A Dose Escalation Study Of SDX-7320 In Patients With Advanced Refractory Or Late-Stage Solid Tumors

Study Overview

A Dose Escalation Study of SDX-7320 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).

Advanced Malignancy
Advanced Solid Tumors
Neoplasm
Metastasis

DRUG: SDX-7320

SDX-0101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-04-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-01-22
First Submitted that Met QC Criteria 2016-04-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-01-27
First Posted (ACTUAL) 2016-04-19	Results First Posted N/A	Last Verified 2020-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: SDX-7320 Increasing dose cohorts, until the maximum tolerated dose (MTD) is determined.	DRUG: SDX-7320 SDX-7320 is a synthetic copolymer-drug conjugate of a novel MetAP2 inhibitor.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: SDX-7320

Increasing dose cohorts, until the maximum tolerated dose (MTD) is determined.

DRUG: SDX-7320

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

Primary Outcome Measures	Measure Description	Time Frame
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	Measure Description	Time Frame
Anti-tumor activity	RECIST v1.1	From the screening visit though the end of the last cycle on treatment, an expected average of 16 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
21 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Neal Salomon, MD, SynDevRx, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record