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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SDX-7320 | Experimental | Increasing dose cohorts, until the maximum tolerated dose (MTD) is determined. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SDX-7320 | Drug | SDX-7320 is a synthetic copolymer-drug conjugate of a novel MetAP2 inhibitor. |
|
| 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 |
| 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 |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neal Salomon, MD | SynDevRx, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| Cedars Sinai Medical Center |
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| Label | URL |
|---|---|
| Sponsor Website | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Los Angeles |
| California |
| 90048 |
| United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |