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Monoclonal Antibodies
ZL-1211 for Solid Tumors
Phase 1 & 2
Recruiting
Research Sponsored by Zai Biopharmaceutical (Suzhou) Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients from Phase I and Phase II are required to provide tumor tissue for CLDN18.2 IHC assessment, and only patients with CLDN18.2-positive tumors will be included in this study
Hematological function defined as: Absolute neutrophil count ≥ 1.5 × 109/L without growth factor support in the 2 weeks prior to screening, Platelet count ≥ 100 × 109/L without transfusion in the 2 weeks prior to screening, Hemoglobin ≥ 9 g/dL without transfusion in the 2 weeks prior to screening, Prothrombin time, international normalized ratio or/and activated partial thromboplastin time < 1.5 × ULN, Recovery, to Grade 0-1, from AEs related to prior anticancer therapy except alopecia, < Grade 2 sensory neuropathy, lymphopenia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 10 months
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 that standard treatments can't help may join this trial. They must have measurable disease, be in good physical condition (ECOG 0 or 1), and have normal organ function. Only those with CLDN18.2-positive tumors are eligible after tissue testing.Check my eligibility
What is being tested?
ZL-1211 is being tested for safety and effectiveness against solid tumors. This early-phase study involves increasing doses to find the right amount and then expanding to more patients to learn how well it works when given every two weeks by IV infusion.See study design
What are the potential side effects?
Possible side effects of ZL-1211 aren't detailed here but typically include reactions at the infusion site, fatigue, changes in blood counts, liver or kidney issues based on its pharmacological class.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is CLDN18.2 positive.
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My blood counts are within the required ranges and I've recovered from previous cancer treatment side effects.
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I am fully active or have some restrictions but can still care for myself.
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My advanced cancer is not responding to standard treatments.
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My kidney function is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 10 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 10 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I and Phase II: safety and tolerability
Phase I ：MTD or MAD
Secondary outcome measures
Phase I and Phase II: immunogenicity
Phase I and Phase II: pharmacokinetics (PK):AUC
Phase I and Phase II: pharmacokinetics (PK):CL
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ZL-1211 monotherapyExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Zai Biopharmaceutical (Suzhou) Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a lung condition like COPD or pulmonary fibrosis that causes symptoms.My tumor is CLDN18.2 positive.I haven't had major surgery in the last 4 weeks or minor surgery in the last 2 weeks.My advanced cancer is not responding to standard treatments.I have never received CLDN18.2 antibody or CAR T cell therapy.I haven't had cancer treatment or radiation within the last 4 weeks or less.I have not taken any immune-weakening medications, including steroids, in the last 2 weeks.I am fully active or have some restrictions but can still care for myself.I have new or worsening brain metastases and may be taking seizure medication.My kidney function is within the normal range.I do not have current severe stomach or bowel problems.My blood counts are within the required ranges and I've recovered from previous cancer treatment side effects.I do not have severe heart disease or recent serious heart rhythm problems.I am 18 years old or older.I do not have HIV/AIDS or active/chronic hepatitis B or C.I do not have any ongoing infections that aren't being treated.My liver tests are within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: ZL-1211 monotherapy
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.
How many participants are included in the current research endeavor?
"The total number of candidates meeting the trial's criteria is 162. Zai Biopharmaceutical (Suzhou) Co., Ltd. will be overseeing this study with enquiries being made at two separate locations: Zai Site 2020 in Hackensack, New jersey and Zai Lab Site 2011 in Nashville, Tennessee."
Answered by AI
How many locations have implemented this clinical trial?
"This medical study is currently being conducted at 13 different sites across the nation, including Hackensack, Nashville and Tacoma. If you wish to join this trial it may be beneficial to choose a facility close by in order to reduce travel requirements."
Answered by AI
Is admission to this research still open?
"Yes, the clinical trial is currently recruiting volunteers. It was originally announced on January 19th 2022 and has had its information revised as recently as November 23rd 2022."
Answered by AI
What are the aims of this investigation?
"Zai Biopharmaceutical (Suzhou) Co., Ltd., the trial sponsor, has reported that measuring safety and tolerability over a one-month period is the primary outcome. Additionally, secondary outcomes will be monitored including Ctrough, Area under Curve (AUC), and Maximum Serum Concentration (Cmax)."
Answered by AI
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