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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03507998
Other study ID # CGX1321-102
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date June 17, 2017
Est. completion date April 1, 2021

Study information

Verified date July 2020
Source Curegenix Inc.
Contact Peter Ding
Phone (86)020-32299929
Email pding@curegenix.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 39
Est. completion date April 1, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
CGX1321
CGX1321 capsules for oral administration

Locations

Country Name City State
China Beijing Cancer Hospital Beijing
China Cancer Institute and Hospital, Chinese Academy of Medical Sciences Beijing

Sponsors (2)

Lead Sponsor Collaborator
Curegenix Inc. Guangzhou Curegenix Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events and/or abnormal laboratory values that are related to treatment 21 months
Secondary CGX1321 maximum or peak concentration 30 days
Secondary CGX1321 minimum or trough concentration 30 days
Secondary CGX1321 time to maximum concentration 30 days
Secondary CGX1321 half life 30 days
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