Clinical Trials /

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

NCT03775525

Description:

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.

Related Conditions:
  • Lymphoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or Lymphoma
  • 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

Clinical Trial IDs

  • ORG STUDY ID: GEN-602-CT-101
  • NCT ID: NCT03775525

Conditions

  • 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

Interventions

DrugSynonymsArms
GZ17-6.02Experimental: monotherapy

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Experimental: monotherapyExperimentalGZ17-6.02 given orally on a daily x 28 day schedule. This will be a dose escalation study.
  • GZ17-6.02

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:maximum tolerated dose (MTD)
Time Frame:18 months
Safety Issue:
Description:As assessed by CTCAE v4.03

Secondary Outcome Measures

Measure:Antitumor effect
Time Frame:18 months
Safety Issue:
Description:
Measure:Area Under Concentration Curve
Time Frame:18 months
Safety Issue:
Description:
Measure:Maximum Plasma Concentration (Cmax)
Time Frame:18 months
Safety Issue:
Description:
Measure:Time to Maximum Plasma Concentration (Tmax)
Time Frame:18 months
Safety Issue:
Description:
Measure:Terminal Phase Half-Life (t1/2)
Time Frame:18 months
Safety Issue:
Description:
Measure:Total Body Clearance (CL/F)
Time Frame:18 months
Safety Issue:
Description:
Measure:Apparent Volume of Distribution (Vd/F)
Time Frame:18 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Genzada Pharmaceuticals USA, Inc.

Last Updated

November 4, 2020