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

SynDevRx

Status and phase

Completed

Phase 1

Conditions

Neoplasm

Advanced Malignancy

Metastasis

Advanced Solid Tumors

Treatments

Drug: SDX-7320

Study type

Interventional

Funder types

Industry

Identifiers

NCT02743637

SDX-0101

Details and patient eligibility

About

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.

Full 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).

Enrollment

32 patients

Sex

All

Ages

21 to 85 years old

Volunteers

No Healthy Volunteers

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.