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ASG-5ME · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | ASG-5ME |
| Name | Type | Description |
|---|---|---|
| ASG-5ME | DRUG | 0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles |
Inclusion Criteria: * Pathologically confirmed metastatic pancreatic adenocarcinoma or pathologically confirmed AGS-5-positive gastric or gastric esophageal junction adenocarcinoma * Measurable disease (at least one nonresectable, non-nodal lesion greater than or equal to 10 mm in longest diameter ...
ASG-5ME is an investigational therapy being studied for gastric neoplasms, including gastric adenocarcinoma, and for pancreatic adenocarcinoma. It has been evaluated in a Phase 1 dose escalation trial in patients with these tumor types. It is not approved for any indication and remains in clinical development.
ASG-5ME targets SLC44A4 and several tubulin proteins, including TUBB4B, TUBB1, TUBA3C, TUBA4A, and TUBB3. SLC44A4 is a cell surface antigen, while the tubulin targets are components of the microtubule cytoskeleton. The drug is classified as a binding agent.
ASG-5ME is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor responsible for the clinical program evaluating the agent in gastric and pancreatic cancers.
ASG-5ME is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials at this time. The drug is investigational and has not been approved by the FDA for any indication.
ASG-5ME has been studied in a single Phase 1 trial, NCT01166490, titled A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric Adenocarcinoma. The trial enrolled 51 patients in the United States and is now completed. It was an uncontrolled, non-randomized study.