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

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.

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).

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.