Do Your Oncology Patients Needing Next Line Treatment Have a TSC1 or TSC2 Mutation?
These Mutations Occur Across Multiple Solid Tumor Types1 and Represent a Potential Target for an Investigational Treatment.
PRECISION 1 is a clinical trial for an investigational mTOR inhibitor in patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes.2
nab-Sirolimus is an mTOR inhibitor that uses nanoparticle albumin-bound (nab) technology engineered to deliver high levels of drug directly to proliferating tumors, which may result in slower tumor growth in patients with TSC1 and TSC2 inactivating alterations.3
The safety and efficacy of nab-sirolimus in this setting has not been established.
mTOR=mechanistic target of rapamycin; nab=nanoparticle albumin-bound; TSC1=tuberous sclerosis 1; TSC2=tuberous sclerosis 2.
PRECISION 1 is a clinical trial investgating nab-sirolimus in cancer patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes.2
The safety and efficacy of nab-sirolimus in this setting has not been established.
PRECISION 1 is a prospective, phase 2, open-label, tumor-agnostic, multicenter basket trial for patients aged 12 years or older with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes, which are tumor suppressor genes and are upstream regulators of mTOR.2,4,5
The primary objective of the study is to determine the overall response rate (ORR) in patients harboring pathogenic inactivating alterations in TSC1 or TSC2 genes.1
mTOR=mechanistic target of rapamycin; nab=nanoparticle albumin-bound; TSC1=tuberous sclerosis-1; TSC2=tuberous sclerosis-2.
The safety and efficacy of nab-sirolimus in patients with tumors harboring TSC1 or TSC2 mutations have not been established.
TSC1 and TSC2 inactivating alterations can be detected through next-generation sequencing (NGS) of tumor tissue or liquid biopsy. Patients who have already received an NGS report of their tumor profile do not require an additional biopsy to be considered for PRECISION 1.2
Key Eligibility Criteria
ECOG PS=Eastern Cooperative Oncology Group performance status; KPS=Karnofsky performance status;
LPPS=Lansky-Play Performance Scale; mTOR=mechanistic target of rapamycin; TSC1=tuberous sclerosis 1; TSC2=tuberous sclerosis 2
The safety and efficacy of nab-sirolimus in patients with tumors harboring TSC1 or TSC2 mutations have not been established.
TSC1 and TSC2 are tumor suppressor genes downstream in the mTOR pathway. Alterations in these genes may resut in mTOR pathway overactivation, which prompts uncontrolled cell growth, metabolic changes, and enhanced survival.4-6
Currently, there are no drugs approved to treat patients with malignant tumors specifically harboring TSC1 or TSC2 inactivating alterations.7-11
Alterations or deletions in TSC1 or TSC2 genes have been identified in multiple tumor types throughout the body, in percentages up to 8%.1
AACR=American Association for Cancer Research; mTOR=mechanistic target of rapamycin; TSC1=tuberous sclerosis-1; TSC2=tuberous sclerosis-2
The safety and efficacy of nab-sirolimus in patients with tumors harboring TSC1 or TSC2 mutations have not been established.
nab-Sirolimus is an mTOR inhibitor that uses nanoparticle albumin-bound (nab) technology. Based on preclinical data, nab technology enhances tumor penetration and drug accumulation due to the preferential accumulation of albumin in proliferating tumors.3 In preclinical studies, this enhanced accumulation resulted in slowed tumor growth.3
The safety and efficacy of nab-sirolimus for the treatment of solid tumors harboring TSC1 or TSC2 mutations has not been established.
mTOR=mechanistic target of rapamycin; TSC1=tuberous sclerosis-1; TSC2=tuberous sclerosis-2.
The safety and efficacy of nab-sirolimus in patients with tumors harboring TSC1 or TSC2 mutations have not been established.
At Aadi Bioscience, our mission is to improve the lives of people with mTOR-driven diseases. We believe success depends on addressing the limitations of current mTOR inhibitors and leveraging the latest genomic profiling technology to identify the patients most likely to benefit from mTOR inhibition
The safety and efficacy of nab-sirolimus in patients with tumors harboring TSC1 or TSC2 mutations have not been established.
Please contact Aadi Bioscience for more information on PRECISION 1, including how to enroll a patient.
Please contact Aadi Bioscience for more information on PRECISION 1, including how to enroll a patient.
Contact Aadi Bioscience
The safety and efficacy of nab-sirolimus in patients with tumors harboring TSC1 or TSC2 mutations have not been established.
For a full listing of all participating locations, please refer to www.clinicaltrials.gov
Requests for information may be submitted by contacting Aadi Bioscience Medical Information via telephone 888-BIO-AADI (888-246-2234) or by sending an email to MedInfo@aadibio.com.
The safety and efficacy of nab-sirolimus in patients with tumors harboring TSC1 or TSC2 mutations have not been established.
References
The safety and efficacy of nab-sirolimus in patients with tumors harboring TSC1 or TSC2 mutations have not been established.