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

Primary Purpose

Colorectal Adenocarcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CGX1321
Sponsored by
Curegenix Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Cancer HospitalRecruiting
  • Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CGX1321 Dosing

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants with adverse events and/or abnormal laboratory values that are related to treatment

Secondary Outcome Measures

CGX1321 maximum or peak concentration
CGX1321 minimum or trough concentration
CGX1321 time to maximum concentration
CGX1321 half life

Full Information

First Posted
April 16, 2018
Last Updated
July 22, 2020
Sponsor
Curegenix Inc.
Collaborators
Guangzhou Curegenix Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03507998
Brief Title
Phase 1 Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors
Official Title
A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects With Advanced Gastrointestinal Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 17, 2017 (Actual)
Primary Completion Date
April 1, 2021 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Curegenix Inc.
Collaborators
Guangzhou Curegenix Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Adenocarcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma, Bile Duct Carcinoma, Hepatocellular Carcinoma, Esophageal Carcinoma, Gastrointestinal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CGX1321 Dosing
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
CGX1321
Intervention Description
CGX1321 capsules for oral administration
Primary Outcome Measure Information:
Title
Number of participants with adverse events and/or abnormal laboratory values that are related to treatment
Time Frame
21 months
Secondary Outcome Measure Information:
Title
CGX1321 maximum or peak concentration
Time Frame
30 days
Title
CGX1321 minimum or trough concentration
Time Frame
30 days
Title
CGX1321 time to maximum concentration
Time Frame
30 days
Title
CGX1321 half life
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Ding
Phone
(86)020-32299929
Email
pding@curegenix.com
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
First Name & Middle Initial & Last Name & Degree
Jifang Gong
Phone
86 13683208528
Email
goodjf@163.com
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiping Zhou, MD
First Name & Middle Initial & Last Name & Degree
Wen Zhang, MD
Phone
86 18611643302
Email
wenwen0605@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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