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

  • STATUS
    Recruiting
  • End date
    Dec 26, 2022
  • participants needed
    72
  • sponsor
    Curegenix Inc.
Updated on 26 January 2021
measurable disease
pembrolizumab
solid tumour

Summary

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.

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.

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)

Details
Condition Gastrointestinal Neoplasm, Bile duct carcinoma, HEPATOCELLULAR CARCINOMA, Solid Tumors, Pancreatic Adenocarcinoma, Esophageal Carcinoma, Gastric Adenocarcinoma, Solid Neoplasm, Colorectal Adenocarcinoma, Solid Tumour, gastrointestinal cancer, gastrointestinal cancers
Treatment Pembrolizumab, CGX1321
Clinical Study IdentifierNCT02675946
SponsorCuregenix Inc.
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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