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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02360345 | Phase I Trial of ONX-0801 Once Weekly or Alternate Weekly | PHASE1 | COMPLETED | 111 | — | — | Sep 1, 2013 | Mar 1, 2021 | Sep 26, 2024 | 1 | United Kingdom |
Establish the maximum tolerated dose of ONX-0801 when given on a weekly or alternate weekly schedule.
Assign causality of each adverse event to ONX-0801 and grading severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
| Arm | Type | Description |
|---|---|---|
| q1week schedule | EXPERIMENTAL | ONX-0801 will be administered over a 1-hour IV infusion on Days 1, 8, 15 and 22 of repeated 28-day treatment cycles. |
| q2week schedule | EXPERIMENTAL | ONX-0801 will be administered over a 1-hour IV infusion on Days 1 and 15 of repeated 28-day treatment cycles. |
| Name | Type | Description |
|---|---|---|
| ONX-0801 | DRUG | - |
Inclusion Criteria: * Patients with histologically or cytologically proven solid tumours (to include Non-Hodgkin's and Hodgkin's lymphoma). Patients must have disease which has failed standard therapy or for whom no standard curative therapy exists. At the dose expansion phase, entry will be limite...
| 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 |