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Clinical Trial Summary

A Phase 2 multi-center open-label basket trial of nab-sirolimus for adult and adolescent patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes


Clinical Trial Description

Study TSC-007 is a prospective phase 2, open-label, multi-institutional basket trial to determine the efficacy and safety profile of nab-sirolimus administered to patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. Patients will be treated with single agent IV nab-sirolimus until disease progression, or unacceptable toxicity, or until in the opinion of the investigator the patient is no longer benefiting from therapy, or at patient discretion. ;


Study Design


Related Conditions & MeSH terms

  • Advanced Cancer
  • Advanced Solid Tumor
  • Cancer
  • Cancer Metastatic
  • Malignant Neoplasm
  • Malignant Solid Neoplasm
  • Malignant Solid Tumor
  • Malignant Tumor
  • Metastasis
  • Metastatic Cancer
  • Metastatic Neoplasm
  • Metastatic Solid Tumor
  • Neoplasm Metastasis
  • Neoplasms
  • Solid Tumor
  • TSC
  • TSC1
  • TSC2
  • Tumor
  • Tumor, Solid
  • Tumors

NCT number NCT05103358
Study type Interventional
Source Aadi Bioscience, Inc.
Contact Aadi Bioscience Medical Information
Phone 1-888-246-2234
Email MedInfo@aadibio.com
Status Recruiting
Phase Phase 2
Start date February 15, 2022
Completion date December 31, 2025

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