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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzada Pharmaceuticals USA, Inc.
• Collaborator: Translational Drug Development

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.