Phase II Puxitatug Samrotecan for Advanced Adenoid Cystic Carcinoma

This study is testing a drug called Puxitatug Samrotecan (AZD8205) for people with advanced, recurrent, or metastatic (cancer that has spread) aggressive adenoid cystic carcinoma (ACC-I). You might be able to join if you are 18 or older, have ACC that can't be treated with surgery or radiation, and your cancer has a specific genetic change (a NOTCH mutation). The main goal is to see how safe Puxitatug Samrotecan is and how well it shrinks tumors. Researchers will also look at how long people respond to the treatment and their quality of life. The study plans to enroll 28 participants.

Study design
This is a Phase II, open-label study, meaning both you and your doctors will know you are receiving Puxitatug Samrotecan. It plans to enroll 28 participants.
What's involved
Puxitatug Samrotecan will be given by IV. The study will assess safety and side effects through study completion, which is an average of 1 year.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07162480

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~28 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:P-Sam

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Adverse Events (AEs)
Measured over Through study completion; an average of 1 year
Adenoid Cystic Carcinoma
1 sites across 1 states
Texas1
  • Renata Ferrarotto, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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  • Safety and Adverse Events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0