Phase II Study Evaluating Targeted Anti-Cancer Treatments for Advanced or Metastatic Tumors with Specific Molecular Alterations

What this Trial Is About

Researchers are evaluating the effectiveness and safety of various matched targeted therapies MTTs in patients with advanced or metastatic cancers. This phase II, multicenter, open-label study uses a sequential Bayesian design to assign patients to treatment cohorts based on specific molecular alterations found in tumor samples from either the primary tumor or metastatic lesions. The study allows flexibility to open or close treatment cohorts depending on their clinical benefit, aiming to provide targeted treatment options for patients resistant to or lacking standard therapies. Participants receive one of several study drugs tailored to their tumors molecular characteristics. These include HDM201 with Ribociclib, Cabozantinib, Alectinib, Regorafenib, Trametinib alone or combined with Dabrafenib, and Avapritinib. Each drug is administered orally with specific dosing schedules, such as continuous daily dosing or cycles with treatment and break periods. Patients continue treatment as long as clinical benefit is observed or until unacceptable side effects, disease progression, or withdrawal of consent. Some patients may continue treatment even after disease progression if certain clinical criteria are met. During the study, participants undergo regular assessments including radiographic evaluations and clinical status checks to monitor treatment response, measured primarily by progression-free rate at 12 weeks. Secondary outcomes include objective response rate, duration of response, progression-free survival, overall survival, and adverse events over up to three years. Patients must comply with study procedures and are monitored closely for safety and effectiveness throughout their participation, which may last until disease progression or other study endpoints.

A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.