A Study of RGX-104 in Patients With Advanced Lung & Endometrial Cancer

Active:	Yes
Cancer Type:	Lung Cancer Lymphoma Neuroendocrine Tumor Ovarian Cancer	NCT ID:	NCT02922764
Trial Phases:	Phase I	Protocol IDs:	RGX-104-001 (primary) NCI-2017-00226
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Inspirna, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT02922764

Summary

Study RGX-104-001 is a Phase 1, first-in-human, dose escalation and expansion study of
RGX-104, an oral small molecule targeting the liver X receptor (LXR), as a single agent
and in combination with nivolumab, ipilimumab, docetaxel, or pembrolizumab plus
carboplatin/pemetrexed.

Objectives

RGX-104 activates LXR, resulting in depletion of both myeloid-derived suppressor cells
(MDSCs) as well as tumor blood vessels. MDSCs block the ability of T-cells and other
cells of the immune system from attacking tumors.

During the dose escalation stage, multiple doses and schedules of orally administered
RGX-104 with or without nivolumab, ipilimumab, docetaxel, or pembrolizumab plus
carboplatin/pemetrexed (single agent or combination therapy) will be evaluated in
patients with advanced solid tumors and lymphoma (i.e., locally advanced and
unresectable, or metastatic) who have had progressive disease (PD) on available standard
systemic therapies or for which there are no standard systemic therapies of relevant
impact. Dose escalation in combination with pembrolizumab plus carboplatin/pemetrexed
will be restricted to patients with non-small cell lung cancer (NSCLC).

In the expansion stage of the study, additional patients with endometrial cancer,
epithelial ovarian carcinoma (EOC), NSCLC, or small cell lung cancer (SCLC)/high-grade
neuroendocrine tumors (HG-NET) 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, including biomarkers of immunologic activity and LXR
target activation, of RGX-104 as a single agent (EOC), in combination with docetaxel
(SCLC/HG-NET), and and in combination with pembrolizumab plus carboplatin/pemetrexed
(NSCLC).

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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