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Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)

NCT05103358 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-06-03

No results posted yet for this study

Summary

A Phase 2 multi-center open-label basket trial of nab-sirolimus for adult and adolescent patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes

Conditions

  • Tumor
  • Tumor, Solid
  • Metastasis
  • Metastatic Cancer
  • Cancer
  • Cancer Metastatic
  • Tumors
  • Neoplasms
  • Neoplasm Metastasis
  • Solid Tumor
  • Advanced Solid Tumor
  • Advanced Cancer
  • Malignant Solid Tumor
  • Malignant Solid Neoplasm
  • Malignant Neoplasm
  • Malignant Tumor
  • TSC
  • TSC1
  • TSC2
  • Metastatic Solid Tumor
  • Metastatic Neoplasm

Interventions

DRUG

nab-sirolimus

Prospective phase 2, open-label, multi-institutional basket trial to determine the efficacy and safety of nab-sirolimus administered by IV infusion to patients

Sponsors & Collaborators

  • Aadi Bioscience, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2024-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05103358 on ClinicalTrials.gov