Study of Trastuzumab Deruxtecan Combined With Azenosertib to Treat Advanced or Metastatic HER2-Positive Gastric and Other Solid Tumors

What this Trial Is About

Researchers are investigating the combination of two anticancer drugs, azenosertib and trastuzumab deruxtecan, in patients with HER2-positive gastric, gastroesophageal junction, or other solid tumors that are locally advanced, metastatic, or cannot be removed by surgery. This phase I trial aims to evaluate the safety, side effects, and best dose of this combination treatment, and to observe its antitumor activity and effects on tumor biology. The study is sponsored by the National Cancer Institute and focuses on tumors that express or amplify HER2. Participants receive trastuzumab deruxtecan intravenously on day 1 of each 21-day cycle, combined with oral azenosertib administered on various day schedules within each cycle. The study includes a dose-escalation phase followed by a dose-expansion phase with two patient cohorts receiving slightly different dosing schedules. Throughout the trial, participants undergo regular imaging tests such as CT or MRI, heart function tests ECHO or MUGA, blood sample collections, and biopsies at screening and during treatment. During the study, participants are closely monitored for safety and treatment effects with assessments including laboratory tests and imaging at baseline and throughout treatment. After completing study treatment, patients have a follow-up visit at 30 days, then every three months during the first two years, and every six months in the third year. The research team measures outcomes like maximum tolerated dose, dose-limiting toxicities, adverse events, response rates, progression-free survival, and duration of response to better understand the combinations impact over up to three years.

Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors