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 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
      
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

July 26, 2019