Actively Recruiting
A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2025-02-24
162
Participants Needed
30
Research Sites
314 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 1, multicenter, open-label stydy to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy in Selected Subjects with Advanced Solid Tumors conducted in China. The study will include 2 parts: a dose escalation part (Part 1) followed by a cohort expansion part (Part 2). Part 1 will estimate the safety, tolerability and MTD/RED(s) of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors. Part 2 will estimate the efficacy of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors.
CONDITIONS
Official Title
A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Voluntarily signed informed consent before study start
- Diagnosed with advanced solid tumors for dose-escalation phase (e.g., NPC, SCLC)
- Diagnosed with NPC, SCLC, NSCLC, or other advanced cancers for dose-expansion phase
- At least one measurable extracranial tumor lesion per RECIST v1.1
- Able to provide archived or fresh tumor tissue samples
- Organ and bone marrow functions meet requirements within 7 days before first dose
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Agree to use effective contraception if of childbearing potential during study and for 6 months after last dose
- Expected survival of 3 months or more
- Able and willing to comply with study visits and procedures
You will not qualify if you...
- Eligible for local radical treatment
- Previous drug therapy targeting B7H3
- Previous treatment with topoisomerase I inhibitors or antibody-drug conjugates containing them
- Prior treatment with anti-PD-(L)1, other immune checkpoint inhibitors, immune checkpoint agonists, or immunocellular therapies
- Unresolved toxicity from prior anticancer treatments
- Concurrent enrollment in another clinical study
- Inadequate washout period from prior anticancer therapy before first study drug dose
- Recent major surgery (excluding diagnostic) or serious trauma
- History of allogeneic stem cell or solid organ transplant
- Active autoimmune diseases requiring systemic treatment
- Use of systemic steroids
- Metastases to meninges or carcinomatous meningitis
- Brain metastases or spinal cord compression
- Uncontrolled or significant cardiovascular disease
- Significant concomitant lung disease
- Presence of uncontrolled third-space fluid
- History of gastrointestinal perforation or fistula within 6 months before first dose
- Serious infection prior to first dose
- Known HIV, hepatitis B, or hepatitis C infection
- Any other primary malignancy before first dose
- History of severe allergic reactions to investigational products or similar antibodies
- Women who are breastfeeding or pregnant confirmed by tests within 3 days before first dose
- Any illness, medical condition, organ dysfunction, or social situation that may interfere with the study
AI-Screening
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Trial Site Locations
Total: 30 locations
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijinig, China
Not Yet Recruiting
3
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
4
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
5
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Not Yet Recruiting
6
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Not Yet Recruiting
7
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
8
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
Actively Recruiting
9
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China
Not Yet Recruiting
10
The First Affiliated Hospital of Hainan Medical College
Haikou, Hainan, China
Not Yet Recruiting
11
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Not Yet Recruiting
12
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, China
Not Yet Recruiting
13
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
14
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
15
Hubei Provincial Cancer Hospital
Wuhan, Hubei, China
Not Yet Recruiting
16
Union Hospital Tongji Medical College HuaZhong University of Science Technology
Wuhan, Hubei, China
Actively Recruiting
17
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
18
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Actively Recruiting
19
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Actively Recruiting
20
The First Hospital of Jilin University
Changhua, Jilin, China
Not Yet Recruiting
21
Liaoning Provincial Cancer Hospital
Shenyang, Liaoning, China
Not Yet Recruiting
22
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Actively Recruiting
23
Linyi Central Hospital
Linyi, Shandong, China
Not Yet Recruiting
24
Zaozhuang Municipal Hospital
Zaozhuang, Shandong, China
Not Yet Recruiting
25
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Actively Recruiting
26
West China Hospital, Sichuan University
Sichuan, Sichuan, China
Actively Recruiting
27
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
28
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
29
Zhejiang Provincial Cancer Hospital
Hangzhou, Zhejiang, China
Not Yet Recruiting
30
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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