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

Phase 1

Completed

• Conditions: Advanced Solid Tumors; Neoplasm; Advanced Malignancy; Metastasis
• Interventions: Drug: SDX-7320

• Registration Number: NCT02743637
• Lead Sponsor: SynDevRx, Inc.

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-04-07
• Study First Submitted QC: 2016-04-14
• Study First Posted: 2016-04-19
• Primary Completion: 2019-12-16
• Study Completion: 2019-12-16
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SDX-7320	SDX-7320	Increasing dose cohorts, until the maximum tolerated dose (MTD) is determined.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability of SDX-7320 to find the recommended Phase II dose	Up to 30 days after last subject enrolled

Secondary Outcome Measures

Name	Time	Method
Anti-tumor activity	From the screening visit though the end of the last cycle on treatment, an expected average of 16 weeks	RECIST v1.1

Trial Locations

Locations (3)

HonorHealth Research Institute; 🇺🇸 Scottsdale, Arizona, United States

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States