On November 17, 2023 CG Pharmaceuticals reported the commencement of Phase 2 study for metastatic pancreatic ductal adenocarcinoma (PDAC) with the recommended Phase 2 dose (RP2D) of ivaltinostat (ClinicalTrials.gov ID NCT05249101) (Press release, CrystalGenomics, NOV 17, 2023, View Source [SID1234637783]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The RP2D of ivaltinostat (250 mg/m2) was determined by the Safety Review Committee (SRC) following a thorough safety data review from 3 cohorts of increasing dose levels of ivaltinostat in combination with a fixed dose of capecitabine. The SRC has unanimously recommended proceeding to Phase 2, marking a significant milestone, effective immediately, the study is open for the enrollment of patients.
In Phase 2, metastatic PDAC patients who show no evidence of disease progression after an initial treatment with FOLFIRINOX will receive either combination therapy or capecitabine monotherapy. The primary endpoint is progression free survival.
Dr. Gene Cho, Vice President of Global Strategic Planning at CG Pharmaceuticals, expressed his excitement, "I am thrilled and honored to share this important study milestone and witness the commencement of Phase 2, with an enrollment target of 52 patients. We extend our heartfelt gratitude to our investigators, partners, and, most importantly, our patients for their invaluable participation in this critical study."
The study abstract has been accepted by the ASCO (Free ASCO Whitepaper) GI and will be presented on January 19, 2024, San Francisco, California.
About Ivaltinostat:
Ivaltinostat, a novel anticancer therapeutic candidate that inhibits enzymatic activity of histone deacetylase, has been evaluated for solid tumors and hematologic malignancies.