Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or in Combination With Capecitabine in Metastatic Hormone Receptor Positive Breast Cancer (GEN602)

  • End date
    Dec 23, 2023
  • participants needed
  • sponsor
    Genzada Pharmaceuticals USA, Inc.
Updated on 23 May 2022
platelet count
renal function
treatment regimen
kidney function tests
chemotherapy regimen
solid tumors
cancer chemotherapy
antineoplastic agents
solid tumour
progesterone receptor
estrogen receptor
solid neoplasm
cancer drug
anticancer agents
kidney function test


This Phase I/Ib study is a Multicenter, Open-label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of GZ17-6.02 Monotherapy and in Combination with Capecitabine, Given Orally on a Daily Schedule in Patients with Advanced Solid Tumors or Lymphoma


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.

This study will determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of GZ17-6.02 monotherapy and in combination with standard-of-care oncology treatments and to establish the dose of GZ17-6.02 recommended for future monotherapy and combination therapies phase II oncology clinical studies.

Condition 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
Treatment Capecitabine, GZ17-6.02
Clinical Study IdentifierNCT03775525
SponsorGenzada Pharmaceuticals USA, Inc.
Last Modified on23 May 2022


Yes No Not Sure

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
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
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
For patients in the GZ17-6.02 plus capecitabine Phase 1b Expansion Cohort 2 (metastatic
breast cancer)
Pathologically confirmed diagnosis of HER2-negative and Hormone Receptor (HR)
(estrogen receptor [ER] and/or progesterone receptor)-positive metastatic breast
Had ≤ 1 prior treatment (not including neoadjuvant or adjuvant treatment)
Are naïve to capecitabine but not necessarily to fluorouracil (5 FU)
Eligible for standard-of-care treatment with capecitabine monotherapy
Patients in Expansion Cohort 2 with bone-only metastatic disease must have one or more
lytic or a mixed lytic-blastic lesions that can be assessed by computed tomography
(CT) scan or magnetic resonance imaging (MRI)
For patients in GZ17-6.02 plus capecitabine Phase 1b Expansion Cohort 3 (metastatic
colorectal cancer)
Pathologically confirmed diagnosis of metastatic colorectal cancer
Had ≤ 2 prior treatments (not including neoadjuvant or adjuvant treatment)
Are naïve to capecitabine but not necessarily to 5 FU
Eligible for standard-of-care treatment with capecitabine monotherapy

Exclusion Criteria

Currently taking MAOIs
Unwillingness or inability to comply with procedures required in this protocol
Patients who are currently receiving any other investigational agent
Primary Central Nervous System (CNS) malignancies
Patients requiring steroids for neurological signs and symptom stabilization
(All patients, unless otherwise specified)
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
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
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 1 month prior to study entry
Treatment with chemotherapy, targeted therapeutics (e.g. tyrosine kinase inhibitors
therapeutic antibodies, etc), or investigational therapies within 1 month, or 5
half-lives (whichever is shorter), prior to study entry (6 weeks for nitrosoureas or
mitomycin C). For radiopharmaceuticals, within 1 month unless hematopoietic recovery
has not returned to pretreatment baseline
Known active infection with HIV, HTLV-1, hepatitis B, hepatitis C or other chronic
viral infections that 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
Active CNS metastases requiring treatment or radiotherapy, or which have not been
confirmed stable on radiographic imaging for ≥30 days prior to C1D1
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
For patients in the GZ17-6.02 monotherapy Dose Escalation Cohort and patients in Expansion
Cohort 1
• Patients with cow's milk allergy or with galactosemia
Phase 1b Expansion Cohort 2 (metastatic breast cancer) and Expansion Cohort 3 (metastatic
colorectal cancer)
Any history of coronary artery disease is exclusionary; New York Heart Association
Class III or IV, cardiac disease, myocardial infarction within the past 6 months
unstable arrhythmia, or evidence of ischemia on the ECG
Any conditions or medications that are contraindicated with capecitabine dosing
Dihydropyrimidine dehydrogenase (DPD) deficiency
Known sensitivity to capecitabine or any of its components or to 5-FU
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
o This includes prior gastrointestinal surgery that would interfere with the oral drug
Malignancy other than metastatic breast cancer (Expansion Cohort 2) or metastatic
colorectal cancer (Expansion Cohort 3) that required therapy within the preceding 5
years, other than adequately treated
non-melanoma skin cancer or in situ cancer
another cancer that has a very low risk of interfering with the safety or
efficacy endpoints of the study, must be approved by the Sponsor medical team
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