Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-155 · 1 trial · 1 indication
The Maximum Tolerated Dose (MTD) and/or the Recommended Phase Two Dose (RPTD) of ABBV-155 will be determined during the dose escalation phase (Part 1).
ORR is defined as the percentage of participants with documented best response partial response (PR) or better according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
| Arm | Type | Description |
|---|---|---|
| Escalation 1a: ABBV-155 | EXPERIMENTAL | Participants will be administered ABBV-155 (various doses). |
| Escalation 1b: ABBV-155 + paclitaxel or docetaxel | EXPERIMENTAL | Participants will be administered ABBV-155 (various doses) in combination with paclitaxel or docetaxel . |
| Expansion 2a: ABBV-155 in SCLC | EXPERIMENTAL | Description: Participants with small cell lung cancer (SCLC) will administer ABBV-155 (at the recommended Phase 2 dose). |
| Expansion 2b: ABBV-155 + paclitaxel in Breast Cancer | EXPERIMENTAL | Participants with breast cancer will be administered ABBV-155 (at the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with paclitaxel. |
| Expansion 2b: ABBV-155 + docetaxel in NSCLC | EXPERIMENTAL | Participants with non-small cell lung cancer (NSCLC) will be administered ABBV-155 (at or near the recommended Phase 2 dose identified for combination with paclitaxel in part 1b) in combination with docetaxel. |
| Name | Type | Description |
|---|---|---|
| ABBV-155 | DRUG | Intravenous (IV) Infusion |
| Paclitaxel | DRUG | Intravenous (IV) Infusion |
| Docetaxel | DRUG | Intravenous (IV) Infusion |
Inclusion Criteria: * Has a histologic or cytologic diagnosis of a malignant solid tumor. * Participants enrolled in Part 2a (monotherapy, dose expansion) must have small cell lung cancer (SCLC) diagnosis; participants enrolled to Part 2b (combination therapy, dose expansion) must have either NSCLC...
| 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-155 is an investigational small molecule developed by AbbVie Inc. (ticker ABBV) for advanced solid tumors. It is a Phase 1 oncology candidate that targets BCL-xL and was studied both as a single agent and in combination with taxane therapy in adults with relapsed and/or refractory solid tumors.
ABBV-155 is being studied for the treatment of advanced solid tumors, specifically in adults with relapsed and/or refractory disease. It is an investigational therapy and has not been approved for any indication. The clinical program enrolled patients with advanced solid tumors across multiple countries.
ABBV-155 targets BCL-xL, a protein in the BCL-2 family that regulates apoptosis, or programmed cell death. By inhibiting BCL-xL, the drug is designed to promote cell death in tumor cells. The Phase 1 study was biomarker selected, meaning patients were screened for relevant biomarkers before enrollment.
ABBV-155 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie sponsored the Phase 1 clinical trial evaluating the drug alone and in combination with taxane therapy in adults with relapsed and/or refractory solid tumors.
ABBV-155 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The single Phase 1 trial has been completed, and no active trials are currently listed for this asset.
ABBV-155 was evaluated in one Phase 1 trial, NCT03595059, titled A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors. The trial enrolled 168 patients across the United States, Australia, Canada, Israel, Japan, the Netherlands, Puerto Rico, South Korea, Spain, and Taiwan, and it is now completed.