Actively Recruiting
ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies
Led by Changchun Intellicrown Pharmaceutical Co. LTD · Updated on 2025-06-10
60
Participants Needed
5
Research Sites
304 weeks
Total Duration
On this page
Sponsors
C
Changchun Intellicrown Pharmaceutical Co. LTD
Lead Sponsor
C
Covance
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ZZ06 in Adult Patients With Advanced Solid Tumor Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced EGFR-positive solid tumor that progressed despite standard therapy or lacks standard therapy
- Archival tumor tissue available for EGFR status assessment using FDA-approved assay
- Age 18 years or older
- At least one measurable lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Adequate baseline organ function and laboratory values including bone marrow, coagulation, renal, and hepatic function
- Females not pregnant or lactating; males and females of childbearing potential agree to contraception
- Provided written informed consent prior to study procedures
You will not qualify if you...
- History of another primary cancer within 3 years except completely resected nonmelanoma skin cancer or carcinoma in situ of uterine cervix
- Active or symptomatic central nervous system metastases; stable treated CNS metastases allowed if stable for at least 4 weeks and no steroid or anticonvulsant treatment needed
- Positive tests for hepatitis C, hepatitis B, or HIV infection
- Active, clinically significant infections
- Significant cardiovascular disease including congestive heart failure (NYHA Class > 2), serious arrhythmia, myocardial infarction within 6 months, or unstable angina
- Previous significant allergic reaction to chimeric or murine monoclonal antibody therapy
- Prior treatment within 6 months with agents targeting the EGF pathway (e.g., cetuximab, panitumumab, gefitinib, erlotinib)
- Anticancer therapy or investigational agents for nonmalignant disease within 4 weeks or 5 half-lives before Cycle 1 Day 1, except tamoxifen for certain breast cancer history
- Major surgery within 4 weeks
- Clinically significant psychiatric illness, comorbidity, or lab abnormality that may interfere with safety or study compliance
- Other reasons deemed unsuitable for enrollment by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048-1804
Actively Recruiting
2
Kansas University Cancer Center
Fairway, Kansas, United States, 66205-2528
Actively Recruiting
3
Montefiore Medical Center
The Bronx, New York, United States, 90048-1804
Actively Recruiting
4
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Not Yet Recruiting
5
The first Bethune hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
Research Team
S
Shiqi Bai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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