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

• Status: Completed
• Trial end date: 2019-12-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SynDevRx, Inc.

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.