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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02675946
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
Merck, Sharpe and Dohme Corporation
Information provided by (Responsible Party):
Curegenix Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumors GI Cancer Drug: CGX1321 Drug: Pembrolizumab Phase 1

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.

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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: CGX1321
Drug: Pembrolizumab
Other Name: Keytruda




Primary Outcome Measures :
  1. Number of participants with adverse events and/or abnormal laboratory values that are related to treatment [ Time Frame: 55 months ]

Secondary Outcome Measures :
  1. CGX1321 area under the curve [ Time Frame: 30 Days ]
  2. CGX1321 maximum or peak concentration [ Time Frame: 30 Days ]
  3. CGX1321 minimum or trough concentration [ Time Frame: 30 Days ]
  4. CGX1321 time to maximum concentration [ Time Frame: 30 Days ]
  5. CGX1321 half-life [ Time Frame: 30 Days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675946


Contacts
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Contact: Laurie Rosenstein rosensteinl@us.curegenix.com

Locations
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United States, Colorado
Sarah Cannon Research Institute at HealthONE Completed
Denver, Colorado, United States, 80218
United States, District of Columbia
Lombardi Comprehensive Cancer Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Jennifer Montcalm    202-687-8974    jem257@georgetown.edu   
Principal Investigator: Ben Weinstein, MD         
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Susan Sartorius-Mergenthaler, RN    410-614-3644    sartosu@jhmi.edu   
Contact: Jane Zorzi, RN    410-614-5818    jzorzi@jhmi.edu   
Principal Investigator: Dung Le, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Patricia Lynch, RN    617-643-0816    Lynch.Patricia2@mgh.harvard.edu   
Principal Investigator: Andrew Zhu, MD, PhD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: GI Research Line         
Contact    617-632-5960      
Principal Investigator: Marios Giannakis, MD, PhD         
United States, North Carolina
Duke Cancer Center, Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Terrance Lawrence    919-668-1861    Terrance.lawrence@duke.edu   
Principal Investigator: John Strickler, MD         
United States, Texas
START (South Texas Accelerated Research Therapeutics, LLC) Completed
San Antonio, Texas, United States, 78229
Taiwan
Taipei Medical University Hospital Completed
Taipei, Taiwan, 11031
Sponsors and Collaborators
Curegenix Inc.
Merck, Sharpe and Dohme Corporation
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Responsible Party: Curegenix Inc.
ClinicalTrials.gov Identifier: NCT02675946    
Other Study ID Numbers: CGX1321-101
MK3475-596 ( Other Identifier: Merck, Sharpe and Dohme Corporation )
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Curegenix Inc.:
WNT inhibitor
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents