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NCT Number: NCT02743637

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.

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Key information

Conditions

Advanced Malignancy Advanced Solid Tumors Metastasis Neoplasm Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

HonorHealth Research Institute, Scottsdale, Arizona, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SDX-7320

Drug

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

Primary outcomes

  1. 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

  1. Anti-tumor activity

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

    RECIST v1.1

Other outcomes

  1. Peak plasma concentration (Cmax) of active moiety SDX7539

    Time frame: Cycle 1, 3, and 6 Day 1: predose, 3, 6, 24, 48, 96 hours; Cycle 2, 4, and 5: predose

  2. Area under the plasma concentration curve from zero to infinity AUC (0-inf) active moiety SDX7539

    Time frame: Cycle 1, 3, and 6 Day 1: predose, 3, 6, 24, 48, 96 hours; Cycle 2, 4, and 5: predose

Sponsors and collaborators

Lead sponsor

SynDevRx, Inc.

Industry

Registry information

Official study title

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

Acronym: SDX-0101

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2016
Registry last updated
Jan 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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