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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 : April 26, 2021
Sponsor:
Collaborator:
Translational Drug Development
Information provided by (Responsible Party):
Genzada Pharmaceuticals USA, Inc.

Study Description
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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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: N/A
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 : May 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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 a pathologically confirmed diagnosis of advanced solid tumors or lymphoma.
  • Tumor progression after receiving standard/approved therapies which may include chemotherapy, targeted agents, radio-immuno conjugates, check point inhibitors, where there is no approved therapy; or the patient is intolerant of standard of care or the patient declines standard of care treatment
  • One or more metastatic tumors measurable, or evaluable, per RECIST v1.1 Criteria for solid tumors and Lugano Criteria for lymphoma
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Life expectancy of at least 3 months
  • Age 18 years
  • 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 (if liver metastases are present, then ≤ 5 x ULN is allowed)

  • Acceptable renal function:

    o Serum creatinine ≤ 1.5 times institutional ULN, 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:

    o No clinically significant abnormalities

  • Acceptable coagulation status (for patients on warfarin or other anti-coagulants, a PT/PTT considered by the PI as therapeutically appropriate will be allowed):

    • 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
  • Fasting glucose ≤ 180 mg/dL
  • Albumin ≥ 3.0 g/dL within seven days of initiating protocol treatment

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 in males, 470 msec in females, (using the Fridericia'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 or surgery within one month prior to study entry.
  • Treatment with chemotherapy, targeted therapeutics (e.g. tyrosine kinase inhibitors, therapeutic antibodies, etc.) or investigational therapies within one month, or 5 half-lives (whichever is shorter), prior to study entry (6 weeks for nitrosoureas or Mitomycin C). For radiopharmaceuticals, within one month unless hematopoietic recovery has not returned to pretreatment baseline.
  • 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
  • Primary Central Nervous System (CNS) malignancies
  • Active CNS metastases requiring treatment or radiotherapy, or which have not been confirmed stable on radiographic imaging for ≥30 days prior to C1D1
  • Patients requiring steroids for neurological signs and symptom stabilization
  • Patients who are unable to successfully discontinue all prohibited medications listed in Appendix 6
  • Patients must not have received a transfusion (platelets or red blood cells) ≤ 2 weeks prior to initiating protocol therapy.
Contacts and Locations
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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: Kathryn Gazarik 602-358-8336 kgazarik@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: Kathryn Gazarik Translational Drug Development
More Information
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Responsible Party: Genzada Pharmaceuticals USA, Inc.
ClinicalTrials.gov Identifier: NCT03775525    
Other Study ID Numbers: GEN-602-CT-101
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: November 2020
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
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Basal Cell
Lymphoma, T-Cell, Cutaneous
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
Lymphoma, Non-Hodgkin
Head and Neck Neoplasms
Neoplasms, Basal Cell