ZZ06 in Adult Patients With Advanced EGFR Positive Solid Tumor Malignancies
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ClinicalTrials.gov Identifier: NCT04412616 |
Recruitment Status :
Recruiting
First Posted : June 2, 2020
Last Update Posted : March 9, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced EGFR Positive Solid Tumor | Biological: ZZ06 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | September 1, 2020 |
Estimated Primary Completion Date : | June 1, 2022 |
Estimated Study Completion Date : | October 6, 2022 |
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.
|
Biological: ZZ06
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.
|
Biological: ZZ06
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.
|
Biological: ZZ06
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.
|
Biological: ZZ06
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.
|
Biological: ZZ06
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.
|
Biological: ZZ06
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.
|
Biological: ZZ06
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. |
- 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
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04412616
Contact: Shiqi Bai | 18943642700 | baishiqi@intelli-crown.com |
United States, California | |
Cedars Sinai Medical Center | Recruiting |
Los Angeles, California, United States, 90048-1804 | |
Contact: Monica Mita, MD | |
United States, Kansas | |
Kansas University Cancer Center | Recruiting |
Fairway, Kansas, United States, 66205-2528 | |
Contact: Joaquina Baranda, MD | |
United States, New York | |
Montefiore Medical Center | Recruiting |
Bronx, New York, United States, 90048-1804 | |
Contact: Sanjay Goel, MD | |
China, Jilin | |
Jilin Cancer Hospital | Not yet recruiting |
Changchun, Jilin, China, 130000 | |
Contact: Ying Cheng, BMed |
Principal Investigator: | Sanjay Goel, MD | Montefiore Medical Center |
Responsible Party: | Changchun Intellicrown Pharmaceutical Co. LTD |
ClinicalTrials.gov Identifier: | NCT04412616 |
Other Study ID Numbers: |
ZZ06-2020A |
First Posted: | June 2, 2020 Key Record Dates |
Last Update Posted: | March 9, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
treatment-emergent adverse event (TEAE) dose limiting toxicity (DLT) pharmacokinetic (PK) antidrug antibodies (ADA) |
Neoplasms |