Clinical Trial - NCT02675946

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

Recruiting

Sponsor: Curegenix Inc.

Collaborators:

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02675946

Protocol Info

Short Description: Phase 1 of CGX1321 +/-Pembrolizumab in Advanced Gastrointestinal Tumors
Long Description: A Phase 1 Open-label Dose Escalation and Dose Expansion Study of CGX1321 in Subjects with Advanced Solid Tumors and Phase 1b Study of CGX1321 in Combination with Pembrolizumab in Subjects with Advanced Gastrointestinal Tumors
MGH Status: Open
Sponsor: Curegenix, Inc.
Disease Program: GI

Next Steps


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Purpose

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.
Condition Title Intervention Phase
Solid Tumors GI Cancer CGX1321 Pembrolizumab Phase 1
Study Type Interventional
Official Title A Phase 1 Open-label Dose Escalation and Dose Expansion Study of CGX1321 in Subjects With Advanced Solid Tumors and Phase 1b Study of CGX1321 in Combination With Pembrolizumab in Subjects With Advanced Gastrointestinal Tumors

Primary Outcome Measures

Number of participants with adverse events and/or abnormal laboratory values that are related to treatment [Time Frame: 55 months] [Designated as safety issue: ]


Secondary Outcome Measures

CGX1321 area under the curve [Time Frame: 30 Days] [Designated as safety issue: ]

CGX1321 maximum or peak concentration [Time Frame: 30 Days] [Designated as safety issue: ]

CGX1321 minimum or trough concentration [Time Frame: 30 Days] [Designated as safety issue: ]

CGX1321 time to maximum concentration [Time Frame: 30 Days] [Designated as safety issue: ]

CGX1321 half-life [Time Frame: 30 Days] [Designated as safety issue: ]

Estimated Enrollment: 72
Study Start Date: February 2016
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020
Arms Assigned Interventions

Experimental:CGX1321 alone and with pembrolizumab

Dose Escalation Phase: Ascending doses of CGX1321 once daily, orally, for 3 weeks (21 days) followed by a one-week (7-day) washout period in each 28-day cycle Dose Expansion Phase: CGX1321, at the MTD (identified in the Dose Escalation Phase), once daily, orally, for 3 weeks (21 days) followed by a one-week (7-day) washout period in each 28-day cycle. Roll-over Cohort: CGX1321 at a dose identified in Phase 1b, once daily, orally, for 2 weeks (14 days) followed by a one-week (7-day) washout period in combination with pembrolizumab administered IV once every three weeks (in each 21-day cycle). Phase 1b: Ascending doses of CGX1321, once daily, orally, for 2 weeks (14 days) followed by a one-week (7-day) washout period in combination with pembrolizumab administered IV once every three weeks (in each 21-day cycle).
Drug:Pembrolizumab

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02675946

Locations

  • United States, Colorado
    • Sarah Cannon Research Institute at HealthONE Denver, Colorado, United States, 80218
  • United States, District of Columbia
    • Lombardi Comprehensive Cancer Center Washington, District of Columbia, United States, 20007
  • United States, Maryland
    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland, United States, 21287
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
    • Dana-Farber Cancer Institute Boston, Massachusetts, United States, 02215
  • United States, North Carolina
    • Duke Cancer Center, Duke University Medical Center Durham, North Carolina, United States, 27710
  • United States, Texas
    • START (South Texas Accelerated Research Therapeutics, LLC) San Antonio, Texas, United States, 78229
  • Taiwan,
    • Taipei Medical University Hospital Taipei, , Taiwan, 11031

Sponsors and Collaborators

Curegenix Inc.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02675946
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Curegenix Inc.:

WNT inhibitor

Additional relevant MeSH terms:

Pembrolizumab

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on May 30, 2019