Advanced Malignancy, Advanced Solid Tumors, Metastasis, Neoplasm
Conditions
Keywords
Cancer, Oncology, Solid Tumors, Phase 1, SDX-7320, SynDevRx, MetAP2, Breast, Post menopausal, Colorectal, Pancreatic, Ovarian, Endometrial, Esophageal, Lung, Renal, Prostate, Liver
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.
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).
Interventions
DRUGSDX-7320
SDX-7320 is a synthetic copolymer-drug conjugate of a novel MetAP2 inhibitor.
Sponsors
SynDevRx, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed