A Phase I/Ib, 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

Genzada Pharmaceuticals USA, Inc.4 sites in 1 country127 target enrollmentMarch 1, 2019

Overview

Phase: Phase 1
Intervention: GZ17-6.02
Conditions: Advanced Cancer
Sponsor: Genzada Pharmaceuticals USA, Inc.
Enrollment: 127
Locations: 4
Primary Endpoint: maximum tolerated dose (MTD)
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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. 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.

Registry

clinicaltrials.gov

Start Date

March 1, 2019

End Date

December 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Genzada Pharmaceuticals USA, Inc.

Responsible Party

Sponsor

Eligibility 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

Exclusion Criteria

•(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.
•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 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;
•Unwillingness or inability to comply with procedures required in this protocol;