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mTOR Inhibitor

Experimental for Tumors

Phase 1

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 time 0 to 168 hours (auc 0-168)

Awards & highlights

Study Summary

This trial tests a drug to treat solid tumors in adults with normal or impaired liver function.

Who is the study for?

Adults with advanced or metastatic solid tumors and moderate liver issues (or normal liver function) can join this trial. They must be able to consent, have an ECOG score of 0-2, not be pregnant or breastfeeding, use effective birth control, and have recovered from previous treatments. People with severe lung problems, uncontrolled illnesses, recent heart attacks or infections requiring IV antibiotics cannot participate.Check my eligibility

What is being tested?

The study is testing different doses of nab-sirolimus to find a safe amount for patients with solid tumors who also have moderate liver impairment. It's an early-phase trial where everyone gets the drug; there are no comparison groups.See study design

What are the potential side effects?

Since nab-sirolimus is still being studied in early trials, specific side effects aren't fully known yet. However, it may cause similar side effects as other drugs in its class like mouth sores, rash, fatigue, diarrhea and blood sugar changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time 0 to 168 hours (auc 0-168)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time 0 to 168 hours (auc 0-168)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time 0 to 168 hours (auc 0-168) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MTD for patients with moderate hepatic impairment

Maximum concentration (Cmax)

Secondary outcome measures

Accumulation ratio based on AUC0-168

Accumulation ratio based on Cmax

Area under the serum concentration-time curve

+7 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%

Myelosuppression (Anemia)

27%

Weight decreased

25%

Decreased appetite

22%

Mucosal inflammation

18%

Hypokalemia

18%

Vomiting

18%

Lipase increased

18%

Dermatitis

17%

Dysgeusia

17%

Epistaxis

15%

Hyperglycemia

13%

Amylase increased

12%

Hypercholesterolemia

12%

Abdominal pain

10%

Headache

10%

Infection

10%

Hypophosphataemia

ALT

Anal inflammation

Dry mouth

AST

Proctalgia

Candida infection

Hypoalbuminaemia

Dehydration

Hypomagnesaemia

Nail disorder

Dry eye

Application site pain

Dry skin

Alopecia

Gastrooesophageal reflux disease

Oedema peripheral

Dizziness

Taste disorder

Proteinuria

Hypertension

Anorexia

Rectal perforation

Enterocolitis infectious

Pneumonia

Colitis

Stomatitis

100%

80%

60%

40%

20%

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: ExperimentalExperimental Treatment1 Intervention

nab-Sirolimus

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

nab-sirolimus

2018

Completed Phase 2

~130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Aadi Bioscience, Inc.Lead Sponsor

16 Previous Clinical Trials

513 Total Patients Enrolled

2 Trials studying Tumors

149 Patients Enrolled for Tumors

Media Library

nab-sirolimus (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05661461 — Phase 1

Tumors Research Study Groups: Experimental

Tumors Clinical Trial 2023: nab-sirolimus Highlights & Side Effects. Trial Name: NCT05661461 — Phase 1

nab-sirolimus (mTOR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05661461 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Experimental drug attained regulatory approval from the FDA?

"Preliminary evidence indicates that the experimental treatment is safe, so it was assigned a score of 1 on our scale. This rating reflects the limited data available to support both safety and efficacy at this Phase 1 trial stage."

Answered by AI

How many participants are engaging in this experiment?

"Indeed, the information hosted on clinicaltrials.gov verifies that this medical study is currently seeking participants. This trial was initially posted on November 23rd 2022 and has been updated as of December 14th 2022. The research team are looking for 28 patients from 2 distinct sites to join."

Answered by AI

Are there any opportunities to join this clinical trial at present?

"Affirmative. The clinicaltrials.gov website has evidence that this medical trial, first posted on November 23rd 2022, is still open for recruitment. 28 patients are expected to be enrolled from 2 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05661461.