Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Eftozanermin alfa
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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ABBV-621 is an investigational small molecule being studied in adults with previously treated advanced solid tumors and hematologic malignancies. It is not approved for any indication. The Phase 1 study enrolled participants with advanced cancers whose tumors had progressed after prior therapy, and it was evaluated for safety and tolerability rather than for a specific approved use.
ABBV-621 is being developed by AbbVie Inc., the biopharmaceutical company that trades on the New York Stock Exchange under the ticker ABBV. AbbVie sponsored the Phase 1 study of ABBV-621 in participants with previously treated solid tumors and hematologic malignancies, which was conducted across sites in the United States, Japan, the Netherlands, and Spain.
ABBV-621 is in Phase 1 clinical development. Its single registered trial, NCT03082209, was a Phase 1 study of safety and tolerability in participants with previously treated solid tumors and hematologic malignancies. That trial is now completed, and ABBV-621 remains an investigational agent that has not been approved by the FDA for any indication.
ABBV-621 has been evaluated in one registered clinical trial, NCT03082209, titled A Study of the Safety and Tolerability of ABBV-621 in Participants With Previously-Treated Solid Tumors and Hematologic Malignancies. The Phase 1 trial enrolled 153 participants aged 18 years and older across the United States, Japan, the Netherlands, and Spain, and its status is completed.
No. ABBV-621 is an investigational drug and has not been approved by the FDA. It has completed a single Phase 1 trial, NCT03082209, which assessed safety and tolerability in 153 participants with previously treated advanced solid tumors and hematologic malignancies. Phase 1 testing is the earliest stage of clinical development, so ABBV-621 remains in clinical research.
The Phase 1 trial of ABBV-621, NCT03082209, was not randomized and was not double blinded. It used a controlled design and enrolled 153 participants with previously treated solid tumors and hematologic malignancies. The study was biomarker selected, meaning participants were chosen based on specific biomarker criteria, and it included sites in the United States, Japan, the Netherlands, and Spain.