Actively Recruiting
A Multi-center, Open-label, Phase III Study Evaluating Safety, Pharmacokinetics, and Preliminary Efficacy of YL205 in Patients With Advanced Solid Tumors
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2025-12-23
252
Participants Needed
43
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating YL205, a drug given by intravenous infusion, in patients with advanced solid tumors. This multicenter, open-label phase III study in China aims to assess the safety, tolerability, pharmacokinetics how the drug moves through the body, and preliminary effectiveness of YL205. Eligible patients have advanced solid tumors that overexpress Napi2B and include cancers such as ovarian, non-squamous non-small cell lung, renal cell, and endometrial cancer. Participants receive YL205 as a lyophilized powder reconstituted for intravenous infusion at a dose of 160 mg per vial. Treatment is given once every three weeks in cycles, with dose levels adjusted during different study phases dose escalation phase Ia, dose expansion phase Ib, and cohort expansion phase II. The study evaluates at least two dose levels and the recommended phase 2 dose RP2D. Throughout approximately 36 months, participants are closely monitored for dose-limiting toxicities, treatment-emergent adverse events, and serious adverse events. Researchers assess tumor response using RECIST v1.1 criteria, including overall response rate, disease control rate, duration and depth of response, progression-free survival, and overall survival. Pharmacokinetic parameters like AUC, Cmax, and half-life are also measured. Patients undergo tumor sampling and radiological evaluations to track treatment effects and safety.
CONDITIONS
Brief Title
A Clinical Study of YL205 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years or older
- Patients with histologically or cytologically confirmed advanced or metastatic ovarian cancer, non-squamous non-small cell lung cancer, renal cell carcinoma, endometrial cancer, or other tumors overexpressing Napi2B
- Positive Napi2B test result from a central laboratory
- At least one evaluable or measurable extracranial lesion depending on study part
- Expected survival of at least 3 months
- Female participants of childbearing potential agree to effective contraception and no egg donation from screening through 6 months after last dose
- Male participants agree to effective contraception and no sperm donation from screening through 6 months after last dose
- Body mass index between 18 and 32 kg/m2 and for females, body weight at least 45 kg
- Ability and willingness to comply with all study procedures and visits
- Signed informed consent form
You will not qualify if you...
- Previous treatment with drugs targeting Napi2b
- History of intolerance to topoisomerase I inhibitors or antibody-drug conjugate therapy
- Participation in another interventional clinical study or insufficient washout from prior anti-tumor therapy
- Radiotherapy or major surgery within 4 weeks prior to first dose or planned surgery during study
- Prior allogeneic bone marrow or solid organ transplantation
- Use of systemic steroids or immunosuppressants within 2 weeks prior to first dose
- Receipt of live vaccines within 4 weeks prior to first dose or planned during study
- History of leptomeningeal carcinoma, cancerous meningitis, brain metastasis, or spinal cord compression
- Uncontrolled or significant cardiovascular or cerebrovascular disease
- Diagnosis of Gilbert's syndrome
- Symptomatic or unstable third space effusions needing repeated drainage
- Recent gastrointestinal perforation, fistula, active ulcers, or other GI disorders causing bleeding or perforation
- Serious infections prior to first dose
- Active infections including HIV, hepatitis B or C, or positive syphilis test
- Unresolved toxicity from prior anti-tumor treatments
- History of serious allergic reactions to drugs or monoclonal antibodies
- Pregnancy or breastfeeding
- Other significant diseases, medical conditions, organ dysfunction, or social conditions
- Multiple primary malignancies within 5 years except certain treated skin cancers or solid tumors
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here