Description:
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.
Clinical Trials /
A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors
NCT02743637
Related Conditions:
- Malignant Solid Tumor
Recruiting Status:
Completed
Phase:
Phase 1
Trial Eligibility
Document
Title
- Brief Title: A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors
- 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 IDs
- ORG STUDY ID: SDX-0101
- NCT ID: NCT02743637
Conditions
- Advanced Malignancy
- Advanced Solid Tumors
- Neoplasm
- Metastasis
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| SDX-7320 | SDX-7320 |
Purpose
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).
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| SDX-7320 | Experimental | Increasing dose cohorts, until the maximum tolerated dose (MTD) is determined. |
|
Eligibility Criteria
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.
| Maximum Eligible Age: | 85 Years |
| Minimum Eligible Age: | 21 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of participants with adverse events as a measure of safety and tolerability of SDX-7320 to find the recommended Phase II dose |
| Time Frame: | Up to 30 days after last subject enrolled |
| Safety Issue: | |
| Description: |
Secondary Outcome Measures
| Measure: | Anti-tumor activity |
| Time Frame: | From the screening visit though the end of the last cycle on treatment, an expected average of 16 weeks |
| Safety Issue: | |
| Description: | RECIST v1.1 |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | SynDevRx, Inc. |
Trial Keywords
- Cancer
- Oncology
- Solid Tumors
- Phase 1
- SDX-7320
- SynDevRx
- MetAP2
- Breast
- Post menopausal
- Colorectal
- Pancreatic
- Ovarian
- Endometrial
- Esophageal
- Lung
- Renal
- Prostate
- Liver
Last Updated
January 27, 2020
