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

Status: Active

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.

Eligibility Criteria

Inclusion Criteria

  • 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 that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment (Dose Expansion Phase)
  • Histologically-diagnosed advanced colorectal tumors that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment (Phase 1b)
  • Previous enrollment in Dose Escalation or Dose Expansion Phase with documented disease progression while on single agent CGX1321 (Roll-over Cohort)
  • Radiologically measurable disease
  • Minimum life expectancy of 3 months
  • Age 18 years or older
  • Adequate organ function
  • Recovery from prior treatment-related toxicities

Exclusion Criteria

  • Prior exposure to a WNT inhibitor (except Roll-over cohort)
  • Prior exposure to an anti-PD-1, anti-PD-L1 or anti-PD-L2
  • 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 the first dose of study drug
  • Known active central nervous system metastases and/or carcinomatous meningitis
  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
  • 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.
  • Osteoporosis (T-score of less than -2.5 by DEXA scan)
  • Bone metastases with prior history of pathologic fracture, lytic lesions requiring an orthopedic intervention, or not receiving bisphosphonates or denosumab
  • History of significant cardiac disease or uncontrolled hypertension
  • Known history of human immunodeficiency virus (HIV)
  • Known active hepatitis A, B or C
  • Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma that has undergone potentially curative therapy or in situ cervical cancer
  • Active systemic infection requiring intravenous antibiotics within 2 weeks of treatment start
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
  • Pregnancy or lactation
  • Has had an allogenic tissue/solid organ transplant

Locations & Contacts

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Contact: Jennifer Montcalm
Phone: 202-687-8974
Email: jem257@georgetown.edu

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available

Trial Objectives and Outline

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. The purpose of the Dose Expansion Phase, Roll-over Cohort and Phase 1b is to continue to examine the safety and confirm the final Phase 2 dose of CGX1321 alone in subjects with advanced GI tumors (Dose Expansion Phase) and evaluate the safety and tolerability of CGX1321 in combination with pembrolizumab (Phase 1b and Roll-over Cohort)

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Curegenix Inc.

Trial IDs

Primary ID CGX1321-101
Secondary IDs NCI-2018-00241
Clinicaltrials.gov ID NCT02675946