Phase 1 Dose Escalation Study Of CGX1321 In Subjects With Advanced Gastrointestinal Tumors

Study Overview

Phase 1 Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors

This is a multi-center, open label, repeat dose, Phase 1 study consisting of a Dose Escalation Phase and a Dose Expansion Phase to evaluate safety, pharmacokinetics, and clinical activity.

The purpose of the Dose Escalation Phase is to examine the safety and determine the maximum tolerated dose of CGX1321 when administered to subjects with advanced GI tumors that have relapsed or are refractory to or not considered medically suitable to receive standard of care treatment. Once the dose is identified in the Dose Escalation Phase, the Dose Expansion Phase will start. The purpose of the Dose Expansion Phase is to continue to examine the safety and confirm the final Phase 2 dose of CGX1321 when administered to subjects with advanced GI tumors who meet the entry criteria.

Colorectal Adenocarcinoma
Gastric Adenocarcinoma
Pancreatic Adenocarcinoma
Bile Duct Carcinoma
Hepatocellular Carcinoma
Esophageal Carcinoma
Gastrointestinal Cancer

DRUG: CGX1321

CGX1321-102

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-04-16	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-07-22
First Submitted that Met QC Criteria 2018-04-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-07-24
First Posted (ACTUAL) 2018-04-25	Results First Posted N/A	Last Verified 2020-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: CGX1321 Dosing Dose Escalation Phase: Ascending doses of CGX1321 will be administered by cohort to determine the maximum tolerated dose. Patients will receive CGX1321, once daily, orally, for 3 weeks (21 days) followed by a one week (7 day) washout period in each 28 day	DRUG: CGX1321 CGX1321 capsules for oral administration

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: CGX1321 Dosing

Dose Escalation Phase: Ascending doses of CGX1321 will be administered by cohort to determine the maximum tolerated dose. Patients will receive CGX1321, once daily, orally, for 3 weeks (21 days) followed by a one week (7 day) washout period in each 28 day

DRUG: CGX1321

CGX1321 capsules for oral administration

Primary Outcome Measures	Measure Description	Time Frame
Number of participants with adverse events and/or abnormal laboratory values that are related to treatment		21 months

Secondary Outcome Measures	Measure Description	Time Frame
CGX1321 maximum or peak concentration		30 days
CGX1321 minimum or trough concentration		30 days
CGX1321 time to maximum concentration		30 days
CGX1321 half life		30 days

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Peter Ding

Phone Number: (86)020-32299929

Email: pding@curegenix.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically-diagnosed advanced Gl tumors, such as colorectal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, bile duct carcinoma, hepatocellular carcinoma, esophageal carcinoma that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment
Eastern Cooperative Oncology Group (ECOG) score of 0 - 1
Minimum estimated life expectancy of 3 months
Adequate organ function
Recovery from prior treatment-related toxicities
Ability to swallow capsules
Willingness for subjects of reproductive potential to use adequate methods of contraception during and for 3 months after study treatment

Prior exposure to a WNT inhibitor
Received previous therapy for malignancy within 21 days
Major surgery within 4 weeks of first dose of study drug
Radiotherapy within 2 weeks of first dose of study drug
Significant GI or variceal bleeding or subdural hematoma within 3 months of treatment start
Uncontrolled central nervous system metastases or leptomeningeal metastases
Requirement for immunosuppressive agents (must be off for at least 7 days)
Currently receiving medications that are known CYP3A4/5 inhibitors. Patients currently receiving medications of known inducers of CYP3A4/5 or substrates of CYP2C8/9 and CYP1A2 may be excluded.
Bone abnormalities
Hypercalcemia
Cardiac abnormalities
Known human immunodeficiency virus positive, or active hepatitis A, B or C
History of additional prior malignancy with the exception of surgically cured carcinomas such as skin, prostate, bladder, thyroid, cervix or other carcinomas in situ
Active systemic infection requiring intravenous antibiotics within 2 weeks of treatment start
Pregnancy or lactation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Guangzhou Curegenix Co. Ltd.

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record