A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors (SDX-0101)

January 22, 2020 updated by: SynDevRx, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SDX-7320
Increasing dose cohorts, until the maximum tolerated dose (MTD) is determined.
Drug: SDX-7320
SDX-7320 is a synthetic copolymer-drug conjugate of a novel MetAP2 inhibitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 30 days after last subject enrolled

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Peak plasma concentration (Cmax) of active moiety SDX7539
Time Frame: Cycle 1, 3, and 6 Day 1: predose, 3, 6, 24, 48, 96 hours; Cycle 2, 4, and 5: predose
Cycle 1, 3, and 6 Day 1: predose, 3, 6, 24, 48, 96 hours; Cycle 2, 4, and 5: predose
Area under the plasma concentration curve from zero to infinity AUC (0-inf) active moiety SDX7539
Time Frame: Cycle 1, 3, and 6 Day 1: predose, 3, 6, 24, 48, 96 hours; Cycle 2, 4, and 5: predose
Cycle 1, 3, and 6 Day 1: predose, 3, 6, 24, 48, 96 hours; Cycle 2, 4, and 5: predose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SynDevRx, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

December 16, 2019

Study Completion (Actual)

December 16, 2019

Study Registration Dates

First Submitted

April 7, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDX-0101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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