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PRECISION 1 is the first prospective, tumor-agnostic trial of nab-sirolimus for patients who are mTOR inhibitor naive and with malignant solid tumors harboring inactivating alterations in TSC1 or TSC2 genes¹

mTOR=mechanistic target of rapamycin; nab=nanoparticle albumin-bound; TSC1=tuberous sclerosis-1; TSC2=tuberous sclerosis-2.

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What is PRECISION 1?

PRECISION 1 is a prospective, phase 2, open-label, tumor-agnostic, multicenter basket trial of nab-sirolimus 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 upstream in the mTOR pathway.^1-3

Enrolled patients (N=~120) will be allocated into 2 treatment arms^1,4:

Arm A (N=~60)includes patients with pathogenic inactivating TSC1 alterations
Arm B (N=~60)includes patients with pathogenic inactivating TSC2 alterations

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 until disease progression.¹

Visit clinicaltrials.gov to see the secondary outcome measures

mTOR=mechanistic target of rapamycin; nab=nanoparticle albumin-bound; TSC1=tuberous sclerosis-1; TSC2=tuberous sclerosis-2.

Are your patients eligible for PRECISION 1?

Since TSC1 and TSC2 inactivating alterations can be detected through next-generation sequencing (NGS) of a tumor tissue biopsy, patients who have already received an NGS report of their tumor profile do not require an additional biopsy to be considered for PRECISION 1.¹

To enroll in PRECISION 1, patients must meet the following requirements^1,4:

12 years old
Naive to mTOR inhibitors
ECOG PS 0 or 1 (or KPS 80)
Centrally confirmed TSC1 or TSC2 pathogenic inactivating alteration
- Evaluated via NGS of tumor tissue derived DNA (not liquid biopsy)
Metastatic or locally advanced solid tumors ineligible for surgery
Measurable disease
Failed standard therapies appropriate for their tumor type

Learn more about eligibility requirements at clinicaltrials.gov

ECOG PS=Eastern Cooperative Oncology Group performance status; KPS=Karnofsky performance status; mTOR=mechanistic target of rapamycin; TSC1=tuberous sclerosis-1; TSC2=tuberous sclerosis-2.

What are TSC1 and TSC2 inactivating alterations?

What are TSC1 and TSC2 inactivating alterations?

TSC1 and TSC2 are tumor suppressor genes upstream in the mTOR pathway. Alterations or deletions in these genes may lead to mTOR overactivation, which prompts uncontrolled cell growth, metabolism, and survival.^2,3,5

Alterations or deletions in TSC1 or TSC2 genes have been identified in multiple tumor types throughout the body, including the^6-8*:

Bladder
Uterus
Ovaries
Breasts
Lungs
Prostate
Colon
Skin
Pancreas

*Based on number of cases in AACR Project Genomics Evidence Neoplasia Information Exchange (GENIE), an international pan-cancer registry of real-world data assembled through data sharing between 19 leading international cancer centers with the goal of improving clinical decision-making.⁸

Currently, there are no drugs specifically approved to treat patients with malignant tumors harboring TSC1 or TSC2 inactivating alterations.^9-13

AACR=American Association for Cancer Research; mTOR=mechanistic target of rapamycin; TSC1=tuberous sclerosis-1; TSC2=tuberous sclerosis-2.

What is nab-sirolimus?

nab-sirolimus is an mTOR inhibitor that uses nanoparticle albumin-bound (nab) technology engineered to preferentially deliver high levels of drug directly to proliferating tumors for patients aged 12 years or older with pathogenic TSC1 or TSC2 inactivating alterations, regardless of tumor type.¹⁴

Based on preclinical data, nab technology enhances tumor penetration and drug accumulation due to the preferential accumulation of albumin in proliferating tumors.¹⁴

PRECISION 1 is the first prospective trial designed specifically for patients with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes.¹

mTOR=mechanistic target of rapamycin; TSC1=tuberous sclerosis-1; TSC2=tuberous sclerosis-2.

