A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors (SDX-0101)
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|ClinicalTrials.gov Identifier: NCT02743637|
Recruitment Status : Completed
First Posted : April 19, 2016
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignancy Advanced Solid Tumors Neoplasm Metastasis||Drug: SDX-7320||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||February 2016|
|Actual Primary Completion Date :||December 16, 2019|
|Actual Study Completion Date :||December 16, 2019|
Increasing dose cohorts, until the maximum tolerated dose (MTD) is determined.
SDX-7320 is a synthetic copolymer-drug conjugate of a novel MetAP2 inhibitor.
- 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 ]
- Anti-tumor activity [ Time Frame: From the screening visit though the end of the last cycle on treatment, an expected average of 16 weeks ]RECIST v1.1
- Peak plasma concentration (Cmax) of active moiety SDX7539 [ Time Frame: 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 [ Time Frame: Cycle 1, 3, and 6 Day 1: predose, 3, 6, 24, 48, 96 hours; Cycle 2, 4, and 5: predose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743637
|United States, Arizona|
|HonorHealth Research Institute|
|Scottsdale, Arizona, United States, 85258|
|United States, California|
|Cedars Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|Study Director:||Neal Salomon, MD||SynDevRx, Inc.|