Actively Recruiting
A Study of YL202 in Patients With Advanced Solid Tumors
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2026-03-09
100
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in selected patients with advanced solid tumors.
CONDITIONS
Official Title
A Study of YL202 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years or older.
- Participants must voluntarily sign an informed consent form.
- Body mass index (BMI) must be between 18 and 32 kg/m2.
- Participants must have histologically or cytologically confirmed advanced non-squamous non-small cell lung cancer, colorectal cancer, cervical cancer, or other advanced solid tumors.
- Participants must have received 1 to 2 lines of systemic therapy for advanced or metastatic disease.
- At least one extracranial measurable lesion must be present according to RECIST v1.1 criteria.
- Archived or fresh tumor tissue samples must be available.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score must be 0 or 1.
- Organ and bone marrow functions must meet study requirements within 7 days before the first dose.
- Female participants of childbearing potential must agree to use highly effective contraception during the study and for at least 6 months after the last dose; male participants must also agree to use highly effective contraception during this period.
- Expected survival must be at least 3 months.
- Participants must be capable of and willing to comply with study visits and procedures.
You will not qualify if you...
- Prior treatment with any drug therapy targeting HER3.
- Prior intolerance to topoisomerase I inhibitors or antibody-drug conjugates containing these inhibitors.
- Participation in another clinical interventional study, except observational studies or follow-up periods.
- Insufficient washout period from previous anti-tumor therapy before starting this study.
- Major surgery within 4 weeks before the first dose or planned major surgery during the study.
- Prior allogeneic bone marrow or solid organ transplantation.
- Use of systemic steroids over prednisone 10 mg/day or immunosuppressive treatments within 2 weeks before first dose.
- Receipt of any live vaccine within 4 weeks before first dose or planned during the study.
- Presence of meningeal metastasis or cancerous meningitis.
- Brain metastasis or spinal cord compression.
- Uncontrolled or clinically significant cardiovascular disease.
- Significant complicated pulmonary disorders.
- History of hepatic encephalopathy within 6 months before first dose.
- Active or chronic corneal or other eye disorders requiring continuous treatment or interfering with monitoring.
- Diagnosis of Gilbert's syndrome.
- Symptomatic or unstable pleural, peritoneal, or pericardial effusions requiring repeated drainage.
- History of gastrointestinal perforation, fistula, or active gastrointestinal diseases causing hemorrhage or perforation within 6 months before first dose.
- Serious infection graded 3 or higher before first dose.
- Severe coagulopathy or diseases with bleeding risk.
- Uncontrolled diabetes mellitus.
- HIV infection; positive syphilis antibody and titer.
- Active hepatitis B or C infection.
- History of other primary malignancies within 5 years, except certain cured skin cancers or in-situ diseases.
- Unresolved toxicity from previous anti-tumor therapies.
- History of severe hypersensitivity to drug ingredients or monoclonal antibodies.
- Lactating women or women confirmed pregnant within 3 days before first dose.
- Any diseases or conditions that impair ability to consent, cooperate, or affect study results interpretation, including mental illness or substance abuse, as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hunan Provincial Tumor Hospital
Changsha, Hunan, China, 410006
Actively Recruiting
Research Team
Y
yongchang zhang, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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