Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-253 · 1 trial · 9 indications
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. Safety will be evaluated based upon the assessment of all-grade AEs, and SAEs reported during the treatment-emergent period, as well as clinical laboratory parameters (e.g., hematology, chemistry), vital sign measurements, and ECG results.
Number of participants with abnormal change in clinical laboratory test results like hematology and chemistry will be assessed.
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
12-lead resting ECG will be recorded.
Objective Response (OR) defined as achieving confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigators.
| Arm | Type | Description |
|---|---|---|
| Part 1: ABBV-253 Dose Escalation | EXPERIMENTAL | Participants with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), pancreatic ductal adenocarcinoma cancer (PDAC), gastroesophageal adenocarcinoma (GEA), biliary tract cancer (BTC) and ovarian cancer (OC) will receive escalating doses of ABBV-253 monotherapy. |
| Part 2: Dose Optimization - ABBV-253 Dose A | EXPERIMENTAL | Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose A. |
| Part 2: Dose Optimization - ABBV-253 Dose B | EXPERIMENTAL | Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose B. |
| Part 2: Dose Optimization - ABBV-253 Dose C | EXPERIMENTAL | Participants with NSCLC EGFR WT participants will receive ABBV-253 monotherapy Dose C. |
| Name | Type | Description |
|---|---|---|
| ABBV-253 | DRUG | Infusion |
Inclusion Criteria: * Part 1 monotherapy dose escalation only: Participants with a diagnosis of a malignant solid tumor by histology (WHO criteria), including, but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), PDAC, gastro...
| 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-253 is an investigational small molecule being studied in adults with advanced solid tumors. The Phase 1 trial enrolls patients with several tumor types, including non-small cell lung cancer, colorectal cancer, pancreatic ductal adenocarcinoma, gastric cancer, gastroesophageal junction adenocarcinoma, biliary tract cancer, head and neck squamous cell carcinoma, and ovarian cancer.
ABBV-253 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the compound in advanced solid tumors.
ABBV-253 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The single registered trial is a Phase 1 study that is currently recruiting participants.
ABBV-253 is being evaluated in trial NCT07807956, titled A Study to Assess Adverse Events, Change in Disease Activity and How Intravenous ABBV-253 Moves Through the Body in Adult Participants With Advanced Solid Tumors. The Phase 1 study is recruiting up to 130 participants aged 18 and older across sites in the United States.
ABBV-253 is administered intravenously in its Phase 1 study, NCT07807956. The trial assesses adverse events, changes in disease activity, and how the drug moves through the body in adult participants with advanced solid tumors. It is a controlled study that is not randomized and not double blinded, and it does not select patients by biomarker.