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

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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.

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.

Condition or disease Intervention/treatment Phase
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 Drug: GZ17-6.02 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Experimental: Experimental: monotherapy
GZ17-6.02 given orally on a daily x 28 day schedule. This will be a dose escalation study.
Drug: GZ17-6.02
Super enhancer Inhibition




Primary Outcome Measures :
  1. maximum tolerated dose (MTD) [ Time Frame: 18 months ]
    As assessed by CTCAE v4.03

  2. Recommended dose of GZ17-6.02 for future phase II clinical studies [ Time Frame: 18 months ]
  3. Dose-limiting toxicity [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Antitumor effect [ Time Frame: 18 months ]
  2. Area Under Concentration Curve [ Time Frame: 18 months ]
  3. Maximum Plasma Concentration (Cmax) [ Time Frame: 18 months ]
  4. Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 18 months ]
  5. Terminal Phase Half-Life (t1/2) [ Time Frame: 18 months ]
  6. Total Body Clearance (CL/F) [ Time Frame: 18 months ]
  7. Apparent Volume of Distribution (Vd/F) [ Time Frame: 18 months ]


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:

  • 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

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): NCT03775525


Contacts
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Contact: Cameron Wright, MS 602-358-8341 cwright@td2inc.com
Contact: MedInfo 620-204-7150 MedInfo@genzada.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, MSN, RN, AOCNS    480-323-1364    Joyce.schaffer@honorhealth.com   
Principal Investigator: Frank Tsai, MD         
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Jaime Richardson, RN    310-423-2133    cancer.trial.info@cshs.org   
Principal Investigator: Monica Mita, MD         
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Amanda Woolery       amanda.woolery@ochsner.org   
Principal Investigator: Marc Matrana, MD         
Sponsors and Collaborators
Genzada Pharmaceuticals USA, Inc.
Translational Drug Development
Investigators
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Study Director: Cameron Wright, MS Translational Drug Development

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Responsible Party: Genzada Pharmaceuticals USA, Inc.
ClinicalTrials.gov Identifier: NCT03775525     History of Changes
Other Study ID Numbers: GEN-602-CT-101
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Carcinoma
Carcinoma, Squamous Cell
Stomach Neoplasms
Lymphoma, T-Cell
Carcinoma, Basal Cell
Squamous Cell Carcinoma of Head and Neck
Lymphoma, T-Cell, Cutaneous
Colorectal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Site
Neoplasms, Squamous Cell
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases
Intestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Lymphoma, Non-Hodgkin
Neoplasms, Basal Cell
Head and Neck Neoplasms
Colonic Diseases