ZZ06 for adults with advanced EGFR‑positive solid tumors

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

This trial will test whether the drug ZZ06 is safe and can control tumor growth in adults with advanced EGFR‑positive solid tumors who have no standard treatment options.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Changchun Intellicrown Pharmaceutical Co. LTD (Industry-sponsored)
• Drugs / interventions: cetuximab, panitumomab, erlotinib
• Locations: 5 sites (Los Angeles, California and 4 other locations)
• Trial ID: NCT04412616 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (age ≥18) with histologically or cytologically confirmed advanced EGFR‑positive solid tumors, measurable disease, ECOG performance status 0–1, adequate organ function, and archival tumor tissue available for EGFR testing are the intended participants.

Not a fit: Patients with tumors that are not EGFR‑positive, ECOG ≥2, inadequate organ or marrow function, or those who have effective standard treatment options are unlikely to benefit from this Phase 1 study.

Why it matters

Potential benefit: If successful, ZZ06 could provide a new treatment option that helps control tumor growth for patients with EGFR‑positive advanced solid tumors who have exhausted standard therapies.

How similar studies have performed: EGFR‑targeted therapies have shown benefit in specific tumor types, but ZZ06 is a novel agent and its safety and activity are unproven in humans beyond early-phase testing.

Eligibility criteria

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 this trial is running

Los Angeles, California and 4 other locations

• 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)
• Jilin Cancer Hospital — Changchun, Jilin, China (Not_yet_recruiting)
• The first Bethune hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Principal investigator: Sanjay Goel, MD — Montefiore Medical Center
• Study coordinator: Shiqi Bai

Conditions Advanced EGFR Positive Solid Tumor; treatment-emergent adverse event; dose limiting toxicity; pharmacokinetic; antidrug antibodies