clinical trial · NCT07162480
Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Carcinoma Subtype I (ACC-I)
M.D. Anderson Cancer Center·phase2·not yet recruiting·n = 28
Adenoid Cystic CarcinomaP-Sam
brief summary
Phase II open label study designed to evaluate the efficacy and safety of P-Sam in patients with aggressive, solid, NOTCH mutant or p63 low (B7-H4 high) R/M ACC-I patients.
started
Dec 28, 2026
primary completion
Dec 31, 2029
completion
Dec 31, 2031
last updated
Mar 9, 2026
detailed description
Primary Objective:
To assess the objective response rate and safety of P-Sam in patients with R/M ACC-I.
Secondary Objectives:
To estimate the disease control rate (DCR) To estimate the median duration of response (DOR) To estimate the median progression-free survival (PFS) To estimate the PFS rate at 3 and 6 months To estimate the median overall survival (OS) To assess patient's quality of life (QoL) during P-Sam therapy
Tertiary/Exploratory Objectives:
To explore tissue and blood-based biomarkers that may predict response to therapy.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol