Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00942799 | Dose Escalation Study to Assess the Safety and Tolerability of Genz-644282 in Patients With Solid Tumors | PHASE1 | COMPLETED | 87 | — | — | Jul 1, 2009 | Jan 1, 2013 | Mar 19, 2014 | 4 | United States |
| 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 | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |