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Aadi Biosciences

🇺🇸United States
Ownership
Public
Employees
89
Market Cap
$41.3M
Website
http://www.aadibio.com

Clinical Trials

11

Active:1
Completed:5

Trial Phases

2 Phases

Phase 1:4
Phase 2:6

Drug Approvals

1

FDA:1

Drug Approvals

FYARRO

Approval Date
Dec 6, 2021
FDA

Clinical Trials

Distribution across different clinical trial phases (10 trials with phase data)• Click on a phase to view related trials

Phase 2
6 (60.0%)
Phase 1
4 (40.0%)

Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer

Phase 2
Recruiting
Conditions
Cancer
Tumor
Endometrioid Tumor
Endometrial Cancer
Recurrent Endometrial Carcinoma
Endometrioid Endometrial Cancer
Interventions
Drug: nab-sirolimus
First Posted Date
2023-08-18
Last Posted Date
2024-05-21
Lead Sponsor
Aadi Bioscience, Inc.
Target Recruit Count
29
Registration Number
NCT05997017
Locations
🇺🇸

Michael Birrer, MD, PhD, Little Rock, Arkansas, United States

🇺🇸

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States

🇺🇸

Women's Cancer Center of Nevada, Las Vegas, Nevada, United States

and more 6 locations

Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors

Phase 2
Recruiting
Conditions
Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumor
Pulmonary Neuroendocrine Tumor
NET
Gastrointestinal Neuroendocrine Tumor
Interventions
Drug: nab-sirolimus
First Posted Date
2023-08-18
Last Posted Date
2024-07-16
Lead Sponsor
Aadi Bioscience, Inc.
Target Recruit Count
21
Registration Number
NCT05997056
Locations
🇺🇸

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States

🇺🇸

Rocky Mountain Cancer Centers, Denver, Colorado, United States

🇺🇸

Texas Oncology, Dallas, Texas, United States

and more 1 locations

Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment

Phase 1
Recruiting
Conditions
Tumor, Solid
Tumor
Advanced Solid Tumor
Interventions
Drug: nab-sirolimus
First Posted Date
2022-12-22
Last Posted Date
2023-12-19
Lead Sponsor
Aadi Bioscience, Inc.
Target Recruit Count
28
Registration Number
NCT05661461
Locations
🇺🇸

South Texas Accelerated Research Therapeutics, LLC, San Antonio, Texas, United States

🇺🇸

START Mountain Region, West Valley City, Utah, United States

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

Phase 2
Active, not recruiting
Conditions
Neoplasms
TSC1
Malignant Solid Tumor
Malignant Solid Neoplasm
Cancer Metastatic
Solid Tumor
Malignant Neoplasm
Tumor
Tumor, Solid
Metastasis
Interventions
Drug: nab-sirolimus
First Posted Date
2021-11-02
Last Posted Date
2024-06-03
Lead Sponsor
Aadi Bioscience, Inc.
Target Recruit Count
120
Registration Number
NCT05103358
Locations
🇺🇸

Alabama Oncology, Birmingham, Alabama, United States

🇺🇸

Southern Cancer Center, Mobile, Alabama, United States

🇺🇸

Arizona Oncology Associates, Irving, Texas, United States

and more 116 locations

Expanded Access for ABI-009 in Patients With Advanced PEComa and Patients With a Malignancy With Relevant Genetic Mutations or mTOR Pathway Activation

Conditions
PEComa, Malignant
TSC1
TSC2
mTOR Pathway Abberation
First Posted Date
2019-01-25
Last Posted Date
2022-03-16
Lead Sponsor
Aadi Bioscience, Inc.
Registration Number
NCT03817515
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News

Nab-Sirolimus Demonstrates Promising Outcomes in Advanced PEComa Treatment

• Nab-sirolimus (Fyarro) has gained FDA approval for advanced malignant perivascular epithelioid cell tumors (PEComa), offering a new treatment option for this rare cancer. • The AMPECT trial demonstrated a 39% objective response rate, a median progression-free survival of 10.6 months, and an overall survival of 53.1 months with nab-sirolimus. • Unlike some therapies, nab-sirolimus does not require biomarker testing for treatment eligibility, expanding access for patients with PEComa. • The agent shows a favorable safety profile, with most adverse events being mild and manageable, leading to low discontinuation rates.

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