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Also known as Genz-644282 (28-day dosing schedule)
Genz-644282 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Study Drug: Genz-644282 (28-day dosing schedule) | EXPERIMENTAL | Genz-644282 (Each cohort will be based on dose-escalation) |
| Study Drug: Genz-644282 (21-day dosing schedule) | EXPERIMENTAL | Genz-644282 (Each cohort will be based on dose-escalation) |
| Name | Type | Description |
|---|---|---|
| Genz-644282 (28-day dosing schedule) | DRUG | Genz-644282 will be administered as a 60-minute IV infusion. The initial dose of Genz-644282 will be 0.5 mg/m2 and will be administered once weekly for 3 consecutive weeks on Day 1, Day 8, and Day 15 of the 28 day cycle. Each 28-day period will represent one treatment cycle. Study drug will continue to be given until disease progression or unacceptable toxicity is observed. |
| Genz-644282 (21-day dosing schedule) | DRUG | The starting dose of Genz-644282 for the 21-day schedule will be prescriptive and will be based on review of available safety data from the 28-day dosing schedule by the Investigator and Sponsor. Patients will receive Genz-644282 once-weekly for 2 consecutive weeks on Day 1 and Day 8 of a 21 day cycle. Each 21-day period will represent 1 treatment cycle. Patients enrolled in subsequent cohorts will receive higher doses until the MTD is established. |
Inclusion Criteria: * Signed written informed consent * Patients enrolled in dose-escalation phase: Histologically or cytologically confirmed advanced malignant solid tumor for which no standard therapeutic option exists. * For the disease indications evaluated in the expansion phase, the following...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Genz-644282 is an investigational small molecule being studied for the treatment of solid tumors. It was evaluated in a Phase 1 dose escalation study in adult patients with solid tumors. It is not an approved therapy and remains in clinical development.
Genz-644282 is being developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi sponsored the Phase 1 dose escalation study of the compound in patients with solid tumors.
Genz-644282 is in Phase 1 clinical development. Its only recorded trial was a Phase 1 dose escalation study in patients with solid tumors, and that study is now completed. The drug is investigational and has not been approved for any indication.
Genz-644282 was studied in one clinical trial, NCT00942799, titled a dose escalation study to assess the safety and tolerability of Genz-644282 in patients with solid tumors. The Phase 1 trial enrolled 87 patients in the United States and is completed.
Yes. Genz-644282 (28-day dosing schedule) is another name used for Genz-644282, referring to the same investigational compound. The 28-day dosing schedule describes how the drug was administered during its Phase 1 dose escalation study in solid tumors.