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mTOR Inhibitor

Nab-Sirolimus + Letrozole for Endometrial Cancer

Phase 2
Recruiting
Research Sponsored by Aadi Bioscience, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a combination of drugs to treat advanced or recurring endometrial cancer.

Who is the study for?
This trial is for adults with advanced or recurrent endometrioid endometrial cancer that can't be removed by surgery. Participants must have measurable cancer, acceptable organ function, and no severe infections or heart disease. They should not be pregnant, agree to use contraception, and cannot have certain other cancers or HIV/AIDS complications.
What is being tested?
The study tests nab-Sirolimus combined with Letrozole in patients with a specific type of uterine cancer. It's an open-label Phase 2 trial where everyone gets the same treatment to see how effective it is at controlling the disease.
What are the potential side effects?
Potential side effects may include reactions related to immune suppression due to mTOR inhibition (like increased risk of infection), metabolic changes such as altered cholesterol and triglyceride levels, and possible interactions with other medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate (ORR)
Secondary study objectives
Disease Control Rate (DCR): CR or PR
Duration of response (DOR)
Incidence and severity
+3 more

Side effects data

From 2022 Phase 1 & 2 trial • 60 Patients • NCT03439462
67%
Mucositis
58%
Fatigue
43%
Rash
38%
Diarrhea
37%
Myelosuppression (Thrombocytopenia)
35%
Nausea
30%
Myelossupression (Neutropenia)
28%
Hypertriglyceridemia
27%
Weight decreased
27%
Myelosuppression (Anemia)
25%
Decreased appetite
22%
Mucosal inflammation
18%
Lipase increased
18%
Dermatitis
18%
Hypokalemia
18%
Vomiting
17%
Epistaxis
17%
Dysgeusia
15%
Hyperglycemia
13%
Amylase increased
12%
Abdominal pain
12%
Hypercholesterolemia
10%
Headache
10%
Infection
10%
Hypophosphataemia
8%
ALT
8%
Dry mouth
8%
Anal inflammation
8%
AST
7%
Candida infection
7%
Hypoalbuminaemia
7%
Proctalgia
7%
Dehydration
5%
Nail disorder
5%
Dizziness
5%
Application site pain
5%
Proteinuria
5%
Alopecia
5%
Anorexia
5%
Gastrooesophageal reflux disease
5%
Oedema peripheral
5%
Dry eye
5%
Hypertension
5%
Hypomagnesaemia
5%
Dry skin
5%
Taste disorder
2%
Pneumonia
2%
Colitis
2%
Enterocolitis infectious
2%
Rectal perforation
2%
Stomatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Total
Cohort 1: Nab-Sirolimus 30 mg/m2 qw3/4
Cohort 2 Nab-Sirolimus 20 mg/m2 qw3/4
Cohort 3: Nab-Sirolimus 20 mg/m2 qw2/4

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Endometrioid Endometrial CancerExperimental Treatment1 Intervention
Patients with advanced or recurrent endometrioid endometrial carcinoma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nab-sirolimus
2017
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Aadi Bioscience, Inc.Lead Sponsor
17 Previous Clinical Trials
549 Total Patients Enrolled
Willis Navarro, MDStudy DirectorAadi Bioscience
8 Previous Clinical Trials
132 Total Patients Enrolled

Media Library

nab-Sirolimus (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05997017 — Phase 2
Cancer Research Study Groups: Endometrioid Endometrial Cancer
Cancer Clinical Trial 2023: nab-Sirolimus Highlights & Side Effects. Trial Name: NCT05997017 — Phase 2
nab-Sirolimus (mTOR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05997017 — Phase 2
~4 spots leftby Mar 2025
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