NCT07162480

Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Carcinoma Subtype I (ACC-I)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Adenoid Cystic Carcinoma

Interventions

Type	Name	Description
DRUG	P-Sam	Given by IV

Timeline

• Start date: 2026-12-28
• Primary completion: 2029-12-31
• Completion: 2031-12-31
• First posted: 2025-09-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study