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

SynDevRx, Inc.32 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Malignancy Advanced Solid Tumors Neoplasm Metastasis

Interventions

SDX-7320DRUG

SDX-7320 is a synthetic copolymer-drug conjugate of a novel MetAP2 inhibitor.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Number of participants with adverse events as a measure of safety and tolerability of SDX-7320 to find the recommended Phase II dose

Time frame: Up to 30 days after last subject enrolled

Secondary Outcomes

Anti-tumor activity

RECIST v1.1

Time frame: From the screening visit though the end of the last cycle on treatment, an expected average of 16 weeks

Data from ClinicalTrials.gov

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