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Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or Lymphoma (GEN602)

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: NCT03775525
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
Translational Drug Development
Information provided by (Responsible Party):
Genzada Pharmaceuticals USA, Inc.

Tracking Information
First Submitted Date  ICMJE December 6, 2018
First Posted Date  ICMJE December 14, 2018
Last Update Posted Date July 30, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • maximum tolerated dose (MTD) [ Time Frame: 18 months ]
    As assessed by CTCAE v4.03
  • Recommended dose of GZ17-6.02 for future phase II clinical studies [ Time Frame: 18 months ]
  • Dose-limiting toxicity [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03775525 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • Antitumor effect [ Time Frame: 18 months ]
  • Area Under Concentration Curve [ Time Frame: 18 months ]
  • Maximum Plasma Concentration (Cmax) [ Time Frame: 18 months ]
  • Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 18 months ]
  • Terminal Phase Half-Life (t1/2) [ Time Frame: 18 months ]
  • Total Body Clearance (CL/F) [ Time Frame: 18 months ]
  • Apparent Volume of Distribution (Vd/F) [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or Lymphoma
Official Title  ICMJE A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GZ17-6.02 Given Orally on a Daily x 28 Day Schedule in Patients With Advanced Solid Tumors or Lymphoma
Brief Summary This study will evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a novel anti-cancer drug, GZ17-6.02 administered to patients with advanced solid tumors or lymphoma, which have progressed after receiving standard/approved therapy or where there is no approved therapy.
Detailed Description This Phase I study is an open-label, dose-escalation trial designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of the novel anti-cancer compound, GZ17-6.02. GZ17-6.02 is administered orally to patients with advanced solid tumors or lymphoma.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Gastric Cancer
  • Breast Cancer
  • Pancreatic Cancer
  • Prostate Cancer Metastatic
  • Colo-rectal Cancer
  • Solid Tumor
  • Solid Carcinoma
  • Solid Carcinoma of Stomach
  • Cancer of Stomach
  • Lymphoma
  • Sarcoma
  • Cutaneous T Cell Lymphoma
  • Head and Neck Squamous Cell Carcinoma
  • Basal Cell Carcinoma
  • Cutaneous T-cell Lymphoma
  • Cutaneous Squamous Cell Carcinoma
Intervention  ICMJE Drug: GZ17-6.02
Super enhancer Inhibition
Study Arms  ICMJE Experimental: Experimental: monotherapy
GZ17-6.02 given orally on a daily x 28 day schedule. This will be a dose escalation study.
Intervention: Drug: GZ17-6.02
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2018)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with histologically confirmed advanced solid tumors or lymphoma.
  • Tumor progression after receiving all standard/approved therapies which may include chemotherapy, targeted agents, radio-immuno conjugates, check point inhibitors or where there is no approved therapy
  • One or more metastatic tumors measurable per RECIST v1.1 Criteria for solid tumors and Lugano Criteria for lymphoma
  • Karnofsky performance ≥ 70%
  • Life expectancy of at least 3 months
  • Signed, written IRB-approved informed consent
  • A negative pregnancy test (if female)
  • Acceptable liver function:

    • Bilirubin ≤ 1.5 times upper limit of normal
    • AST (SGOT), ALT (SGPT) and Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN). If liver metastases are present, then ≤ 5 x ULN is allowed.
  • Acceptable renal function:

    • Serum creatinine within normal limits, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
  • Acceptable hematologic status:

    • Granulocyte ≥ 1500 cells/mm3
    • Platelet count ≥ 100,000 (plt/mm3)
    • Hemoglobin ≥ 9 g/dL
  • Urinalysis:

    • No clinically significant abnormalities
  • Acceptable coagulation status:

    • PT within ≤ 1.5 times normal limits
    • PTT within ≤ 1.5 times normal limits
  • For men and women of child-producing potential, the use of effective contraceptive methods during the study

Exclusion Criteria:

  • New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
  • Currently taking MAOIs
  • Baseline QTc exceeding 450 msec (using the Bazett's formula) and/or patients receiving class 1A or class III antiarrhythmic agents.
  • Known active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  • Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
  • Unwillingness or inability to comply with procedures required in this protocol
  • Known active infection with HIV, HTLV-1, hepatitis B, or hepatitis C or other chronic viral infections which could interfere with the interpretation of study data Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
  • Patients who are currently receiving any other investigational agent
  • Patients with cow's milk protein allergy or with galactosemia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cameron Wright, MS 602-358-8341 cwright@td2inc.com
Contact: MedInfo 620-204-7150 MedInfo@genzada.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03775525
Other Study ID Numbers  ICMJE GEN-602-CT-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Genzada Pharmaceuticals USA, Inc.
Study Sponsor  ICMJE Genzada Pharmaceuticals USA, Inc.
Collaborators  ICMJE Translational Drug Development
Investigators  ICMJE
Study Director: Cameron Wright, MS Translational Drug Development
PRS Account Genzada Pharmaceuticals USA, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP