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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

ConditionsNeuroendocrine TumorsNETPancreatic Neuroendocrine TumorGastrointestinal Neuroendocrine TumorPulmonary Neuroendocrine Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAadi Bioscience, Inc.

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with functional or non-functional, well-differentiated, locally advanced unresectable or metastatic NETs of the GI tract, lung, or pancreas who have received 2 or less prior lines of therapy excluding somatostatin analogs

the patient has been on a stable dose of an somatostatin analogs for ≥12 weeks and

the patient has experienced disease progression while on stable somatostatin analogs dose

Patients must have 1 or more measurable target lesions by RECIST v1.1

Disqualifiers

Prior treatment with mTOR inhibitors including nab-sirolimus

Patients with functional NETs who are experiencing uncontrolled symptoms attributed to hormones and other vasoactive substances secreted by the tumor

Patients with inactivating TSC1 or TSC2 alterations (based on tissue or liquid NGS)

Severe (Grade ≥3) ongoing infection requiring parenteral or oral anti-infective treatment, either ongoing or completed ≤7 days prior to enrollment

Trial design

Design model

Single group

Treatments tested in this trial

  • nab-sirolimus

    Drug

    Prospective phase 2 single arm, open-label, multi-institutional study to determine the efficacy and safety prospective of nab-sirolimus administered by IV infusion

Treatment groups

21 Participants
are divided into 1 treatment group
Group A: neuroendocrine tumorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy of nab-sirolimus

Objective Response Rate (ORR), defined as the proportion of patients with best overall response (BOR) of confirmed partial response (PR) or complete response (CR) from the time of study treatment initiation until progression of disease (PD) as determined by the Investigator using RECIST v1.1

Time frame
12 Months

Secondary outcomes

1

Incidence and severity of treatment

Incidence and severity of treatment-emergent and treatment-related adverse events (AEs) as assessed by NCI CTCAE v5.0

Time frame
12 Months
2

Duration of response

Determined for patients with BOR of confirmed CR or PR defined as time from scan first showing response by RECIST v1.1 to PD or death

Time frame
12 Months
3

Disease control rate

BOR of confirmed CR or PR (either of any duration) or stable disease (SD) ≥12 weeks by RECISTv1.1 following study treatment initiation

Time frame
12 Months
4

Time to response

Time from first dose of study medication to initial measurement of CR or PR, where CR or PR is subsequently confirmed by RECIST v1.1

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aadi Bioscience, Inc.

Lead sponsor

Source ClinicalTrials.gov
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