Last updated on April 2019

A Study of RGX-202-01 With or Without FOLFIRI in Patients With Advanced Gastrointestinal Malignancies

Brief description of study

RGX-202-001 is a Phase 1, first-in-human, dose escalation and expansion study of RGX-202-01 as a single agent and in combination with FOLFIRI. RGX-202-01 is a small molecule inhibitor of the creatine transporter SLC6a8, a novel metabolic target that drives gastrointestinal cancer progression.

During the dose escalation stage, multiple doses of orally administered RGX-202-01 with or without FOLFIRI (single agent or combination therapy) will be evaluated in patients with advanced gastrointestinal tumors (i.e., locally advanced and unresectable, or metastatic) who have had PD on available standard systemic therapies or for which there are no standard systemic therapies of relevant clinical impact.

In the expansion stage of the study, additional patients with advanced gastrointestinal malignancies selected by expression of the creatine kinase B (CKB) biomarker, gastric/gastroesophageal cancer, or colorectal cancer (CRC) will be treated at the MTD (or maximum tested dose if no MTD is identified, or dose below the MTD if there is evidence suggesting a more favorable risk/benefit profile). This stage will provide further characterization of the safety, efficacy, PK, and pharmacodynamics of RGX-202-01 as a single agent (selected by expression of the CKB biomarker) and in combination with FOLFIRI (gastric/gastroesophageal cancer and CRC).

Clinical Study Identifier: NCT03597581

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City of Hope

Duarte, CA United States
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Cedars-Sinai Medical Center

Los Angeles, CA United States
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UCLA Department of Medicine

Santa Monica, CA United States
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Tennessee Oncology

Nashville, TN United States
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