Actively Recruiting
A Study of YL201 in Patients With Advanced Solid Tumors
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2025-11-10
312
Participants Needed
45
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201 conducted in China and the United States. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2). Part 1 will estimate the MTD/RED(s) in dose escalation cohorts of patients with advanced solid tumors unresponsive to currently available therapies or for whom no standard therapy is available. Part 2 will include patients with selected advanced solid tumor types enrolled at the MTD/RED(s), to better define the safety profile and evaluate the efficacy of YL201.
CONDITIONS
Official Title
A Study of YL201 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before trial start
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ and bone marrow function
- Women of childbearing potential agree to use effective contraception during and for at least 5 months after last dose of atezolizumab or 6 months after last dose of YL201
- Men agree to use effective contraception during and for at least 6 months after last dose of YL201
- Life expectancy of at least 3 months
- Willing and able to comply with study visits and procedures
- At least one evaluable tumor lesion per RECIST version 1.1
- Pathologically confirmed advanced solid tumor (SCLC, mCRPC, ESCC, NSCLC preferred) unresponsive or intolerant to standard treatment, or no standard treatment available
- For ES-SCLC patients in Arm C: no prior anti-cancer treatment
You will not qualify if you...
- Concurrent participation in another interventional clinical study (except observational or follow-up period of interventional study)
- Prior systemic anticancer treatment within 3 weeks before first study drug dose (with specific timing exceptions for certain drugs)
- Prior radiation therapy within 4 weeks before first study drug dose (2 weeks if non-abdominal palliative stereotactic radiation)
- Major surgery within 4 weeks before first dose or expected during study
- Allogeneic hematopoietic stem cell transplant before first dose or autologous transplant within 3 months before first dose
- Systemic steroids (>10 mg/day prednisone or equivalent) or immunosuppressive therapy within 2 weeks before first dose
- Live vaccine within 4 weeks before first dose or planned during study
- Known HIV infection
- Active hepatitis B or C infection as defined by study site criteria
- Unresolved toxicities from previous anticancer therapy above specified levels
- History of severe hypersensitivity to study drug substances or related products
- Women who are pregnant or breastfeeding confirmed by pregnancy test within 7 days before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 45 locations
1
002
Fair Oaks, California, United States, 95628
Actively Recruiting
2
001
La Jolla, California, United States, 92093-0698
Actively Recruiting
3
003
Lone Tree, Colorado, United States, 80124
Actively Recruiting
4
004
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
5
005
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
006
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
007
Detroit, Michigan, United States, 48292
Actively Recruiting
8
008
St Louis, Missouri, United States, 63110
Actively Recruiting
9
009
Santa Fe, New Mexico, United States, 87505-699
Actively Recruiting
10
010
New York, New York, United States, 10029
Actively Recruiting
11
011
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
12
012
Nashville, Tennessee, United States, 37203
Actively Recruiting
13
014
Houston, Texas, United States, 77030
Actively Recruiting
14
015
Irving, Texas, United States, 75039
Actively Recruiting
15
013
San Antonio, Texas, United States, 78229
Actively Recruiting
16
016
Tyler, Texas, United States, 75701
Actively Recruiting
17
017
Fairfax, Virginia, United States, 22031
Actively Recruiting
18
018
Spokane, Washington, United States, 99208
Actively Recruiting
19
019
Tacoma, Washington, United States, 98405
Actively Recruiting
20
020
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
21
021
Kelowna, British Columbia, Canada, V1Y 1E2
Actively Recruiting
22
022
Brampton, Ontario, Canada, L6R 3J7
Actively Recruiting
23
023
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
24
024
Guangzhou, Guangdong, China, 510000
Completed
25
025
Zhengzhou, Henan, China, 450003
Completed
26
026
Bordeaux, France, 33000
Actively Recruiting
27
027
Dijon, France, 21000
Actively Recruiting
28
028
Marseille, France, 13005
Actively Recruiting
29
029
Nantes, France, 44093
Not Yet Recruiting
30
030
Paris, France, 75248
Not Yet Recruiting
31
031
Poitiers, France, 86021
Actively Recruiting
32
032
Saint-Herblain, France, 44800
Not Yet Recruiting
33
033
Suresnes, France, 92150
Actively Recruiting
34
044
Otwock, Poland, 05-400
Actively Recruiting
35
045
Poznan, Poland, 60-569
Not Yet Recruiting
36
034
Barcelona, Barcelona, Spain, 08023
Actively Recruiting
37
035
Barcelona, Barcelona, Spain, 08025
Actively Recruiting
38
039
Leganés, Madrid, Spain, 28911
Not Yet Recruiting
39
037
Madrid, Madrid, Spain, 28034
Actively Recruiting
40
036
Madrid, Madrid, Spain, 28050
Actively Recruiting
41
038
Moncloa-Aravaca, Madrid, Spain, 28040
Actively Recruiting
42
041
Pozuelo de Alarcón, Madrid, Spain, 28223
Actively Recruiting
43
042
Usera, Madrid, Spain, 28041
Actively Recruiting
44
040
Pamplona, Navarre, Spain, 31008
Actively Recruiting
45
043
Valencia, Valencia, Spain, 46010
Actively Recruiting
Research Team
S
Sasha Stann
CONTACT
A
Alan Xu, Ph.D.
CONTACT
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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