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 developed by AbbVie Inc. for the treatment of advanced solid tumors. It is administered intravenously and is being evaluated in a Phase 1 clinical trial in adults with several tumor types, including non-small cell lung cancer, colorectal cancer, pancreatic ductal adenocarcinoma, gastric cancer, and ovarian cancer.
ABBV-253 is being studied for use in adults with advanced solid tumors. The Phase 1 trial enrolls patients with 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. It is investigational and has not been approved for any indication.
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 Phase 1 study evaluating the drug in advanced solid tumors.
ABBV-253 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA for any indication. The single Phase 1 trial is currently listed as not yet recruiting and is designed to enroll 130 adult participants.
ABBV-253 is being evaluated in one Phase 1 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 trial is not yet recruiting, has a planned enrollment of 130, and is controlled without randomization or blinding.
No. The Phase 1 trial of ABBV-253 in advanced solid tumors does not use biomarker selection, so enrollment is not restricted to patients with a specific molecular marker. Participants must be 18 years or older, and the study enrolls all sexes but does not include healthy volunteers.