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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
No Placebo-Only Group

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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~approximately within 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately within 36 months for reporting.

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 more
Other study objectives
Evaluate the duration of response (DoR)
Evaluate the overall survival (OS)
Evaluate the progression-free survival (PFS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
10 Previous Clinical Trials
2,723 Total Patients Enrolled

Media Library

YL202 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05653752 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: YL202 Dose escalation
Non-Small Cell Lung Cancer Clinical Trial 2023: YL202 Highlights & Side Effects. Trial Name: NCT05653752 — Phase 1
YL202 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05653752 — Phase 1
~0 spots leftby Dec 2024
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