Trial | NCT02743637  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sdx-7320 ...

  • Study Participants

    32
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 Started
Feb 29
2016
Primary Completion
Dec 16
2019
Study Completion
Dec 16
2019
Last Update
Jan 27
2020

Drug SDX-7320

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

SDX-7320 Experimental

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

Criteria 

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.
No Results Posted