Actively Recruiting
A Multi-center, Open-label, Phase I/II 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 I/II 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
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 36 months
Participants receive YL205 by intravenous infusion once every 3 weeks as a treatment cycle.
Visits every 3 weeks for treatment administration
Trial Site Locations
Total: 43 locations
1
Sarah Cannon Research Institute (SCRI)- Denver
Denver, Colorado, United States, 80218
Actively Recruiting
2
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
Florida Cancer Specialists - Lake Mary
Lake Mary, Florida, United States, 32746
Actively Recruiting
4
Norton Cancer Institute
Louisville, Kentucky, United States, 40241
Actively Recruiting
5
Washington University School of Medicine - Center for advanced Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
6
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, United States, 89169
Actively Recruiting
7
Southwest Women's Oncology
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
8
Stephenson Cancer Center (Oklahoma)
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
9
Providence Cancer Institute - Franz Clinic
Portland, Oregon, United States, 97213
Actively Recruiting
10
Sarah Cannon Research (SCRI)-Tennessee
Nashville, Texas, United States, 37203
Actively Recruiting
11
University of Washington
Seattle, Washington, United States, 98915
Actively Recruiting
12
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
13
Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University
Guangzhou, Guangdong, China
Actively Recruiting
14
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
15
Hainan General Hospital
Haikou, Hainan, China
Actively Recruiting
16
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Actively Recruiting
17
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Actively Recruiting
18
Anyang Cancer Hospital
Anyang, Henan, China
Actively Recruiting
19
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
20
Jingzhou First People's Hospital
Jingzhou, Hubei, China
Actively Recruiting
21
Hubei Cancer Hospital
Wuhan, Hubei, China
Actively Recruiting
22
Tongji Medical College of Hust TongJi Hospital
Wuhan, Hubei, China
Actively Recruiting
23
Union hospital Tongji Medical Colllege Huazhong University of School and Technology
Wuhan, Hubei, China
Actively Recruiting
24
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Actively Recruiting
25
Hunan Provincial Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
26
Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
27
Jilin Provincial Cancer Hospital
Changchun, Jilin, China
Actively Recruiting
28
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Actively Recruiting
29
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
Actively Recruiting
30
Central Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Actively Recruiting
31
Qilu Hospital of Shandong University
Jinan, Shandong, China
Actively Recruiting
32
Shandong Cancer Hospital
Jinan, Shandong, China
Actively Recruiting
33
Linyi Cancer Hospital
Linyi, Shandong, China
Actively Recruiting
34
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Actively Recruiting
35
The First Affiliated Hospital of XI'AN Jiaotong University
Xi’an, Shanxi, China
Actively Recruiting
36
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
37
Yunnan Cancer Hospital
Kunming, Yunnan, China
Actively Recruiting
38
The First Affiliated Hospital. Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
39
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
40
Chinese People's Liberation Army Army Characterstic Medical Center
Chongqing, China
Actively Recruiting
41
Chongqing Cancer Hospital
Chongqing, China
Actively Recruiting
42
The Southwest Hospital of AMU
Chongqing, China
Actively Recruiting
43
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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