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 | 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 |