West Cancer Center

ADVANCED SOLID TUMORS: METASTATIC: TSC1/TSC2 alterations: last line: 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.

VIEW TRIAL ON CLINICALTRIALS.GOV

Malignancy

Breast, lung, colon, prostate, bladder, RCC, kidney, skin, melanoma, gastric, pancreatic, HCC, rectal, sarcoma, head and neck, esophagus, biliary tract

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Last line

Investigational Agent

nab-sirolimus

Drug Class

MTOR inhibitor

Dan Vaena, MD

Sponsor

Aadi Bioscience, Inc.

Path

TSC1 or TSC2 alterations

Key Eligibility Criteria Details

Malignant solid tumor with pathogenic inactivating TSC1 or TSC2 alterations. GEnetic alterations should be identified using NGS in tumor tissue or liquid biopsy
Metastatic or locally advanced solid tumors
Must have received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the investigator, the patient would b e unlikely to tolerate or derive clinically meaningful benefit from appropriate SOC therapy
Measurable disease
ECOG PS 0-1
Fasting tryglecerid must be < or = 300; fast serus cholesterol must be < or = to 350
No prior treatment with MTOR inhibitor
No primary brain tumors
No known HIV