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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
Must not have
Intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor, including but not limited to topotecan, irinotecan, and DXd (e.g., severe diarrhea)
Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately within 36 months
Awards & highlights
Summary
This trial is testing a new drug called YL202 to see if it is safe for patients with certain types of advanced lung and breast cancers that haven't responded to other treatments. The drug aims to target specific changes in the cancer cells to stop or slow their growth.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had severe side effects from previous cancer treatments like topotecan.
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I have not had major surgery in the last 4 weeks and do not expect any during the study.
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I have had a bone marrow or organ transplant.
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I have not received a live vaccine in the last 4 weeks and do not plan to during the study.
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I have had cancer spread to the lining of my brain and spinal cord.
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I do not have serious heart problems.
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I have or had lung inflammation not caused by infection and needed steroids.
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I have a serious lung condition besides my cancer.
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I have a serious eye condition affecting the cornea.
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I have been diagnosed with Gilbert's syndrome.
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I frequently need fluid drained from areas like my chest or abdomen.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Assess the incidence of anti-YL202 antibodies
Characterize the PK parameter AUC
Characterize the PK parameter CL
+7 moreOther study objectives
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.
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Who is running the clinical trial?
MediLink Therapeutics (Suzhou) Co., Ltd.Lead Sponsor
8 Previous Clinical Trials
1,885 Total Patients Enrolled
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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.
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