Your session is about to expire
← Back to Search
Monoclonal Antibodies
ZZ06 for Solid Tumors
Phase 1
Recruiting
Led By Sanjay Goel, MD
Research Sponsored by Changchun Intellicrown Pharmaceutical Co. LTD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Eastern Cooperative Oncology Group performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 weeks
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective.
Who is the study for?
Adults over 18 with advanced solid tumors positive for EGFR, who've exhausted standard treatments or have none available. They must be relatively healthy, not pregnant, agree to use contraception, and can't have active brain metastases or recent heart attacks. Prior treatment targeting EGF within 6 months is a disqualifier.Check my eligibility
What is being tested?
The trial tests ZZ06's safety and effectiveness in treating EGFR-positive solid tumors. It aims to find the highest dose patients can tolerate without severe side effects while also studying how the drug behaves in the body and its impact on tumor size.See study design
What are the potential side effects?
Specific side effects of ZZ06 aren't listed but may include typical reactions to cancer drugs such as nausea, fatigue, skin reactions, blood count changes leading to increased infection risk or bleeding problems. Organ-specific inflammation could also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Select...
My blood, kidney, and liver tests meet the required health standards.
Select...
My cancer is EGFR positive and has worsened despite treatment or lacks a standard treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of abnormal laboratory test results
Physical Examination
ZZ06 AEs
Secondary outcome measures
PK parameters: Area under curve (AUC)
PK parameters: Clearance rate (CL)
PK parameters: Cmax
+2 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: ZZ06 1.00 mg/kg dose groupExperimental Treatment1 Intervention
ZZ06 1.00 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
Group II: ZZ06 0.70 mg/kg dose groupExperimental Treatment1 Intervention
ZZ06 0.70 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
Group III: ZZ06 0.39 mg/kg dose groupExperimental Treatment1 Intervention
ZZ06 0.39 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
Group IV: ZZ06 0.22 mg/kg dose groupExperimental Treatment1 Intervention
ZZ06 0.22 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
Group V: ZZ06 0.12 mg/kg dose groupExperimental Treatment1 Intervention
ZZ06 0.12 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
Group VI: ZZ06 0.06 mg/kg dose groupExperimental Treatment1 Intervention
ZZ06 0.06 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
Group VII: ZZ06 0.03 mg/kg dose groupExperimental Treatment1 Intervention
ZZ06 0.03 mg/kg will be administered twice weekly.A cycle is defined as continuous treatment for 28 days, and the initial treatment course is 2 cycles. Patients can receive up to 6 additional cycles unless disease progression, unacceptable toxicity, or other protocol specified stopping criteria occur. After 6 cycles, additional cycles may be given upon request by the Investigator and approval by the Medical Monitor.
Find a Location
Who is running the clinical trial?
Changchun Intellicrown Pharmaceutical Co. LTDLead Sponsor
2 Previous Clinical Trials
177 Total Patients Enrolled
CovanceIndustry Sponsor
119 Previous Clinical Trials
12,756 Total Patients Enrolled
Sanjay Goel, MDPrincipal InvestigatorMontefiore Medical Center
1 Previous Clinical Trials
6 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had major surgery less than 4 weeks ago.I have a serious heart condition.I am 18 years old or older.I have a sample of my tumor available for EGFR testing.My brain metastases are stable for 4 weeks without needing steroids or seizure medicine.I am not pregnant or breastfeeding and agree to use birth control.I am fully active or can carry out light work.I have had another type of cancer within the last 3 years.I do not have any serious ongoing infections.My blood, kidney, and liver tests meet the required health standards.My cancer is EGFR positive and has worsened despite treatment or lacks a standard treatment.I have been treated with EGF pathway therapies within the last 6 months.I haven't taken any cancer treatment or experimental drugs for other conditions in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: ZZ06 0.22 mg/kg dose group
- Group 2: ZZ06 0.39 mg/kg dose group
- Group 3: ZZ06 0.06 mg/kg dose group
- Group 4: ZZ06 0.03 mg/kg dose group
- Group 5: ZZ06 0.12 mg/kg dose group
- Group 6: ZZ06 0.70 mg/kg dose group
- Group 7: ZZ06 1.00 mg/kg dose group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Share this study with friends
Copy Link
Messenger