Next-Generation Sequencing-Guided Therapy for Advanced Cancers

Next-Generation Sequencing-Guided Therapy for Advanced Cancers

NGS-guided therapy trial for advanced cancers. Phase II basket study using comprehensive genomic profiling to match patients with targeted treatments.

Phase II Basket Study of Next-Generation Sequencing-Guided Targeted Therapy in Advanced Solid Tumors

Full Title

A phase II, open-label, multi-cohort basket study evaluating the efficacy of comprehensive genomic profiling-guided targeted therapy in patients with advanced solid tumors harboring actionable mutations

Purpose

This study uses advanced genetic testing to analyze your tumor’s complete DNA profile and match you with targeted therapies that specifically attack your cancer’s genetic weaknesses. The “basket” design allows patients with different cancer types but similar genetic changes to receive the same targeted treatment.

Primary Objectives

  • Evaluate overall response rate to NGS-guided targeted therapy across multiple tumor types
  • Assess the feasibility of real-time comprehensive genomic profiling for treatment selection
  • Determine progression-free survival for matched targeted therapy

Diseases

Who Can Join this Trial

To participate in this study, you must meet ALL of the following criteria

 

  • Have histologically confirmed advanced or metastatic solid tumor cancer
  • Have sufficient tumor tissue available for comprehensive genomic sequencing and neoantigen identification
  • Have received at least one prior line of standard systemic therapy for advanced disease
  • Have at least one measurable lesion according to RECIST v1.1 criteria
  • ECOG performance status of 0-1
  • Age 18 years or older
  • Life expectancy of at least 12 weeks
  • Adequate organ function including normal blood counts and liver/kidney function
  • Recovered from acute toxicities of prior therapy to grade 1 or baseline