Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or in Combination With Capecitabine in Metastatic Hormone Receptor Positive Breast Cancer
GEN602
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
1 other identifier
interventional
127
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2019
Longer than P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2018
CompletedFirst Posted
Study publicly available on registry
December 14, 2018
CompletedStudy Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedDecember 23, 2022
December 1, 2022
4.2 years
December 6, 2018
December 22, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
maximum tolerated dose (MTD)
As assessed by CTCAE v4.03
18 months
Recommended dose of GZ17-6.02 for future phase II clinical studies
18 months
Dose-limiting toxicity
18 months
Secondary Outcomes (7)
Antitumor effect
18 months
Area Under Concentration Curve
18 months
Maximum Plasma Concentration (Cmax)
18 months
Time to Maximum Plasma Concentration (Tmax)
18 months
Terminal Phase Half-Life (t1/2)
18 months
- +2 more secondary outcomes
Study Arms (3)
Experimental: monotherapy
EXPERIMENTALGZ17-6.02 given orally on a daily x 28 day schedule. This will be a dose escalation study.
Experimental: Combination with Capecitabine in Metastatic Hormone Receptor Positive Breast Cancer
EXPERIMENTALGZ17-6.02 given orally twice daily x 21 day schedule in combination with Capecitabine 825 mg/m2 orally twice daily for 14 days x 21 day schedule.
Experimental: Combination with Capecitabine in Metastatic Colorectal Cancer
EXPERIMENTALGZ17-6.02 given orally twice daily x 21 day schedule in combination with Capecitabine 850 mg/m2 orally twice daily for 14 days x 21 day schedule.
Interventions
Super enhancer Inhibition
antimetabolite
Eligibility Criteria
You may qualify if:
- 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
- +21 more criteria
You may not qualify if:
- 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;
- 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.
- Patients who are currently receiving any other investigational agent;
- 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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genzada Pharmaceuticals USA, Inc.lead
- Translational Drug Developmentcollaborator
Study Sites (4)
HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Related Publications (1)
Booth L, West C, Von Hoff D, Dent P. Mechanisms of GZ17-6.02 resistance. Anticancer Drugs. 2022 Jun 1;33(5):415-423. doi: 10.1097/CAD.0000000000001203.
PMID: 35276694DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kathryn Gazarik
Translational Drug Development
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2018
First Posted
December 14, 2018
Study Start
March 1, 2019
Primary Completion
May 1, 2023
Study Completion
December 1, 2023
Last Updated
December 23, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share