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Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)

Cancer Clinical Trial

Official title:
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 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
Clinical Trial Details
NCT number NCT05103358
Study type Interventional
Source Aadi Bioscience, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date February 15, 2022
Completion date December 31, 2025
View Details
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