Advanced Malignant Solid Neoplasm Clinical Trial
Official title:
Phase I Study of GSK525762C and Entinostat in Advanced and Refractory Solid Tumors and Lymphomas
This phase I trial studies the side effects and best dose of GSK525762C (molibresib besylate) and entinostat in treating patients with solid tumors or lymphomas that have spread to other parts of the body (advanced) or are not responding to treatment (refractory). GSK525762C and entinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This study may help doctors find out if giving the combination of GSK525762C and entinostat is better or worse than the usual approach for treating solid tumors or lymphomas.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of GSK525762C and entinostat in combination
in patients with advanced and refractory solid tumors and lymphomas based on dose limiting
toxicities (DLTs) of the combination of GSK525762C and entinostat.
SECONDARY OBJECTIVES:
I. To describe the safety profile of GSK525762C and entinostat in advanced and refractory
solid tumors and lymphomas.
II. To determine the overall response rate (ORR) of GSK525762C and entinostat in advanced and
refractory solid tumors and lymphomas.
III. To determine the progression-free survival (PFS), duration of response (DOR), and
overall survival (OS) of GSK525762C and entinostat in this patient population.
EXPLORATORY OBJECTIVES:
I. To assess the effect of GSK525762C and entinostat therapy on apoptosis, as measured by an
apoptosis multiplex immunoassay.
II. To assess the effect of GSK525762C and entinostat therapy on c-MYC and YAP1 as measured
by ribonucleic acid (RNA) and protein expression.
III. To assess the effect of GSK525762C and entinostat therapy on tumor burden and gene
expression patterns as measured by whole exome sequencing (WES) and RNA sequencing (RNASeq)
on circulating tumor deoxyribonucleic acid (DNA) (ctDNA) specimens.
OUTLINE: This is a dose-escalation study.
Patients receive entinostat orally (PO) on days 1, 8, 15, and 22, and molibresib PO once
daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
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