P-Sam for Adenoid Cystic Carcinoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called P-Sam (Puxitatug Samrotecan, AZD8205) for adenoid cystic carcinoma, a rare cancer often affecting the head, neck, and salivary glands. The goal is to evaluate the effectiveness and safety of this new treatment for aggressive forms of the cancer. Suitable candidates for this trial have advanced or recurrent/metastatic adenoid cystic carcinoma that cannot be treated with surgery or radiation. Participants should have a specific cancer cell profile with certain genetic changes or low protein levels. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.
Do I need to stop my current medications to join the trial?
The trial requires a 'washout period' (time without taking certain medications) for some treatments before starting the study drug. Specifically, you must stop nitrosourea or mitomycin C 6 weeks before, any investigational agents 5 half-lives or 28 days before, and other anticancer treatments 21 days before the trial. Check with the trial team to see if your current medications fall into these categories.
Is there any evidence suggesting that P-Sam is likely to be safe for humans?
Previous studies have shown that puxitatug samrotecan (P-Sam) has a manageable safety profile, with side effects similar to those of other treatments. Research found that patients tolerated P-Sam well, and most side effects could be managed. While some patients experienced unwanted side effects, they were usually mild or moderate.
P-Sam is still under study to ensure its safety and effectiveness. The current trial phase examines both the treatment's mechanism and safety. Researchers are closely monitoring any side effects and patient responses.12345Why do researchers think this study treatment might be promising?
Most treatments for adenoid cystic carcinoma focus on surgical removal, radiation, and chemotherapy to tackle tumor growth. However, Puxitatug Samrotecan (AZD8205) is unique because it combines a targeted approach with a novel active ingredient. This drug is an antibody-drug conjugate, meaning it links a potent chemotherapy agent to an antibody designed to specifically target cancer cells, potentially minimizing damage to healthy cells. Researchers are excited about this treatment because it offers a more precise mechanism of action, which could lead to better efficacy and fewer side effects compared to conventional treatments.
What evidence suggests that P-Sam might be an effective treatment for adenoid cystic carcinoma?
Research has shown that Puxitatug Samrotecan (P-Sam), the treatment under study in this trial, may help treat certain cancers. In a previous study, about 20.9% of patients with advanced or spreading cancers responded to the drug, meaning roughly one in five patients saw improvement. P-Sam combines a targeted approach with a potent drug to attack cancer cells. Early trials indicate it has a safety profile similar to other drugs of its kind, with manageable side effects. These results suggest P-Sam could be effective for patients with adenoid cystic carcinoma, especially those with specific genetic traits.12467
Who Is on the Research Team?
Renata Ferrarotto, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with an aggressive form of Adenoid Cystic Carcinoma (ACC) that has returned or spread, and whose tumors have specific genetic features like NOTCH mutations or low p63/high B7-H4 levels. Details on who can join are not fully provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive P-Sam at 2.4 mg/kg intravenously on Day 1 of a 21-day treatment cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Puxitatug Samrotecan (AZD8205)
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology