CompletedPhase 1NCT02743637
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSDX-7320

The study team can explain what participation involves.

Who it may be forResistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 27, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?SynDevRx, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
SynDevRx, Inc.
Interventions being studied
Drug: SDX-7320
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • HonorHealth Research InstituteScottsdale, Arizona
  • Cedars Sinai Medical CenterLos Angeles, California
  • Sarah Cannon Research InstituteNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 27, 2020. Always confirm current availability with the study team.

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