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ZZ06 for Advanced EGFR-Positive Solid Tumors

This study is testing a new treatment called ZZ06 for adults with advanced solid tumors that are positive for EGFR (Epidermal Growth Factor Receptor, a protein found on cancer cells). These are cancers that have continued to grow despite standard treatments, or for which no standard treatment exists. The main goals are to find a safe dose of ZZ06, understand its side effects, and see if it shows any early signs of helping to treat the cancer. To join, you must be at least 18 years old and have an advanced solid tumor that is EGFR positive. The study is currently unclear about its recruitment status.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know you are receiving ZZ06. It plans to enroll about 60 participants to find the best dose.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects and abnormal test results for up to 36 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04412616

ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies

Recruiting
PHASE1Ages 18+InterventionalTreatment
Changchun Intellicrown Pharmaceutical Co. LTD
~60 participants
Updated 2025-06-10 on ClinicalTrials.gov
What's tested:ZZ06

At a glance

Recruiting sites
4 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
ZZ06 AEs
Measured over up to 36 weeks
+2 more outcomes measured

Conditions

Advanced EGFR Positive Solid Tumor

Explore related trials

Solid NeoplasmSoluble Epidermal Growth Factor Receptor

NCT04412616

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cedars Sinai Medical Center

    Los Angeles, Californiano site contact published

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin, Chinano site contact published

    Not yet recruiting

  • Kansas University Cancer Center

    Fairway, Kansasno site contact published

    Recruiting

  • Montefiore Medical Center

    The Bronx, New Yorkno site contact published

    Recruiting

  • The first Bethune hospital of Jilin University

    Changchun, Jilin, Chinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Sanjay Goel, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

Who to contact

Shiqi Bai
[email protected]
18943642700
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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:
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

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:
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.

What this trial measures

  • ZZ06 AEsup 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 resultsup 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 findingsup to 36 weeks

    The data of the physical examinations is collected and analyzed according to the time point of the test flow chart