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Also known as palifosfamide, Palifosfamide-Tris, isophosphoramide mustard
ZIO-201 · 4 trials · 11 indications
To assess the effect of single-agent palifosfamide-tris on QTc intervals.
To assess the pharmacokinetic profile of single-agent palifosfamide-tris.
Adverse events, vital signs, physical examination, laboratory data and concomitant medications
DLTs were assessed during the first 21-day cycle to determine the maximum tolerated dose (MTD). A DLT was defined as any of the following: a non-hematologic Grade 3 toxicity that did not resolve to Grade 2 or lower within 72 hours, excluding alopecia any non-hematologic Grade 4 toxicity, excluding alopecia Grade 4 granulocyte and/or platelet toxicity lasting 7 days or longer Grade 3 or higher neutropenia with an unexplained temperature of 38.5°C or higher on 2 or more occasions within 24 hours The MTD was the dose level below the dose at which at least 33% of participants had a DLT.
| Arm | Type | Description |
|---|---|---|
| Single Arm | OTHER | Single Arm, non-blinded, non-randomized |
| PaCE | EXPERIMENTAL | Palifosfamide, Carboplatin and Etoposide |
| Phase 1: Palifosfamide-lysine 590 mg/m² | EXPERIMENTAL | Participants received palifosfamide-lysine 590 mg/m² by intravenous infusion over approximately 15 minutes on Days 1, 2, and 3 of each 21-day cycle. Four participants were treated at this dose level. Dose escalation was discontinued after 2 of 4 participants experienced dose-limiting toxicities during Cycle 1. |
| Phase 2: Palifosfamide-lysine 413 mg/m² | EXPERIMENTAL | Participants received palifosfamide-lysine 413 mg/m² by intravenous infusion over approximately 15 minutes on Days 1, 2, and 3 of each 21-day cycle. Forty-nine participants were treated at this dose level. The last 6 participants enrolled also participated in a pharmacokinetic substudy in which they received a single dose of palifosfamide-tris 178 mg/m² on Day -14 before beginning palifosfamide-lysine treatment. |
| Name | Type | Description |
|---|---|---|
| palifosfamide-tris | DRUG | palifosfamide-tris IV infusion of 150 mg/m2 on Days 1, 2 and 3 every three weeks (21 day cycle) |
| Normal Saline | DRUG | 0.9% Normal Saline 250 ml IV infusion on Cycle 1 Day -1 |
| ZIO-201 | DRUG | Palifosfamide-lysine (ZIO-201) was administered by intravenous infusion on Days 1, 2, and 3 of each 21-day cycle. Dose and formulation are specified in the corresponding Arm descriptions. |
Inclusion criteria: 1. Male or female subjects, age ≥ 18 years, who have provided written informed consent prior to completing any study specific procedure. 2. Histologically or cytologically confirmed solid tumor that has progressed following available standard therapies or for which no standard t...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
ZIO-201 is an investigational small molecule developed by Alaunos Therapeutics, Inc. for the treatment of advanced cancer and advanced sarcoma. It has been studied in Phase 1 clinical trials in adult patients with these solid tumors. ZIO-201 remains in clinical development and is not approved for commercial use.
ZIO-201 has been studied in advanced sarcoma as an investigational treatment. A Phase 1 trial, NCT00439686, evaluated ZIO-201 in 54 adult patients with advanced sarcoma in the United States. The study is completed. ZIO-201 is not approved for sarcoma or any other indication.
ZIO-201 is being developed by Alaunos Therapeutics, Inc., which trades under the ticker TCRT. The company sponsored the Phase 1 clinical trials of ZIO-201 in advanced cancer and advanced sarcoma. Alaunos Therapeutics is the developer associated with this asset.
ZIO-201 is in Phase 1 clinical development. It has been evaluated in two completed Phase 1 trials, one in advanced sarcoma and one in advanced cancer. No later-phase trials are recorded. ZIO-201 is investigational and has not been approved by the FDA for any indication.
ZIO-201 has been studied in two completed Phase 1 trials. NCT00439686 evaluated ZIO-201 in 54 adults with advanced sarcoma in the United States. NCT00421135 studied intravenous isophosphoramide mustard, also known as IPM, in 30 adults with advanced cancer. Both trials are completed and enrolled adults aged 18 and older.
Yes. ZIO-201 is also known as isophosphoramide mustard, or IPM. The Phase 1 trial NCT00421135 was titled as a study of intravenous isophosphoramide mustard (IPM) in patients with advanced cancer, and it corresponds to the ZIO-201 program. Both names refer to the same investigational small molecule.