ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies

Launched by CHANGCHUN INTELLICROWN PHARMACEUTICAL CO. LTD · Jun 1, 2020

Keywords

ClinConnect Summary

This clinical trial, called ZZ06, is looking at a new treatment for adults with advanced solid tumors that test positive for a protein called EGFR. This study is for patients who have already tried standard treatments but did not see improvement or have no other options available. The main goal of the trial is to find out how safe the new treatment is, what the best dose should be, and whether it can help shrink tumors.

To participate, patients must be at least 18 years old, have a confirmed diagnosis of an advanced EGFR-positive solid tumor, and have at least one measurable tumor. They will also need to provide a tissue sample from their tumor and meet certain health criteria, such as having stable organ function. Participants can expect close monitoring during the trial to assess how well they tolerate the treatment and to track any effects it may have on their tumors. It’s important for potential participants to discuss this opportunity with their doctors to see if it might be a good fit for their situation.

Gender

ALL

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.