Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
P-Sam · 1 trial · 1 indication
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
| Arm | Type | Description |
|---|---|---|
| P-Sam | EXPERIMENTAL | Participants will receive P-Sam at 2.4 mg/kg intravenously on D1 of a 21-day treatment cycle |
| Name | Type | Description |
|---|---|---|
| P-Sam | DRUG | Given by IV |
Inclusion Criteria: 1. Patients ≥18 years with histology-proven advanced, or R/M ACC. 2. Evidence of locally advanced disease not amenable to curative intent surgery or radiotherapy, or recurrent/metastatic disease 3. ACC-I subtype defined by at least one of the following: 1. Presence of an act...
P-Sam is an investigational small molecule oncology drug being developed by AstraZeneca PLC under the ticker AZN. It is in Phase 2 clinical development for adenoid cystic carcinoma, a rare cancer. P-Sam has not been approved by the FDA and remains in clinical testing.
P-Sam is being studied for the treatment of advanced, recurrent or metastatic aggressive adenoid cystic carcinoma subtype I, abbreviated ACC-I. The Phase 2 trial enrolls adults 18 years and older with this rare salivary gland cancer. P-Sam is investigational and is not approved for any use.
AstraZeneca PLC, which trades under the ticker AZN, is developing P-Sam. The company is running the clinical program for this small molecule oncology candidate in adenoid cystic carcinoma. AstraZeneca is the sole developer named for the asset.
P-Sam is in Phase 2 clinical development. One Phase 2 trial is currently recruiting, and no trials for P-Sam have been completed. The drug is investigational and has not received FDA approval. Its development is focused on adenoid cystic carcinoma.
P-Sam is being evaluated in the Phase 2 trial NCT07162480, titled a Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic Aggressive Adenoid Cystic Carcinoma Subtype I. The trial is recruiting in the United States with a planned enrollment of 28 participants. It is an uncontrolled study open to all sexes.
Yes. P-Sam is also known as puxitatug samrotecan and by the code AZD8205. The Phase 2 trial NCT07162480 lists the drug under both the P-Sam and AZD8205 names, so searches for either term refer to the same AstraZeneca investigational small molecule.