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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Aadi Bioscience, Inc.
Study ID
NCT05661461
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Tumor
  • Tumor, Solid

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nab-sirolimus — DRUG
    This is a phase 1, multi-center, open-label, dose-escalation study of nab-sirolimus in adult patients with locally advanced or metastatic solid tumors and moderate hepatic impairment or normal hepatic function.

Study Details

This is a phase 1, multi-center, open-label, dose-escalation study of nab-sirolimus in adult patients with locally advanced or metastatic solid tumors and moderate hepatic impairment or normal hepatic function.

Key Dates

Start date
Nov 23, 2022
Status verified
Nov 2025
Primary completion
Jun 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    nab-Sirolimus

Primary Outcome Measure

MTD for patients with moderate hepatic impairment [ Time Frame: Through Day 22 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
South Texas Accelerated Research Therapeutics, LLCSan AntonioTexas78229
Corina Zamora
[email protected]
Amita Patnaik, MD FRCP(C) (PRINCIPAL_INVESTIGATOR)
START Mountain RegionWest Valley CityUtah84119
Marianne Herndon
[email protected]
Justin Call, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Antonio, TX

By research site
South Texas Accelerated Research Therapeutics, LLC· San Antonio, TXSTART Mountain Region· West Valley City, UT

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