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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Advanced Malignancy, Advanced Solid Tumors, Neoplasm, Metastasis

Intervention / Treatment
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* Drug: SDX-7320


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SDX-7320<br>Increasing dose cohorts, until the maximum tolerated dose (MTD) is determined. | Drug: SDX-7320<br>* SDX-7320 is a synthetic copolymer-drug conjugate of a novel MetAP2 inhibitor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Oncology, Solid Tumors, Phase 1, SDX-7320, SynDevRx, MetAP2, Breast, Post menopausal, Colorectal, Pancreatic, Ovarian, Endometrial, Esophageal, Lung, Renal, Prostate, Liver