Clinical Trials /

CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab in Subjects With Advanced GI Tumors (Keynote 596)

NCT02675946

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.

Related Conditions:
  • Colorectal Carcinoma
  • Gastrointestinal Stromal Tumor
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
CGX1321CGX1321 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

NameTypeDescriptionInterventions
CGX1321 Oral DosingExperimentalDose 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.
  • 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

  • WNT inhibitor

Last Updated

February 20, 2017