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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03082209 | A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies | PHASE1 | COMPLETED | 153 | — | — | Mar 20, 2017 | Jan 21, 2022 | Dec 9, 2022 | 19 | United States, Japan +2 |
The MTD and/or RP2D of ABBV-621 will be determined during the dose escalation phase of the study of ABBV-621
Area under the serum/plasma concentration time curve (AUC) of ABBV-621.
Area under the serum/plasma concentration time curve (AUC) of venetoclax.
Maximum observed serum concentration (Cmax) of ABBV-621.
Maximum observed serum concentration (Cmax) of venetoclax.
Time to Cmax (Tmax) of ABBV-621.
Time to Cmax (Tmax) of ventoclax.
Terminal phase elimination rate constant (β) for ABBV-621.
Terminal phase elimination rate constant (β) for venetoclax.
Terminal phase elimination half-life (t1/2) for ABBV-621.
Terminal phase elimination half-life (t1/2) for venetoclax.
| Arm | Type | Description |
|---|---|---|
| Chemotherapy combination: ABBV-621 + FOLFIRI + Bevacizumab | EXPERIMENTAL | Participants with KRAS-mutant CRC are administered with ABBV-621 in combination with bevacizumab plus FOLFIRI |
| Chemotherapy combination: ABBV-621+FOLFIRI | EXPERIMENTAL | Participants with RAS-mutant CRC who have received one prior line of therapy will be administered ABBV-621 in combination FOLFIRI. |
| Dose Optimization: ABBV-621 + Venetoclax for AML | EXPERIMENTAL | Additional participants with AML will be enrolled and will be treated with a combination of ABBV-621 and venetoclax. |
| Dose Optimization: ABBV-621 Monotherapy for AML | EXPERIMENTAL | Participants with Acute Myeloid Leukemia (AML) will be treated with ABBV-621 monotherapy. |
| Dose Optimization: ABBV-621 + Venetoclax for DLBCL | EXPERIMENTAL | Participants with diffuse large B-cell lymphoma (DLBCL) will be treated with a combination of ABBV-621 and venetoclax. |
| Dose Optimization for Pancreatic Cancer | EXPERIMENTAL | Participants with pancreatic cancer will be treated with single-agent ABBV-621 to enable selection of the recommended Phase 2 dose (RP2D). |
| Dose Optimization for KRAS-mutant CRC | EXPERIMENTAL | Participants with colorectal cancer (CRC) will be treated with single-agent ABBV-621 to enable selection of the RP2D. |
| Dose Escalation | EXPERIMENTAL | ABBV-621 via intravenous administration at escalating dose levels in participants with solid tumors including Non-Hodgkin Lymphoma (NHL). |
| Name | Type | Description |
|---|---|---|
| ABBV-621 | DRUG | Intravenous (IV) |
| Venetoclax | DRUG | tablet, oral |
| Bevacizumab | DRUG | IV infusion |
| FOLFIRI | DRUG | IV infusion |
Inclusion Criteria: * Must have a diagnosis of a solid tumor (except primary brain tumors), acute myeloid leukemia (AML), or non-Hodgkin lymphoma (NHL); NHL may be of any subtype for Dose Escalation but is limited to diffuse large B-cell lymphoma (DLBCL) for those enrolled to the cohort evaluating ...
| 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 |