About Aadi Bioscience

Aadi Bioscience, Inc. is a biopharmaceutical company developing precision therapies for genetically-defined cancers. Aadi’s primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations such as inactivating alterations in TSC1 or TSC2 genes, where other mTOR inhibitors have not been or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site.

Aadi’s initial focus is the treatment of ultra-rare cancers, including tumor-agnostic TSC1 and TSC2 inactivating alterations in patients aged 12 years or older.

Learn more about Aadi Bioscience

mTOR=mechanistic target of rapamycin; TSC1=tuberous sclerosis-1; TSC2=tuberous sclerosis-2.

How to enroll patients in PRECISION 1

Please contact Aadi Bioscience for more information on PRECISION 1, including how to enroll a patient.

How to enroll patients in PRECISION 1

Please contact Aadi Bioscience for more information on PRECISION 1, including how to enroll a patient.

Contact Aadi Bioscience

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References:

Phase 2 basket trial of nab-sirolimus in patients with solid tumors with pathogenic alterations in TSC1 or TSC2 genes (PRECISION 1). ClinicalTrials.gov Identifier: NCT05103358. Updated November 12, 2021. Accessed February 28, 2022. https://clinicaltrials.gov/ct2/show/NCT05103358?term=NCT05103358&draw=2&rank=1
Hay N, Sonenberg N. Upstream and downstream of mTOR. Genes Dev. 2004;18(16):1926-1945. doi:10.1101/gad.1212704
Saxton RA, Sabatini DM. mTOR Signaling in Growth, Metabolism, and Disease. Cell. 2017;169(2):361-371. doi:10.1016/j.cell.2017.03.035
Data on file. Aadi Bioscience, Inc.; 2022.
Gonzalez-Angulo AM, Meric-Bernstam F, Chawla S, et al. Weekly nab-rapamycin in patients with advanced nonhematologic malignancies: final results of a phase I trial. Clin Cancer Res. 2013;19(19):5474-5484. doi:10.1158/1078-0432.CCR-12-3110
TSC1. My Cancer Genome. Accessed February 28, 2022. https://www.mycancergenome.org/content/gene/tsc1/
TSC2. My Cancer Genome. Accessed February 28, 2022. https://www.mycancergenome.org/content/gene/tsc2/
GENIE. National Cancer Institute. Accessed February 28, 2022. https://gdc.cancer.gov/about-gdc/contributed-genomic-data-cancer-research/genie
TSC1 studies. ClinicalTrials.gov. Accessed February 28, 2022. https://clinicaltrials.gov/ct2/results?cond=tsc1&term=&cntry=&state=&city=&dist=
TSC2 studies. ClinicalTrials.gov. Accessed February 28, 2022. https://clinicaltrials.gov/ct2/results?cond=tsc2&term=&cntry=&state=&city=&dist=
Kim JW, Milowsky MI, Hahn NM, et al. Sapanisertib, a dual mTORC1/2 inhibitor, for TSC1- or TSC2-mutated metastatic urothelial carcinoma (mUC). Meeting abstract presented virtually at: Genitourinary Cancers Symposium; February 11-13, 2021. Accessed February 28, 2022. https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.6_suppl.431
Afinitor. Prescribing information. Novartis Pharmaceuticals Corporation; 2022. Accessed February 28, 2022. https://www.novartis.us/sites/www.novartis.us/files/afinitor.pdf
Zortress. Prescribing information. Novartis Pharmaceuticals Corporation; 2021. Accessed February 28, 2022. https://www.novartis.us/sites/www.novartis.us/files/zortress.pdf
Wagner AJ, Ravi V, Riedel RF, et al. nab-Sirolimus for patients with malignant perivascular epithelioid cell tumors [published online ahead of print, 2021 Oct 12]. J Clin Oncol. 2021;JCO2101728. doi:10.1200/JCO.21.01728