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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03834948 | AO-176 in Multiple Solid Tumor Malignancies | PHASE1 | COMPLETED | 57 | — | — | Feb 4, 2019 | Feb 15, 2023 | Aug 22, 2023 | 10 | United States |
Evaluate the safety of AO-176 measured by the number adverse events, serious adverse events and lab abnormalities.
Evaluate the safety of AO-176 in combination with paclitaxel measured by the number adverse events, serious adverse events and lab abnormalities.
Evaluate the safety of AO-176 in combination with pembrolizumab measured by the number adverse events, serious adverse events and lab abnormalities.
| Arm | Type | Description |
|---|---|---|
| AO-176 Dose Escalation | EXPERIMENTAL | Each dose escalation cohort will initially recruit 3 patients to receive AO-176 in a standard 3+3 design; cohorts will be expanded in the event of a DLT. |
| AO-176 Dose Expansion | EXPERIMENTAL | Once the MTD/RP2D has been established, tumor-specific dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efficacy of AO-176. |
| AO-176 + Paclitaxel Dose Escalation | EXPERIMENTAL | Each dose escalation cohort will initially recruit 3 patients to receive AO-176 and paclitaxel in a standard 3+3 design; cohorts will be expanded in the event of a DLT. |
| AO-176 + Paclitaxel Dose Expansion | EXPERIMENTAL | Once the MTD/RP2D has been established, tumor-specific dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efficacy of AO-176 + paclitaxel. |
| AO-176 + Pembrolizumab Dose Escalation | EXPERIMENTAL | Each dose escalation cohort will initially recruit 3 patients to receive AO-176 and pembrolizumab in a standard 3+3 design; cohorts will be expanded in the event of a DLT. |
| AO-176 + Pembrolizumab Dose Expansion | EXPERIMENTAL | Once the MTD/RP2D has been established, tumor-specific dose expansion cohorts will be recruited to further assess safety and evaluate preliminary efficacy of AO-176 + pembrolizumab. |
| Name | Type | Description |
|---|---|---|
| AO-176 | DRUG | Humanized monoclonal antibody (mAb) targeting CD47 |
| AO-176 + Paclitaxel | DRUG | Humanized monoclonal antibody (mAb) targeting CD47 and paclitaxel |
| AO-176 + Pembrolizumab | DRUG | Humanized monoclonal antibody (mAb) targeting CD47 and pembrolizumab |
Key Inclusion Criteria 1. Select advanced solid tumor for which standard therapy proven to provide clinical benefit does not exist, or is no longer effective Part A: * Epithelial ovarian carcinoma (EOC) * Endometrial carcinoma * Castration resistant prostate cancer * Non-small cell ...
| 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 |