Clinical Trials /

A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors

NCT02743637

Description:

This is a Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated dose of subcutaneous administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors
  • Official Title: A Phase 1 Dose Escalation Study of SDX-7320 to Assess the Safety and Tolerability in Patients With Advanced Refractory or Late-Stage Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: SDX-0101
  • NCT ID: NCT02743637

Conditions

  • Advanced Malignancy
  • Advanced Solid Tumors
  • Neoplasm
  • Metastasis

Interventions

DrugSynonymsArms
SDX-7320SDX-7320

Purpose

This is a Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated dose of subcutaneous administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.

Detailed Description

      This is a Phase 1 dose escalation study to assess the safety and tolerability of
      subcutaneously administered SDX-7320 in patients with advanced refractory or late-stage
      solid tumors.

      Once the MTD has been determined up to 12 patients will be treated at this dose level, to
      further characterize treatment emergent adverse events (TEAEs).
    

Trial Arms

NameTypeDescriptionInterventions
SDX-7320ExperimentalIncreasing dose cohorts, until the maximum tolerated dose (MTD) is determined.
  • SDX-7320

Eligibility Criteria

        Inclusion Criteria:

          -  Patients have at least one site of radiographically measurable disease.

          -  Eastern Cooperative Oncology Group (ECOG) status ≤1.

          -  Adequate renal and liver functions.

          -  Life expectancy ≥3 months.

        Exclusion Criteria:

          -  Patients that have undergone organ transplant surgery.

          -  The patient has a known history of Hepatitis A, B, or C and is on active anti-viral
             therapy.

          -  History of gastric bypass surgery or banding procedure.

          -  Uncontrolled or refractory hypertension: systolic >180 or diastolic >110, or
             hypotension: systolic <90 or diastolic <50 despite medical treatment.

          -  Participation in any other trial of an investigational agent within 30 days prior to
             first dose of study drug.

          -  The resting 12-lead electrocardiogram obtained during screening shows QTc (Fridericia
             correction) ≥470 ms or has a congenital prolonged QT syndrome.
      
Maximum Eligible Age:85 Years
Minimum Eligible Age:21 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with adverse events as a measure of safety and tolerability of SDX-7320 to find the recommended Phase II dose
Time Frame:Up to 30 days after last subject enrolled
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Anti-tumor activity
Time Frame:From the screening visit though the end of the last cycle on treatment, an expected average of 16 weeks
Safety Issue:
Description:RECIST v1.1

Details

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

Trial Keywords

  • Cancer
  • Oncology
  • Solid Tumors
  • Phase 1
  • SDX-7320
  • SynDevRx
  • MetAP2
  • Breast
  • Post menopausal
  • Colorectal
  • Pancreatic
  • Ovarian
  • Endometrial
  • Esophageal
  • Lung
  • Renal
  • Prostate
  • Liver

Last Updated

April 12, 2017