Description:
This is a multicenter, open-label study conducted in two phases: Phase 1 consisting of a
CGX1321 Single Agent Dose Escalation Phase in solid tumors, CGX1321 Single Agent Dose
Expansion Phase in GI tumors and Roll-over Cohort of CGX1321 and pembrolizumab in subjects
who have progressed on single agent CGX1321 and Phase 1b consisting of CGX1321 in combination
with pembrolizumab in colorectal tumors. Both phases are to evaluate safety,
pharmacokinetics, and clinical activity.
Title
- Brief Title: Study of CGX1321 in Subjects With Advanced Solid Tumors
- Official Title: A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CGX1321-101
- NCT ID:
NCT02675946
Conditions
- Solid Tumors
- Colorectal Adenocarcinoma
- Gastric Adenocarcinoma
- Pancreatic Adenocarcinoma
- Bile Duct Carcinoma
- Hepatocellular Carcinoma
- Esophageal Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
CGX1321 | | CGX1321 Oral Dosing |
Purpose
This is a multicenter, open-label, 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 solid tumors including
GI tumors that have relapsed or are refractory to or not considered medically suitable to
receive standard of care treatment who meet the entry criteria.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
CGX1321 Oral Dosing | Experimental | 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. | |
Eligibility Criteria
Inclusion Criteria:
Subjects must meet all of the following criteria to be eligible for the study:
- Pathologically-confirmed, locally advanced or metastatic solid tumors that have
relapsed or are refractory to or are not considered medically suitable to receive
standard of care treatment (Dose Escalation Phase)
- 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
(Dose Expansion Phase)
- Eastern Cooperative Oncology Group score of 0 - 2
- Minimum life expectancy of 3 months
- Age 18 years or older
- Adequate organ function
- Recovery from prior treatment-related toxicities
- Ability to swallow tablets
- Willingness for patients 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
- Bleeding disorder
- Bone abnormalities
- Uncontrolled central nervous system metastases or leptomeningeal metastases
- Requirement for immunosuppressive agents (must be off for at least 7 days)
- Currently receiving medications known to be inhibitors of CYP3A4/5. Subjects
currently receiving medications of known inducers of CYP3A4/5 or substrates of
CYP2C8/9 and CYP1A2 may be excluded.
- 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
- GI impairment that may compromise absorption of study drug
- Pregnancy or lactation
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of participants with adverse events and/or abnormal laboratory values that are related to treatment |
Time Frame: | 28 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | CGX1321 area under the curve |
Time Frame: | 30 Days |
Safety Issue: | |
Description: | |
Measure: | CGX1321 maximum or peak concentration |
Time Frame: | 30 Days |
Safety Issue: | |
Description: | |
Measure: | CGX1321 minimum or trough concentration |
Time Frame: | 30 Days |
Safety Issue: | |
Description: | |
Measure: | CGX1321 time to maximum concentration |
Time Frame: | 30 Days |
Safety Issue: | |
Description: | |
Measure: | CGX1321 half-life |
Time Frame: | 30 Days |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Curegenix Inc. |
Trial Keywords
Last Updated
February 20, 2017