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Active Not RecruitingNCT05103358

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

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.

Status
Active Not Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Aadi Bioscience, Inc. · Industry
Sex
All
Age
12 Years
Healthy volunteers
Not accepted

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGnab-sirolimusProspective phase 2, open-label, multi-institutional basket trial to determine the efficacy and safety of nab-sirolimus administered by IV infusion to patients

Timeline

Start date
2022-02-15
Primary completion
2024-12-31
Completion
2025-12-31
First posted
2021-11-02
Last updated
2024-06-03

Locations

166 sites across 3 countries: United States, Puerto Rico, South Korea

Regulatory

Source: ClinicalTrials.gov record NCT05103358. Inclusion in this directory is not an endorsement.