Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Small Cell Lung Carcinoma

Recurrence

Endometrial Neoplasms

Disease Attributes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Carboplatin

Pemetrexed

Pembrolizumab

Docetaxel

Ipilimumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

RGX-104 in combination docetaxel

RGX104 120 mg BID (5day on/2days off)

RGX104 + pembrolizumab + carboplatin/pemetrexed

RGX104 120 mg BID (5day on/2days off)

RGX-104 + docetaxel

RGX104 120 mg BID (5day on/2days off)

RGX-104 combined with ipilimumab

RGX104 120 mg BID (5day on/2days off)

RGX-104

Steve Kaesshaefer

Stacey Kimbell

Sudhir Manda, MD

Monica Mita, MD

Cole Sprague

Erin Schenk, MD

Annie Carpenter

Allen Cohn, MD

Joshua Gordon, MD

Gerald Falchook, MD

Tanya Holoman

Alexander Philipovskiy, MD

Shikila Calder

Pratibha Desai, MD

Christa Baxter

Rebecca Redman, MD

Amanda Woolery

Nicole Perry

Daniel Johnson, MD

Ana Quinones

John Wallmark, MD

Shannon McGinty

Kurt Demel, MD

Ashley Burns

Sean Hobson, MD

Paulina Holly

Demmie Aguilar

Eugenia Girda, MD

Reena Vattakalam

June Hou, MD

Study Coordinator

Adbul Naqash, MD

Tracey Newhall

Rita Axelrod, MD

Anna Lesnik

Angela Jain, MD

Lilliana Payne

Alexander Spira, MD

Robert Wasserman, MD

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.

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).

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

A Phase 1 Study of RGX-104, a Small Molecule LXR Agonist, as a Single Agent and as Combination Therapy in Patients With Advanced Solid Malignancies and Expansion in Select Malignancies

Inspirna, Inc.

Spots Global Cancer Trial Database for lxr

Every month we try and update this database with for lxr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lxr

Every month we try and update this database with for lxr cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lxr cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.