SDX-0101: A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors

Sponsor

SynDevRx, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02743637

Collaborator

(none)

Enrollment

Locations

Arm

46.5

Actual Duration (Months)

10.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Malignancy Advanced Solid Tumors Neoplasm Metastasis	Drug: SDX-7320	Phase 1

Detailed 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).

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 1, 2016

Actual Primary Completion Date :

Dec 16, 2019

Actual Study Completion Date :

Dec 16, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Anti-tumor activity [From the screening visit though the end of the last cycle on treatment, an expected average of 16 weeks]
RECIST v1.1

Other Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HonorHealth Research Institute	Scottsdale	Arizona	United States	85258
2	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
3	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203