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

Completed · Phase 1

Conditions studied: Advanced Malignancy, Advanced Solid Tumors, Neoplasm, Metastasis

In brief

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.

Key facts

Study ID

NCT02743637

Run by

SynDevRx, Inc.

People needed

32

Starts

2016-02-01

Expected to finish

2019-12-16

Last updated by the study team

2020-01-27

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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