Your session is about to expire
← Back to Search
Other
ZL-1218 + Pembrolizumab for Advanced Cancer
Phase 1
Recruiting
Research Sponsored by Zai Lab (Hong Kong), Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study Summary
This trial studies the effectiveness and safety of a drug to treat advanced solid tumors.
Who is the study for?
Adults with advanced solid tumors that can't be surgically removed or have spread, and who haven't responded to standard treatments or can't tolerate them. Participants need to be in fairly good health (ECOG 0-1), have a measurable tumor not previously treated with radiation, and agree to biopsies. They shouldn't have had recent vaccines, heart issues, cancer treatments within the last month, major surgery within four weeks, active lung inflammation not caused by infection, uncontrolled brain metastasis or infections needing antibiotics.Check my eligibility
What is being tested?
The trial is testing ZL-1218 alone and combined with Pembrolizumab on patients with various types of advanced cancers. It aims to understand how safe these drugs are when used together or separately, how they affect the body (pharmacokinetics/dynamics), and their initial effectiveness against tumors.See study design
What are the potential side effects?
Potential side effects for ZL-1218 and Pembrolizumab may include reactions at the infusion site, changes in immune system function leading to inflammation in different parts of the body including lungs (pneumonitis), fatigue, possible impact on liver enzymes which could indicate liver injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinically Significant changes in safety assessments
Incidence of Dose Limiting Toxicities
Incidence of Serious adverse events
+1 moreSecondary outcome measures
DCR per RECIST 1.1
DCR per iRECIST
Duration of Response per RECIST 1.1
+14 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Part 2: Cohort Expansion; Prior CPI TherapyExperimental Treatment2 Interventions
Drug: ZL-1218 ZL-1218 recommended dose
Drug: Pembrolizumab (KEYTRUDA®) Combination treatment with ZL-1218
Group II: Part 2: Cohort Expansion; CPI therapy NaiveExperimental Treatment2 Interventions
Drug: ZL-1218 ZL-1218 recommended dose
Drug: Pembrolizumab (KEYTRUDA®) Combination treatment with ZL-1218
Group III: Part 1: Dose Escalation; ZL-1218 in combination with PembrolizumabExperimental Treatment2 Interventions
Drug: ZL-1218 ZL-1218 dose escalation
Drug: Pembrolizumab (KEYTRUDA®) Combination treatment with ZL-1218
Group IV: Part 1: Dose Escalation; ZL-1218Experimental Treatment1 Intervention
Drug: ZL-1218 ZL-1218 dose escalation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Zai Biopharmaceutical (Shanghai) Co., Ltd.UNKNOWN
Zai Lab (Hong Kong), Ltd.Lead Sponsor
2 Previous Clinical Trials
350 Total Patients Enrolled
Zai Biopharmaceutical (Suzhou) Co., Ltd.Industry Sponsor
1 Previous Clinical Trials
162 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.I haven't had any cancer treatments in the last 4 weeks.I have a history of lung inflammation not caused by an infection.My advanced cancer is not responding to standard treatments, or I can't tolerate them.I am fully active or can carry out light work.I haven't had radiotherapy for non-pain reasons in the last 2 weeks or suffered from lung inflammation due to radiation.I am an adult over 18 years old or meet my local age of majority.I have had heart problems or significant heart disease in the last 3 months.I have brain metastasis that needs treatment.My cancer area hasn't been treated with radiation and is safe for a biopsy. I agree to have biopsies as required.I have not had major surgery in the last 4 weeks.I have never been treated with a CCR8 inhibitor and am not allergic to any study drug ingredients.I am currently on antibiotics for an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Cohort Expansion; Prior CPI Therapy
- Group 2: Part 1: Dose Escalation; ZL-1218 in combination with Pembrolizumab
- Group 3: Part 2: Cohort Expansion; CPI therapy Naive
- Group 4: Part 1: Dose Escalation; ZL-1218
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.
Is this experiment accepting any new participants at present?
"Current listings on clinicaltrials.gov show that this study is accepting participants, with the first post published on May 31st 2023 and the most recent update occurring on the 4th of May 2023."
Answered by AI
How many people are being recruited for participation in this investigation?
"Affirmative. Clinicaltrials.gov's data indicates that this medical research, which was first advertised on May 31st 2023, is actively seeking participants. Approximately 60 patients will be sourced from 3 different health institutions."
Answered by AI
What effects are researchers hoping to achieve through this clinical trial?
"This two-year clinical trial evaluates the rate of Treatment Related Adverse Events. Additionally, Objective Response Rate (ORR) per iRECIST, Duration of Response per RECIST 1.1, and Duration of Response per iRECIST are being measured as secondary objectives."
Answered by AI
Are there any potential hazards associated with the usage of ZL-1218?
"As this is only a Phase 1 trial, the safety of ZL-1218 has been tentatively assessed as level one on our scale due to insufficient data available."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger