Phase II Study of Puxitatug Samrotecan (AZD8205) for Advanced, Recurrent, or Metastatic Aggressive Adenoid Cystic Carcinoma Subtype I
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT07162480
This clinical trial is testing the effectiveness and safety of a new drug, Puxitatug Samrotecan (P-Sam), in treating patients with a specific type of aggressive adenoid cystic carcinoma that has returned or spread.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to evaluate how well Puxitatug Samrotecan (P-Sam) works and how safe it is for patients with advanced, recurrent, or metastatic adenoid cystic carcinoma subtype I (ACC-I). This includes patients whose cancer has a specific genetic mutation or low levels of a certain protein. Researchers will look at how the drug affects tumor growth, how long patients respond to the treatment, and overall survival rates. They will also assess patients' quality of life during the treatment and explore biological markers that might predict how well the treatment works.
Description
The main goal of this study is to see how well Puxitatug Samrotecan (P-Sam) works in shrinking tumors and how safe it is for patients with advanced, recurrent, or metastatic adenoid cystic carcinoma subtype I (ACC-I). Researchers will also measure how long the treatment keeps the cancer under control, how long patients live without the cancer getting worse, and overall survival rates. They will assess patients' quality of life during the treatment and explore biological markers in tissue and blood that might predict how well the treatment works.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older with confirmed advanced or recurrent/metastatic adenoid cystic carcinoma (ACC).
- Cancer that cannot be removed by surgery or treated with radiation, or has returned or spread.
- Specific subtype of ACC defined by:
- A genetic mutation in the NOTCH gene.
- Cancer that returned or progressed within 3 years of diagnosis or has spread beyond the lungs.
- Low levels of a protein called TP63.
- Measurable cancer according to standard criteria.
- Good overall health with a performance status of 0 or 1.
- Willing to provide informed consent.
- Adequate bone marrow, liver, and kidney function based on recent lab tests.
- Use of effective contraception for participants and their partners during the study and for 8 months after the last dose.
- Can be new to treatment or have had up to 3 previous treatments for recurrent/metastatic disease, with some exceptions for specific prior treatments.
Exclusion Criteria
- Recent treatment with certain cancer therapies or investigational drugs within specified timeframes before starting the study.
- Unresolved side effects from previous treatments, except for certain conditions like hair loss or controlled hormone disorders.
- Active infections, including tuberculosis, COVID-19, hepatitis B or C, or HIV, unless controlled.
- History of lung inflammation requiring steroids or current lung issues.
- Severe lung problems or need for supplemental oxygen.
- History of certain blood disorders or features suggesting such disorders.
- Heart problems, including certain arrhythmias, recent heart attacks, or heart failure.
- Active brain disease, unless treated and stable.
- Serious ongoing illnesses or conditions that could interfere with the study.
- Substance abuse or other medical conditions that increase risk or interfere with participation.
- Recent live vaccines or plans to receive them during the study.
- Pregnant or breastfeeding women, or those planning to become pregnant.
- Dependence on blood transfusions.
- Participation in another clinical study.
- History of other cancers, unless treated and low risk of recurrence.
- Allergies to study drugs or their components.
- Cognitive impairment affecting consent.
- Previous treatment with specific targeted therapies.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.