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 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.
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.