ZZ06 for adults with advanced EGFR‑positive solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, open-label, multicenter dose-escalation trial of ZZ06 in adults with advanced EGFR‑positive solid tumors who have progressed on or lack standard therapies. The study uses an initial accelerated-titration scheme for the first two cohorts followed by a conventional 3+3 escalation design to determine the maximum tolerated dose. Key outcomes include safety, dose-limiting toxicities, pharmacokinetics, immunogenicity, pharmacodynamics, and preliminary anti-tumor activity measured by RECIST v1.1. Eligible participants must have archival tumor tissue confirming EGFR positivity, at least one measurable lesion, ECOG 0–1, and adequate organ function.

Why it matters

Who can join: the full rules

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:

  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.

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:

  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.

Where it's running

• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Kansas University Cancer Center
  Fairway, Kansas, United States Recruiting
• Montefiore Medical Center
  The Bronx, New York, United States Recruiting
• The first Bethune hospital of Jilin University
  Changchun, Jilin, China Recruiting
• Jilin Cancer Hospital
  Changchun, Jilin, China Not yet recruiting

Study contacts

• Principal investigator: Sanjay Goel, MD — Montefiore Medical Center
• Study coordinator: Shiqi Bai
• Email: baishiqi@intelli-crown.com
• Phone: 18943642700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.