Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-165 · 1 trial · 1 indication
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 |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ABT-165 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.
ABT-165 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical research to evaluate the drug's potential in treating advanced solid tumors.
ABT-165 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of advanced solid tumors, and its safety and efficacy have not yet been established.
ABT-165 has been studied in one clinical trial, identified as NCT01946074, titled 'A Study of ABT-165 in Subjects With Solid Tumors.' This Phase 1 trial was completed and enrolled 101 participants with advanced solid tumors. The study was conducted in the United States.
No, ABT-165 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for advanced solid tumors. The drug has not completed the clinical trial process required for regulatory approval, and its safety and effectiveness have not been confirmed.