Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-621 · 1 trial · 3 indications
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 |
| 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 |
ABBV-621 is an investigational small molecule being studied for the treatment of advanced solid tumors and hematologic malignancies. It is intended for participants with previously-treated solid tumors and blood cancers. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
ABBV-621 is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential to treat advanced solid tumors and hematologic malignancies, though the exact mechanism of action is not publicly detailed.
ABBV-621 is being developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol ABBV. AbbVie is conducting clinical trials to evaluate the safety and tolerability of this investigational drug in patients with previously-treated solid tumors and hematologic malignancies.
ABBV-621 is in Phase 1 clinical development. The drug is investigational and has not been approved by the FDA or other regulatory agencies. It is currently being studied in a completed Phase 1 trial to assess its safety and tolerability in participants with advanced solid tumors and hematologic malignancies.
ABBV-621 has been studied in one clinical trial, identified as NCT03082209. This Phase 1 study, titled 'A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies,' enrolled 153 participants and has been completed. The trial was conducted in the United States, Japan, Netherlands, and Spain.
ABBV-621 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A completed Phase 1 trial has evaluated its safety and tolerability, but the drug has not yet received regulatory approval for any indication.