Actively Recruiting
A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients With Advanced Solid Tumors
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2026-03-09
100
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating YL202, an antibody-drug conjugate targeting the HER3 protein, in patients with advanced solid tumors including non-small cell lung cancer, colorectal cancer, and cervical cancer. This multicenter, open-label phase II study in China aims to assess the efficacy, safety, and pharmacokinetics of YL202 in these patients who have received one to two prior lines of systemic therapy. The study includes two periods: dose exploration and dose expansion. Participants in the colorectal cancer group will be randomly assigned to one of two dose levels of YL202, which is given as an intravenous infusion over approximately one hour. The trial evaluates YL202's effects and monitors patients throughout these periods. Participants will be followed for up to about three years, with assessments including tumor response measured by objective response rate, progression-free survival, duration and depth of response, overall survival, and safety through adverse event monitoring. Tumor tissue samples and organ function tests will be collected, and patients must comply with scheduled visits and procedures during the study period.
CONDITIONS
Brief Title
A Study of YL202 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years or older at the time of informed consent
- Body mass index (BMI) between 18 and 32 kg/m2
- Histologically or cytologically confirmed advanced non-small cell lung cancer, colorectal cancer, cervical cancer, or other advanced solid tumors
- Have received 1-2 prior lines of systemic therapy for advanced or metastatic disease
- At least one measurable extracranial lesion according to RECIST v1.1
- Availability of archived or fresh tumor tissue samples
- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1
- Adequate organ and bone marrow function within 7 days before first dose
- Female participants of childbearing potential must agree to use highly effective contraception during and for at least 6 months after treatment; male participants must agree to similar contraception
- Expected survival of at least 3 months
- Able and willing to comply with study visits and procedures
You will not qualify if you...
- Prior treatment with drugs targeting HER3
- Intolerance to topoisomerase I inhibitors or ADC therapy containing them
- Participation in another interventional clinical study or insufficient washout from prior therapies
- Major surgery within 4 weeks prior to treatment or planned during the study
- Prior allogeneic bone marrow or solid organ transplantation
- Systemic steroids or immunosuppressive treatment within 2 weeks before treatment
- Live vaccine within 4 weeks prior to treatment or planned during the study
- Presence of meningeal metastasis, cancerous meningitis, brain metastasis, or spinal cord compression
- Uncontrolled or significant cardiovascular or pulmonary diseases
- Recent hepatic encephalopathy within 6 months
- Active or chronic corneal or significant eye disorders requiring treatment
- Diagnosed Gilbert's syndrome
- Symptomatic or unstable pleural, peritoneal, or pericardial effusions requiring repeated drainage
- Recent gastrointestinal perforation, fistula, or active gastrointestinal diseases causing bleeding risk
- Serious infection with grade 3 or higher severity
- Severe coagulopathy or bleeding risk diseases
- Uncontrolled diabetes mellitus
- HIV infection, positive syphilis antibody, or active hepatitis B or C infection
- History of other primary malignancies within 5 years except certain cured cancers
- Unresolved toxicity from prior anti-tumor therapy
- Severe hypersensitivity to study drug components or monoclonal antibodies
- Pregnant or lactating women
- Any condition interfering with informed consent, study participation, or interpretation of results 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 years
Participants receive intravenous infusions of YL202 as part of dose-exploration and dose-expansion periods to evaluate the drug's efficacy and safety.
Visits occur with each infusion; frequency depends on dosing schedule
Trial Site Locations
Total: 1 location
1
Hunan Provincial Tumor Hospital
Changsha, Hunan, China, 410006
Actively Recruiting
Research Team
Y
yongchang zhang, Ph.D.
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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