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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03507998
Recruitment Status : Recruiting
First Posted : April 25, 2018
Last Update Posted : July 24, 2020
Guangzhou Curegenix Co. Ltd.
Information provided by (Responsible Party):
Curegenix Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Adenocarcinoma Gastric Adenocarcinoma Pancreatic Adenocarcinoma Bile Duct Carcinoma Hepatocellular Carcinoma Esophageal Carcinoma Gastrointestinal Cancer Drug: CGX1321 Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors
Actual Study Start Date : June 17, 2017
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

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 cycle, according to the cohort they are assigned.

Dose Expansion Phase: Patients will receive the recommended dose (identified in the Dose Expansion Phase) of CGX1321

Drug: CGX1321
CGX1321 capsules for oral administration

Primary Outcome Measures :
  1. Number of participants with adverse events and/or abnormal laboratory values that are related to treatment [ Time Frame: 21 months ]

Secondary Outcome Measures :
  1. CGX1321 maximum or peak concentration [ Time Frame: 30 days ]
  2. CGX1321 minimum or trough concentration [ Time Frame: 30 days ]
  3. CGX1321 time to maximum concentration [ Time Frame: 30 days ]
  4. CGX1321 half life [ Time Frame: 30 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03507998

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Contact: Peter Ding (86)020-32299929

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Beijing Cancer Hospital Recruiting
Beijing, China
Contact: Lin Shen, MD         
Contact: Jifang Gong    86 13683208528   
Cancer Institute and Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Aiping Zhou, MD         
Contact: Wen Zhang, MD    86 18611643302   
Sponsors and Collaborators
Curegenix Inc.
Guangzhou Curegenix Co. Ltd.
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Responsible Party: Curegenix Inc. Identifier: NCT03507998    
Other Study ID Numbers: CGX1321-102
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Esophageal Neoplasms
Digestive System Neoplasms
Carcinoma, Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Head and Neck Neoplasms
Esophageal Diseases
Neoplasms, Ductal, Lobular, and Medullary