Actively Recruiting
Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Carcinoma Subtype I (ACC-I)
Led by M.D. Anderson Cancer Center · Updated on 2026-05-04
28
Participants Needed
1
Research Sites
296 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Carcinoma Subtype I (ACC-I)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older with confirmed advanced or recurrent/metastatic Adenoid Cystic Carcinoma (ACC)
- Locally advanced disease not suitable for surgery or radiotherapy, or recurrent/metastatic disease
- ACC-I subtype defined by activating NOTCH mutation, or solid histology with rapid progression, or low TP63 tumor expression (<10%)
- Measurable disease by RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Provided informed consent
- Adequate bone marrow, liver, and kidney function
- Use of contraception consistent with local regulations during and after study
- Treatment-naive or up to 3 prior systemic therapies for recurrent/metastatic disease, with no more than two prior chemotherapy or antibody-drug conjugate regimens (except prior B7-H4-targeting ADC or topoisomerase inhibitors)
You will not qualify if you...
- Recent treatment with nitrosourea or mitomycin C within 6 weeks before study drug
- Use of investigational agents within 5 half-lives or 28 days before study drug
- Other anticancer treatments within specified washout periods (cytotoxic: 21 days; biologics: 28 days; radiotherapy: 14-28 days)
- Unresolved Grade 2 or higher toxicities from prior therapies (except certain controlled conditions)
- Active infections including tuberculosis, SARS-CoV-2, hepatitis B or C, or HIV
- History or current interstitial lung disease or pneumonitis requiring steroids
- Severe pulmonary disease or need for supplemental oxygen
- History or features of myelodysplastic syndrome or acute myeloid leukemia
- Significant cardiac conditions including arrhythmias, uncontrolled hypertension, recent myocardial infarction, stroke, symptomatic heart failure, cardiomyopathy, or prolonged QT interval
- Active central nervous system disease
- Uncontrolled illnesses or psychiatric/social conditions limiting compliance
- Substance abuse or medical conditions increasing safety risk
- Receipt of live attenuated vaccine within 30 days before study drug
- Pregnant, breastfeeding, or planning pregnancy during study
- Dependence on red blood cell transfusions exceeding two units in 4 weeks before screening
- Current participation in another interventional clinical study
- History of previous malignancy with exceptions for certain low-risk cancers treated with curative intent
- Known allergy to study drug or components
- Cognitive impairment preventing informed consent
- Prior exposure to B7-H4 targeting ADC or topoisomerase inhibitor therapies with that mode of action
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Renata Ferrarotto, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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