RECRUITING

ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies

Conditions

Advanced EGFR Positive Solid Tumor treatment-emergent adverse event (TEAE)dose limiting toxicity (DLT)pharmacokinetic (PK)antidrug antibodies (ADA)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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 Solid Tumor Malignancies

Quick Facts

Study Start:2020-09-01

Study Completion:2026-07-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04412616

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 1. Bone marrow： ANC ≥ 1500 cells/mm3； Platelet count ≥ 75 000 cells/mm3； Hemoglobin ≥ 8.0 g/dL. 2. Coagulation： Prothrombin time ≤ 1.5× ULN； Activated partial thromboplastin time ≤ 1.5× ULN； 3. Renal function： Serum creatinine ≤ 1.5× ULN ； estimated glomerular filtration rate≥ 60 mL/min (Cockcroft-Gault formula). 4. 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.	* 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: 1. Congestive heart failure (New York Heart Association Class \> 2). 2. Serious cardiac arrhythmia. 3. Myocardial infarction ≤ 6 months. 4. 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.

Inclusion Criteria

Exclusion 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:
1. Bone marrow： ANC ≥ 1500 cells/mm3； Platelet count ≥ 75 000 cells/mm3； Hemoglobin ≥ 8.0 g/dL.
2. Coagulation： Prothrombin time ≤ 1.5× ULN； Activated partial thromboplastin time ≤ 1.5× ULN；
3. Renal function： Serum creatinine ≤ 1.5× ULN ； estimated glomerular filtration rate≥ 60 mL/min (Cockcroft-Gault formula).
4. 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.

* 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:
1. Congestive heart failure (New York Heart Association Class \> 2).
2. Serious cardiac arrhythmia.
3. Myocardial infarction ≤ 6 months.
4. 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.

Contacts and Locations

Study Contact

Shiqi Bai

CONTACT

18943642700

baishiqi@intelli-crown.com

Principal Investigator

Sanjay Goel, MD

PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Study Locations (Sites)

Cedars Sinai Medical Center

Los Angeles, California, 90048-1804

United States

Kansas University Cancer Center

Fairway, Kansas, 66205-2528

United States

Montefiore Medical Center

Bronx, New York, 90048-1804

United States

Collaborators and Investigators

Sponsor: Changchun Intellicrown Pharmaceutical Co. LTD

Sanjay Goel, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

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 Registration Dates

Study Start Date2020-09-01

Study Completion Date2026-07-06

Study Record Updates

Study Start Date2020-09-01

Study Completion Date2026-07-06

Terms related to this study

Keywords Provided by Researchers

treatment-emergent adverse event (TEAE)
dose limiting toxicity (DLT)
pharmacokinetic (PK)
antidrug antibodies (ADA)

Additional Relevant MeSH Terms

Advanced EGFR Positive Solid Tumor