Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Sclerosis

Neoplasm Metastasis

Tuberous Sclerosis

Neoplastic Processes

Tuberous Sclerosis Complex

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Sirolimus

Temsirolimus

MTOR Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Immunosuppressive Agents

Immunologic Factors

Patients with pathogenic inactivating TSC1 alterations.

Patients with pathogenic inactivating TSC2 alterations.

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

nab-sirolimus

Aadi Bioscience Medical Information

Tempus

Karla Childers

Sherri Arledge, MD

Erika Arguello Vargas

Allan Espinosa Morazan, MD

Terry Thomas

Lyndsay Willmott, MD

Erika Aruello

Alphea Bonds Castro

David Palchak, MD

Kumar Sankhala, MD

Nazeli Livaskani

Jacob Thomas, MD

Nazanin Kavenhfar

Noah Federman, MD

Jericho Rabago

Michael Demeure, MD

Victoria Chua

Erlinda Maria Gordon, MD

Camille Shaffer

Ian Anderson, MD

Khadija Bedar

Kristen Ganjoo, MD

Omkar Marathe, MD

Jennifer Hege

Patrick Eulitt, MD

Staci Williams

Maen Hussein, MD

Patel Chandni

Magali Van den Bergh, MD

Chandni Patel

Barry S Berman, MD

Chandri Park

Justin Elkins

Gaurav Trikha, MD

Robert Doran

Shanna Kennedy

Kamal Sharma, DO

Chandni Park

Praneetha Achanta

Srilata Gundala, MD

Sunil Babu, MD

Chelsea Formato

Ebenezer Kio, MD

Jenelle Larkin

Mark Goldstein, MD

Ava Greenberg

Candace Haddox, MD

Ola Atchison

Dipesh Uprety, MD

Jinan Ali

Sushma Tatineni

Allie Gordon

Brian A Van Tine, MD

Lauren Murphy

David Crockett, MD

Teresa Ryba

Brent Tierney, MD

Audrey Ades

Jill Morrison, MD

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

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.

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.

ORR based on the proportion of patients with best overall response (BOR) of confirmed partial response (PR) or complete response (CR) from the time of study treatment initiation until disease progression as determined by IRR using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Determined for patients with BOR of confirmed CR or PR (by IRR)

BOR of confirmed CR or PR (either of any duration) or stable disease (SD) following study treatment initiation (by IRR)

Time from first dose of study drug to initial measurement of CR or PR, where CR or PR is subsequently confirmed

Number of months from study treatment initiation to the date of disease progression (by IRR) or death due to any cause

Number of months from study treatment initiation to the date of death due to any cause

Changes from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire v3.0 (EORTC-QOQ-C30) scores

Incidence and severity of treatment-emergent and treatment-related AEs as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

Aadi Bioscience, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)	NCT05103358	Tumor Tumor, Solid Metastasis Metastatic Canc... Cancer Cancer Metastat... Tumors Neoplasms Neoplasm Metast... Solid Tumor Advanced Solid ... Advanced Cancer Malignant Solid... Malignant Solid... Malignant Neopl... Malignant Tumor TSC TSC1 TSC2 Metastatic Soli... Metastatic Neop...	nab-sirolimus	12 Years -	Aadi Bioscience, Inc.
Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)	NCT05103358	Tumor Tumor, Solid Metastasis Metastatic Canc... Cancer Cancer Metastat... Tumors Neoplasms Neoplasm Metast... Solid Tumor Advanced Solid ... Advanced Cancer Malignant Solid... Malignant Solid... Malignant Neopl... Malignant Tumor TSC TSC1 TSC2 Metastatic Soli... Metastatic Neop...	nab-sirolimus	12 Years -	Aadi Bioscience, Inc.

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