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This is the first study to test Sym021 in humans. The primary purpose of this study is to see if Sym021 is safe and tolerable for patients with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available.
This study will evaluate the preliminary safety, tolerability, and dose-limiting toxicities (DLTs) of Sym021, an anti-programmed cell death protein 1 (PD-1) monoclonal antibody (mAb) . The goal is to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of sequential escalating doses of Sym021 when administered once every 2 weeks (Q2W) by 30-minute intravenous (IV) infusion to patient cohorts with locally advanced/unresectable or metastatic solid tumor malignancies or lymphomas that are refractory to available therapy or for which no standard therapy is available. If an MTD is not identified, a maximum administered dose (MAD) will be determined.
Sym021 will be given to patients in escalating dose cohorts; each patient will be given one fixed dose level. There will be a minimum of 3 patients per dose cohort, assuming approximately 3 dose cohorts to be evaluated to establish the MTD and/or RP2D dose. Any cohort will be expanded to 6 patients in the event of a Cycle 1 DLT in any of the initial 3 patients. A minimum of 6 patients are to be treated at the MTD and/or RP2D dose; expansion of this cohort (or any other) up to 12 patients may be considered to further evaluate tolerability.
In addition, there is potential for entry of additional patients for the following reasons:
- To ensure sufficient evaluable patients by adding an additional patient to a cohort (e.g. increase a 3-patient cohort to 4 patients, or a 6-patient cohort to 7 patients).
- To expand a lower dose cohort(s) if an initially identified MTD and/or RP2D is subsequently determined not to be tolerated either with single or repeated cycles of therapy.
- To add and evaluate a previously unexamined intermediate dose level(s) to further characterize safety and tolerability, if indicated.
South Texas Accelerated Research Therapeutics (START) Midwest
Not yet recruiting
Published on BioPortfolio: 2017-10-22T20:10:13-0400
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