M.D. Anderson Cancer Center
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.
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.
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: a. Presence of an activating NOTCH mutation per in-house or any CLIA-certified or commercially available next-generation sequencing assay b. Solid histology (any amount of solid component) and clinical course characterized by \< 3 years from diagnosis to initial recurrence or progression or de novo metastatic disease wi…
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