Pilot trial of CRLX101 in patients with advanced, chemotherapy-refractory gastroesophageal cancer

Journal of Gastrointestinal Oncology
Joseph ChaoYun Yen

Abstract

CRLX101 is an investigational nanoparticle-drug conjugate with a camptothecin payload. Preclinical evidence indicated preferential uptake in tumors, and tumor xenograft models demonstrate superiority of CRLX101 over irinotecan. A pilot trial was conducted at recommended phase 2 dosing (RP2D) using the bimonthly schedule to assess preferential uptake of CRLX101 in tumor vs. adjacent normal tissue in endoscopically accessible tumors in chemotherapy-refractory gastroesophageal cancer. Results from the biopsies were previously reported and herein we present the clinical outcomes. Patients initiated CRLX101 dosed at RP2D (15 mg/m2) on days 1 and 15 of a 28-day cycle. Detection of preferential CRLX101 tumor uptake was the primary endpoint and objective response rate (ORR) was a secondary endpoint. With a sample size of ten patients, the study had 90% power to detect ≥1 responder if the true response rate is ≥21%. Between Dec. 2012 and Dec. 2014, ten patients with chemotherapy-refractory (median 2 prior lines of therapy, range 1-4) gastric adenocarcinoma were enrolled. The median time-to-progression was 1.7 months. Best response was seen in one patient with stable disease (SD) for 8 cycles. Only ≥ grade 3 drug-related toxicity occurre...Continue Reading

Citations

Mar 31, 2019·Molecular Cancer·Nancy T CheeShaun P Brothers
May 10, 2019·Expert Opinion on Drug Discovery·Najah AlbadariWei Li
Dec 13, 2017·Clinical and Translational Medicine·Stephanie TranPrakash Rai
Jan 8, 2021·Frontiers in Immunology·Wei LiMin Cui
Nov 28, 2020·International Journal of Nanomedicine·Madhusmita Dhupal, Devasish Chowdhury

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