- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04412616
ZZ06 in Adult Patients With Advanced EGFR Positive Solid Tumor Malignancies
February 6, 2023 updated by: Changchun Intellicrown Pharmaceutical Co. LTD
A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Evidence of Antitumor Activity of ZZ06 in Adult Patients With Advanced EGFR Positive Solid Tumor Malignancies
This is a Phase 1, Multicenter, Open-label study to assess the safety, tolerability and preliminary efficacy of ZZ06 in participants with all Adult Patients with Advanced EGFR-positive Solid Tumor Malignancies who are not able to have current standard anti-tumor therapies.
The purpose of this study is to determine the maximum tolerated dose (MTD) , to characterise the safety, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activity of ZZ06 as a single agent in adult participants with advanced solid tumors.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The study will start with an accelerated-titration dose escalation scheme, enrolling 1 patient per cohort for the first 2 cohorts with expansion to 3 patients in the event of Grade ≥ 2 treatment-emergent adverse event (TEAE) or dose limiting toxicity (DLT) possibly, probably, or definitely related to the study drug.
After the first 2 cohorts, the study will then proceed to a 3+3 design, with enrollment of 3 patients per cohort and expansion to 6 patients in the event of a DLT.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jilin
-
Changchun, Jilin, China, 130000
- Not yet recruiting
- Jilin Cancer Hospital
-
-
-
-
California
-
Los Angeles, California, United States, 90048-1804
- Recruiting
- Cedars Sinai Medical Center
-
-
Kansas
-
Fairway, Kansas, United States, 66205-2528
- Recruiting
- Kansas University Cancer Center
-
-
New York
-
Bronx, New York, United States, 90048-1804
- Recruiting
- Montefiore Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with histologically or cytologically confirmed advanced solid tumor that is positive for EGFR and has progressed despite standard therapy or for whom no standard therapy exists.
- Patients are required to have archival tumor tissue available for assessment of EGFR status via FDA-approved EGFR assay .
- Age ≥ 18 years.
- Patients must have at least 1 measurable lesion as defined by RECIST v1.1.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Life expectancy ≥ 12 weeks.
Baseline organ function and laboratory data meet the following criteria:
- Bone marrow: ANC ≥ 1500 cells/mm3; Platelet count ≥ 75 000 cells/mm3; Hemoglobin ≥ 8.0 g/dL.
- Coagulation: Prothrombin time ≤ 1.5× ULN; Activated partial thromboplastin time ≤ 1.5× ULN;
- Renal function: Serum creatinine ≤ 1.5× ULN ; estimated glomerular filtration rate≥ 60 mL/min (Cockcroft-Gault formula).
- Hepatic function: Serum total bilirubin ≤ 1.5 mg/dL; AST and ALT ≤ 3.0× ULN (if metastases are present, ≤ 5.0× ULN).
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.Patients must provide written informed consent prior to any study procedures.
Exclusion Criteria:
- History of another primary cancer ≤ 3 years, with the exception of completely resected nonmelanoma skin cancer or carcinoma in situ of uterine cervix.
- Active or symptomatic CNS metastases. Patients with treated CNS metastases that have been stable for ≥ 4 weeks and do not require treatment with steroids or anticonvulsants may be enrolled at the discretion of the Investigator.
- Tests positive for hepatitis C virus, hepatitis B virus, or human immunodeficiency virus infection.
- Active, clinically significant infections.
Clinically significant cardiovascular disease, including any of the following:
- Congestive heart failure (New York Heart Association Class > 2).
- Serious cardiac arrhythmia.
- Myocardial infarction ≤ 6 months.
- Unstable angina.
- Prior clinically significant allergic reaction to chimerized or murine monoclonal antibody therapy.
- Prior treatment ≤ 6 months with cetuximab, panitumomab, gefitinb, erlotinib, or other therapy that specifically and directly targets the EGF pathway.
- Anticancer therapy or investigational agents for nonmalignant disease ≤ 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1, with the exception of tamoxifen for patients with a history of operated breast cancer > 3 years and no evidence of disease after surgery.
- Major surgery ≤ 4 weeks.
- Clinically significant psychiatric illness, other comorbidity, or laboratory abnormality that, in the opinion of the Investigator, makes it unsafe for the patient to participate in the study or may interfere with study compliance or study results.
- Other unspecified reasons that, in the opinion of the Investigator, make the patient unsuitable for enrollment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ZZ06 0.03 mg/kg dose group
ZZ06 0.03 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles.
Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur.
After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
|
The phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1
mg/kg.
|
EXPERIMENTAL: ZZ06 0.06 mg/kg dose group
ZZ06 0.06 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles.
Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur.
After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
|
The phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1
mg/kg.
|
EXPERIMENTAL: ZZ06 0.12 mg/kg dose group
ZZ06 0.12 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles.
Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur.
After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
|
The phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1
mg/kg.
|
EXPERIMENTAL: ZZ06 0.22 mg/kg dose group
ZZ06 0.22 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles.
Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur.
After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
|
The phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1
mg/kg.
|
EXPERIMENTAL: ZZ06 0.39 mg/kg dose group
ZZ06 0.39 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles.
Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur.
After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
|
The phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1
mg/kg.
|
EXPERIMENTAL: ZZ06 0.70 mg/kg dose group
ZZ06 0.70 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles.
Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur.
After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
|
The phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1
mg/kg.
|
EXPERIMENTAL: ZZ06 1.00 mg/kg dose group
ZZ06 1.00 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles.
Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur.
After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
|
The phase I "3 + 3" study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1
mg/kg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ZZ06 AEs
Time Frame: up to 36 weeks
|
Adverse events will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
|
up to 36 weeks
|
Incidence of abnormal laboratory test results
Time Frame: up to 36 weeks
|
The data of the clinical laboratory evaluation is collected and analyzed according to the time point of the test flow chart
|
up to 36 weeks
|
Incidence of abnormal physical exam findings
Time Frame: up to 36 weeks
|
The data of the physical examinations is collected and analyzed according to the time point of the test flow chart
|
up to 36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PK parameters: Area under curve (AUC)
Time Frame: up to 28 weeks
|
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
|
up to 28 weeks
|
PK parameters: Cmax
Time Frame: up to 28 weeks
|
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
|
up to 28 weeks
|
PK parameters: Clearance rate (CL)
Time Frame: up to 28 weeks
|
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
|
up to 28 weeks
|
PK parameters: t1/2
Time Frame: up to 28 weeks
|
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
|
up to 28 weeks
|
PK parameters: Vz
Time Frame: up to 28 weeks
|
According to the test schedule, the blood volume of each subject's PK was analyzed and PK analysis was performed.
|
up to 28 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2020
Primary Completion (ANTICIPATED)
December 1, 2023
Study Completion (ANTICIPATED)
April 6, 2024
Study Registration Dates
First Submitted
May 14, 2020
First Submitted That Met QC Criteria
June 1, 2020
First Posted (ACTUAL)
June 2, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 6, 2023
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZZ06-2020A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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