Clinical Trials /

Phase 1 Study of SQ3370 in Patients With Advanced Solid Tumors

NCT04106492

Description:

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SQ3370 in patients with cancer (solid tumors).

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase 1 Study of SQ3370 in Patients With Advanced Solid Tumors
  • Official Title: A Multicenter Phase 1, Open-Label Study of SQ3370 in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: SQ3370-001
  • NCT ID: NCT04106492

Conditions

  • Cancer

Interventions

DrugSynonymsArms
SQ3370SQ3370

Purpose

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of SQ3370 in patients with cancer (solid tumors).

Trial Arms

NameTypeDescriptionInterventions
SQ3370Experimental
  • SQ3370

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of an advanced local or metastatic solid tumor

          -  Adequate hematologic, hepatic, renal, and coagulation function

        Exclusion Criteria:

          -  Prior exposure to 225 mg/m2 of Dox HCl or DOXIL / CAELYX ® or 450 mg/m2 of epirubicin
             HCl.

          -  CHF, severe myocardial insufficiency, or cardiac arrhythmia

          -  Any of the following within 28 days prior to Cycle 1 Day 1:

          -  Major surgery, as defined by the Investigator

          -  Radiotherapy

          -  Chemotherapy

          -  Currently enrolled in or discontinued from a clinical study involving an
             investigational agent or non-approved use of a drug or device, or concurrently
             enrolled in any other type of medical research judged not to be scientifically or
             medically compatible with this study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability of SQ3370, including determination of the maximum tolerated dose and the recommended Phase 2 dose.
Time Frame:35 Days
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Shasqi, Inc.

Trial Keywords

  • Sarcoma
  • Cancer
  • Tumor
  • Soft Tissue Sarcoma
  • Solid Tumor
  • Doxorubicin
  • Intratumoral
  • Anthracycline
  • Phase 1

Last Updated

June 2, 2020