 mg):This cohort will not be initiated until data from cycle 0 for 3 mg and 6 mg and Cycles 1-4 for 6 mg has been reviewed and analyzed. |
| Treatment A | OTHER | HSP-130, 6 mg, single subcutaneous (SC) injection in the deltoid region |
| Treatment B | OTHER | US-approved Neulasta, 6 mg, single SC injection in the deltoid region |
| Treatment C | OTHER | EU-approved Neulasta, 6 mg, single SC injection in the deltoid region |
| Name | Type | Description |
|---|---|---|
| HSP-130 | DRUG | Dosage will vary per each cohort: (Five independent cohorts) Cycle 0 Regimen A - 3 mg Cycle 0 Regimen B - 6 mg Cycles 1-4 Regimen B - 6 mg Cycles 1-4 Regimen A (Potential)- 3 mg Cycles 1-4 Regimen C (Conditional)- 12 mg |
| US-approved Neulasta | DRUG | - |
| EU-approved Neulasta | DRUG | - |
Inclusion Criteria: * A subject will be eligible for study participation if all of the following criteria are met at Screening: 1. Is informed, has been given ample time and opportunity to read about participation in the study and has signed and dated the written informed consent form approved b...
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HSP-130 is an investigational small molecule being developed for neutropenia and non-metastatic breast cancer. In clinical trials, it has been studied in healthy participants for neutropenia and in women with breast cancer that has not spread to distant sites. It is administered by subcutaneous injection.
HSP-130 is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE on the New York Stock Exchange. The company has conducted clinical trials of HSP-130 in Australia, Hungary, and Spain.
HSP-130 is in clinical development. One completed trial was a Phase 1 study in healthy participants, and another completed trial was a Phase 2 study in women with non-metastatic breast cancer. HSP-130 is investigational and has not been approved by regulatory authorities.
HSP-130 has been studied in two completed clinical trials. NCT02629289 was a Phase 1 comparative study in healthy participants with neutropenia, enrolling 153 participants in Australia. NCT02650193 was a Phase 2 study of safety and effects in women with non-metastatic breast cancer, enrolling 25 participants in Hungary and Spain.
HSP-130 is a small molecule, but its specific molecular target has not been disclosed. Clinical trials have evaluated its effects on neutropenia and in breast cancer patients, but the mechanism of action is not publicly detailed.