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
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.
- 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
- 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
- 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
- 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
- Patients who are currently receiving any other investigational agent
- Patients with cow's milk protein allergy or with galactosemia