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YL202 for Cancer
Verified Trial
Phase 1
Recruiting
Research Sponsored by MediLink Therapeutics (Suzhou) Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged ≥18 years
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately within 36 months
Awards & highlights
Study Summary
This trial will test a new cancer drug for safety and effectiveness in patients with lung and breast cancer.
Who is the study for?
This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations, or hormone receptor-positive and HER2-negative breast cancer. Participants must have progressed after standard treatments, be able to use effective contraception, and not participate in other clinical studies. Major surgery within the last 4 weeks or need for systemic steroids disqualifies them.Check my eligibility
What is being tested?
YL202 is being tested in this phase 1 study on patients who have heavily treated NSCLC or breast cancer. The goal is to assess its safety and how well it's tolerated when given to individuals whose cancers are either locally advanced or have spread beyond their original site.See study design
What are the potential side effects?
While specific side effects of YL202 aren't listed, typical reactions may include discomfort at the injection site, fatigue, nausea, allergic reactions, and potential impacts on organ function due to its newness as a treatment option.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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I agree to use effective birth control and not donate eggs or sperm during and 6 months after the study.
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My lung cancer cannot be cured with surgery or radiation.
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My cancer has a specific EGFR mutation.
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My cancer has worsened or I can't tolerate the treatment after standard care.
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My breast cancer is advanced, cannot be surgically removed, and is HR-positive and HER2-negative.
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My cancer has worsened or I can't tolerate the treatment after standard care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately within 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately within 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment
Evaluate the occurrence of DLTs during the first cycle
Secondary outcome measures
Assess the incidence of anti-YL202 antibodies
Characterize the PK parameter AUC
Characterize the PK parameter CL
+7 moreOther outcome measures
Evaluate the duration of response (DoR)
Evaluate the overall survival (OS)
Evaluate the progression-free survival (PFS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: YL202 Dose escalationExperimental Treatment1 Intervention
YL202 will be administrated intravenously (IV) per dose level in which the patients are assigned.
Find a Location
Who is running the clinical trial?
MediLink Therapeutics (Suzhou) Co., Ltd.Lead Sponsor
4 Previous Clinical Trials
1,136 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer other than non-melanoma skin cancer or in situ disease in the past 3 years.I have not had major surgery in the last 4 weeks and do not expect any during the study.I have been diagnosed with Gilbert's syndrome.I agree to use effective birth control and not donate eggs or sperm during and 6 months after the study.My organs and bone marrow are working well.I can take care of myself and am up and about more than half of my waking hours.My cancer has a specific EGFR mutation.My cancer has worsened or I can't tolerate the treatment after standard care.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks, except for allowed types.You have experienced severe allergic reactions in the past to the drug, its ingredients, or similar drugs.You have a medical condition, mental illness or substance/alcohol abuse that may affect your ability to understand and sign the consent form, participate in the study or influence the study results.My breast cancer is advanced, cannot be surgically removed, and is HR-positive and HER2-negative.I don't have ongoing major side effects from cancer treatment, except for hair loss or skin color changes.My cancer has worsened or I can't tolerate the treatment after standard care.My lung cancer cannot be cured with surgery or radiation.I have had cancer spread to the lining of my brain and spinal cord.I have or had lung inflammation not caused by infection and needed steroids.I frequently need fluid drained from areas like my chest or abdomen.I do not have an active infection needing treatment within a week before starting the trial, or I am on preventive infection treatment.I am 18 years old or older.I do not have serious heart problems.I have a serious eye condition affecting the cornea.I have stomach or intestinal issues that could lead to bleeding or holes.I have had a bone marrow or organ transplant.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.I have a serious lung condition besides my cancer.I had severe side effects from previous cancer treatments like topotecan.I haven't had a long enough break from my last cancer treatment before starting the study drug.My brain or spinal tumors are stable without needing steroids or seizure meds for 2 weeks.You are expected to live for at least 3 more months.
Research Study Groups:
This trial has the following groups:- Group 1: YL202 Dose escalation
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.
Has the FDA granted authorization for an increasing concentration of YL202?
"Taking into consideration the Phase 1 status of YL202 Dose escalation, our team at Power reached a consensus that it is relatively safe with a score of 1."
Answered by AI
Is enrollment open for this scientific research study?
"According to the clinicaltrials.gov registry, this research project is currently open for participation and has been since December 20th 2022. The information was last updated on December 14th 2022."
Answered by AI
How many individuals are enrolled as part of this research project?
"Affirmative. Clinicaltrials.gov data clearly states that this scientific investigation, which was initially posted on December 20th 2022 is actively recruiting participants. In total 80 individuals need to be enrolled from a single medical facility."
Answered by AI
Who else is applying?
What site did they apply to?
BRCR Global
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I want try !
PatientReceived 1 prior treatment
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