Phase 1 Study of Ipatasertib with Cisplatin and Radiation Therapy for Advanced Head and Neck Cancer

What this Trial Is About

Researchers are evaluating the safety and best dose of ipatasertib combined with chemotherapy and radiation therapy in patients with advanced head and neck squamous cell carcinoma. This phase IIb trial studies whether adding ipatasertib, an AKT inhibitor, to the usual chemo-radiation treatment may improve outcomes by stopping tumor growth and killing cancer cells. The trial also monitors response rates, survival, and long-term swallowing function among participants. Participants receive ipatasertib orally once daily or on specific days depending on the dose level, along with weekly intravenous cisplatin chemotherapy and daily radiation therapy Monday through Friday for 7 weeks. The treatment cycles last 28 days and repeat twice if there is no disease progression or unacceptable toxicity. The study includes a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase using that dose. Imaging scans such as PETCT, CT, or MRI, blood sample collection, and tumor biopsies are performed during screening, treatment, and follow-up. Participants are followed closely with assessments including toxicity evaluations, pharmacokinetic and pharmacodynamic testing, and tumor response measurements up to 2 years after treatment begins. Safety and swallowing function are monitored for up to a year after radiation completion. After finishing treatment, participants have a 30-day follow-up visit and then regular visits every 3 months for up to 2 years. Researchers collect blood samples and tumor biopsies to study drug effects and correlate genetic changes with outcomes.

Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer