Pipeline

PopulationsPhase 1 Phase 2ApprovedCurrent Status
precision-logoAdvanced Malignant PEComa
AMPECT Clinical Trial

Single Agent

 
First FDA approved therapy for advanced malignant PEComa
precision-logoPan-Tumor TSC1/TSC2 Inactivating Alterations

TSC1 Arm, Single Agent

 
Registration directed tumor-agnostic pivotal study in nab-sirolimus with arms for TSC1 and TSC2 inactivating alterations; open for enrollment
precision-logoPan-Tumor TSC1/TSC2 Inactivating Alterations

TSC2 Arm, Single Agent

 
Registration directed tumor-agnostic pivotal study in nab-sirolimus with arms for TSC1 and TSC2 inactivating alterations; open for enrollment
Advanced or recurrent endometrial cancer

nab-sirolimus + letrozole

 
Trial combining nab-sirolimus with letrozole for patients with endometrioid-type endometrial carcinoma; trial initiation in 4Q 2023
Neuroendocrine tumors (NETs)

Single Agent

 
Utilizing nab-sirolimus as a monotherapy in neuroendocrine tumors; trial initiation in 4Q 2023
Advanced solid tumors or NSCLC with KRASG12C mutation

nab-sirolimus
+ adagrasib

 
Ongoing collaboration with
mirati-logo Currently open for enrollment
DrugStageCurrent Status
precision-logoAdvanced Malignant PEComa
AMPECT Clinical Trial Single Agent
Approved
First FDA approved therapy for advanced malignant PEComa
precision-logoPan-Tumor TSC1/TSC2 Inactivating Alterations TSC1 Arm, Single Agent Phase 2
Registration directed tumor-agnostic pivotal study in nab-sirolimus with arms for TSC1 and TSC2 inactivating alterations; open for enrollment
precision-logoPan-Tumor TSC1/TSC2 Inactivating Alterations TSC2 Arm, Single Agent Phase 2
Registration directed tumor-agnostic pivotal study in nab-sirolimus with arms for TSC1 and TSC2 inactivating alterations; open for enrollment
Advanced or recurrent endometrial cancer nab-sirolimus + letrozole Phase 2
Trial combining nab-sirolimus with letrozole for patients with endometrioid-type endometrial carcinoma; trial initiation in 4Q 2023
Neuroendocrine tumors (NETs) Single Agent Phase 2
Utilizing nab-sirolimus as a monotherapy in neuroendocrine tumors; trial initiation in 4Q 2023
Advanced solid tumors or NSCLC with KRASG12C mutation nab-sirolimus
+ adagrasib
Phase 1
Ongoing collaboration with
mirati-logo Currently open for enrollment

Evaluation of additional new nab-sirolimus and combination trials ongoing.