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

NCT02743637 | Completed Phase 1

• 1 other identifier: SDX-0101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Malignancy; Advanced Solid Tumors; Neoplasm; Metastasis

Keywords

Cancer; Oncology; Solid Tumors; Phase 1; SDX-7320; SynDevRx; MetAP2; Breast; Post menopausal; Colorectal; Pancreatic; Ovarian; Endometrial; Esophageal; Lung; Renal; Prostate; Liver

Outcome Measures

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

  Up to 30 days after last subject enrolled

Secondary Outcomes (1)

• Anti-tumor activity

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

Other Outcomes (2)

• Peak plasma concentration (Cmax) of active moiety SDX7539

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

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

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

Study Arms (1)

SDX-7320

EXPERIMENTAL

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

Drug: SDX-7320

Interventions

SDX-7320 DRUG

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

SDX-7320

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SynDevRx, Inc.: lead

Study Sites (3)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Related Links

• Sponsor Website

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Neal Salomon, MD

  SynDevRx, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 19, 2016
• Study Start: February 1, 2016
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

US (3)