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Title:
J17143 - A Phase 1 Open-label Dose Escalation and Dose Expansion Study of CGX1321 in Subjects with Advanced Solid Tumors and Phase 1b Study of CGX1321 in Combination with Pembrolizumab in Subjects with Advanced Gastrointestinal Tumors
Protocol Number:
J17143
Phase:
Phase I
Physician:
Dung Le
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
Evaluate the safety and tolerability of CGX1321 as a single agent in subjects with advanced solid tumors, including GI tumors Evaluate the safety and tolerability of CGX1321 in combination with pembrolizumab in subjects with histologically-diagnosed colorectal tumors that are mismatch repair-proficient or microsatellite stable .
Eligibility:
Eligibility 1. Histologically-diagnosed advanced GI tumors, such as colorectal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, bile duct carcinoma, hepatocellular carcinoma, esophageal carcinoma in subjects that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment. Subjects must have confirmed genetic alterations (e.g., Rspo2 fusion, Rspo3 fusion or predicted loss-of-function mutations in RNF43) 2.Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST).3.Must have adequate organ function.4.Ability to swallow capsules5.Females and males of childbearing potential must agree to adequate methods of contraception.6.No prior exposure to WNT inhibitors or receiving medications known to be inhibitors of CYP2A4/5
Treatment:
This is a phase I study that will evaluate the effectiveness of CGX1321 as a single agent and CGX1321in combination with Pembrolizumab. CGX1321 is an oral pill and Pembrolizumab will be given IV
Population:
Adult
Last Update
03/05/2019 05:03 AM