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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01946074 | A Study of ABT-165 in Subjects With Solid Tumors | PHASE1 | COMPLETED | 101 | — | — | Aug 8, 2013 | Sep 28, 2022 | Dec 15, 2023 | 10 | United States |
Hematology, Chemistry, and Urinalysis
Electrocardiogram (ECG), echocardiogram (ECHO), basic natriuretic peptide (BNP) and troponin I
AUC (0-t) = Area under the serum concentration versus time curve form time zero (pre-dose) to the time of the last measurable concentration
Assessment of normal/abnormal physical findings
Collect all adverse events at each visit
Blood pressure, heart rate, respiratory rate and body temperature
| Arm | Type | Description |
|---|---|---|
| Monotherapy | EXPERIMENTAL | ABT-165 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle). Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-165 |
| Cohort A | EXPERIMENTAL | ABT-165 plus paclitaxel |
| Cohort B | EXPERIMENTAL | ABT-165 plus FOLFIRI |
| Cohort C | EXPERIMENTAL | ABT-165 plus ABBV-181 |
| Cohort D | EXPERIMENTAL | ABT-165 plus ABBV-181 plus paclitaxel |
| Name | Type | Description |
|---|---|---|
| paclitaxel | DRUG | Paclitaxel will be administered by intravenous infusion. |
| FOLFIRI | DRUG | 5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion. |
| ABT-165 | DRUG | ABT-165 will be administered by intravenous infusion at escalating dose levels. |
| ABBV-181 | DRUG | ABBV-181 will be administered by intravenous infusion. |
Inclusion Criteria: * Subject must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit. * Subject has adequate bone marrow, renal, hepatic and coagulation function. * Subject must have measurable disease ...
| 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 |