Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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

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.

Details

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.

Keywords

Tumor, Tumor, Solid, Metastasis, Metastatic Cancer, Cancer, Cancer Metastatic, Tumors, Neoplasms, Neoplasm Metastasis, Solid Tumor, Advanced Solid Tumor, Advanced Cancer, Malignant Solid Tumor, Malignant Solid Neoplasm, Malignant Neoplasm, Malignant Tumor, TSC, TSC1, TSC2, Metastatic Solid Tumor, Metastatic Neoplasm, TSC1 gene, TSC2 gene, Tissue agnostic, Basket, nab-sirolimus, mTOR inhibitor, nanoparticle albumin bound, mammalian target of rapamycin, mechanistic target of rapamycin, tumor profile, tuberous sclerosis complex 1, tuberous sclerosis complex 2, mTOR, sirolimus, ABI-009, FYARRO, Precision, Precision 1, Pathogenic alterations, Pathogenic mutations, Inactivating mutations, Pathogenic inactivating TSC1 alterations, Pathogenic inactivating TSC2 alterations

Eligibility

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco California 94115 United States
  • Stanford Cancer Center
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aadi Bioscience, Inc.
ID
NCT05103358
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated