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

Advanced Solid Tumors Clinical Trial

— SDX-0101  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743637
• Other study ID #: SDX-0101
• Status: Completed
• Phase: Phase 1
• Start date: February 2016
• Est. completion date: December 16, 2019

Study information

• Verified date: January 2020
• Source: SynDevRx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Malignancy
• Advanced Solid Tumors
• Metastasis
• Neoplasm
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	HonorHealth Research Institute	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
SynDevRx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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

External Links

•   Sponsor Website