Nab-Sirolimus

Phase 2Small molecule

Nab-Sirolimus is one of 143 small molecule programs targeting Locally Advanced or Metastatic Solid Tumors. It is currently in Phase 2.

Indications

Total Trials

Active Trials

142

Competitors

Pipeline

Status by Indication[3][1]

Indication

Locally Advanced or Metastatic Solid TumorsRecruiting

Malignant Solid TumorsActive, not recruiting

LeiomyosarcomaRecruiting

Epithelioid HemangioendotheliomaRecruiting

Ovarian CancerRecruiting

Endometrial CancerRecruiting

Locally Advanced or Metastatic Solid TumorsPhase 1

Recruiting

Malignant Solid TumorsPhase 2

Active, not recruiting

LeiomyosarcomaPhase 1

Recruiting

Epithelioid HemangioendotheliomaPhase 2

Recruiting

Ovarian CancerPhase 2

Recruiting

Endometrial CancerPhase 2

Recruiting

Competition

Competitive Landscape

232 competitors in Ovarian Cancer

#DrugCompanyPhaseTrials

Gemzar

Johnson & Johnson

Phase 3

33 2

Keytruda

Merck & Co.

Phase 3

28 3

Hycamtin

MMeitheal

Phase 3

26 4

Cytoxan

BBaxter Healthcare Corporation

Phase 3

24 5

Femara

Novartis

Phase 3

8 6

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

23 7

Rubraca

Bristol-Myers Squibb

Phase 3

6 8

Trodelvy

Gilead

Phase 3

4 9

Neulasta

Amgen

Phase 3

2 10

Taxotere

AAvyxa

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Endometrial Cancer

NCT05997017

Q3 2029

Phase 2Recruiting

Epithelioid Hemangioendothelioma

NCT07104331

Phase 2Recruiting

Ovarian Cancer

NCT06494150

Q1 2031

Phase 1Recruiting

Leiomyosarcoma

NCT06308419

Clinical

Trials by Indication[1]

Locally Advanced or Metastatic Solid Tumors1 trial

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

Recruiting·AAadi Bioscience, Inc.·Phase 1·NCT05661461·28 enrolled

Leiomyosarcoma1 trial

A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06308419·18 enrolled

Pulmonary Arterial Hypertension1 trial

Phase 1/1b Study With Nab-sirolimus for Patients With Severe Pulmonary Arterial Hypertension

Completed·AAadi Bioscience, Inc.·Phase 1·NCT02587325·15 enrolled

Endometrial Cancer1 trial

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

Recruiting·AAadi Bioscience, Inc.·Phase 2·NCT05997017·29 enrolled

Malignant Solid Tumors1 trial

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

Active, not recruiting·AAadi Bioscience, Inc.·Phase 2·NCT05103358·120 enrolled

7 more indications

Glioblastoma1 trial

Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma

Completed·AAadi Bioscience, Inc.·Phase 2·NCT03463265·62 enrolled

Epithelioid Hemangioendothelioma1 trial

SARC046: A Phase II Trial of Nab-Sirolimus in Patients With Progressing or Symptomatic Epithelioid Hemangioendothelioma

Recruiting·SSarcoma Alliance for Research through Collaboration·Phase 2·NCT07104331·41 enrolled

Ovarian Cancer1 trial

Nab-Sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer (NARETO)

Recruiting·UUniversity of Oklahoma·Phase 2·NCT06494150·37 enrolled

PEComa1 trial

A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa

Completed·AAadi Bioscience, Inc.·Phase 2·NCT02494570·34 enrolled

Metastatic Colorectal Cancer1 trial

Nab-Sirolimus in Combination With FOLFOX & BEV as 1st Line Therapy in Patients With Advanced or Metastatic Colorectal Cancer

Completed·AAadi Bioscience, Inc.·Phase 1/2·NCT03439462·60 enrolled

Non-Small Cell Lung Cancer1 trial

Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation (KRYSTAL -19)

Terminated·MMirati Therapeutics Inc.·Phase 1·NCT05840510·6 enrolled

Neuroendocrine Tumors1 trial

A Phase 2 Multi-center, Open-label, Single Arm Study 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

Completed·AAadi Bioscience, Inc.·Phase 2·NCT05997056·12 enrolled

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Nab-Sirolimus. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nab-Sirolimus compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nab-Sirolimus. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Mirati Therapeutics Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: MMirati Therapeutics Inc.

Nab-Sirolimus

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2029

Q1 2031

Trials by Indication[1]

Locally Advanced or Metastatic Solid Tumors1 trial

Leiomyosarcoma1 trial

Pulmonary Arterial Hypertension1 trial

Endometrial Cancer1 trial

Malignant Solid Tumors1 trial

Glioblastoma1 trial

Epithelioid Hemangioendothelioma1 trial

Ovarian Cancer1 trial

PEComa1 trial

Metastatic Colorectal Cancer1 trial

Non-Small Cell Lung Cancer1 trial

Neuroendocrine Tumors1 trial

References

Drug Info

Quick Facts

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