Actively Recruiting
A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2026-01-02
155
Participants Needed
21
Research Sites
257 weeks
Total Duration
On this page
Sponsors
M
MediLink Therapeutics (Suzhou) Co., Ltd.
Lead Sponsor
H
Hoffmann-La Roche
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of three parts. Part 1 is dose-escalation part. In part 1, the safety and tolerability of YL211 in patients with selected advanced solid tumors will be evaluated and the MTD and RED will be determined. Part 2 is backfill enrollment part. We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the RED(s) of YL211. Part 3 is dose-expansion part. In this part, we will further evaluate the safety and efficacy of YL211 at the MTD/RED(s) in patients with selected advanced solid tumors YL211 will be administered intravenously (IV) until criteria of treatment discontinuation are met.
CONDITIONS
Official Title
A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signed informed consent before starting the trial
- Age 18 years or older
- Able and willing to comply with study visits and procedures
- History of advanced solid tumors unresponsive to standard therapies or no available approved therapies
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Adequate organ and bone marrow function
- At least 1 measurable extracranial tumor lesion by RECIST version 1.1
You will not qualify if you...
- Inadequate washout period from prior anticancer treatments before first study drug dose
- Uncontrolled or significant cardiovascular or cerebrovascular diseases
- Clinically significant lung disease
- Uncontrolled infection requiring systemic therapy within 2 weeks before first dose
- Unresolved toxicities from previous anticancer therapy
- History of severe allergic reactions to the study drug, its ingredients, or other monoclonal antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Not Yet Recruiting
2
Sarah Cannon Research Institute (SCRI) at HealthONE
Denver, Colorado, United States, 80218-1238
Actively Recruiting
3
Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven
North Haven, Connecticut, United States, 06473-2142
Actively Recruiting
4
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, United States, 32827
Actively Recruiting
5
Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office
Sarasota, Florida, United States, 34232-6422
Actively Recruiting
6
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, United States, 89169
Active, Not Recruiting
7
University of Cincinnati Vontz Center for Molecular Studies
Cincinnati, Ohio, United States, 45219
Actively Recruiting
8
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
9
NEXT Oncology - Houston
Houston, Texas, United States, 77055
Actively Recruiting
10
NEXT Oncology - Dallas
Irving, Texas, United States, 75039
Actively Recruiting
11
NEXT San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
12
Gosford Hospital
Gosford, New South Wales, Australia, 2250
Active, Not Recruiting
13
One Clinical Research - Nedlands
Nedlands, Western Australia, Australia, 6009
Not Yet Recruiting
14
Monash Health
Melbourne, Australia
Actively Recruiting
15
Princess Margaret Hospital
Toronto, Toronto, Canada
Actively Recruiting
16
The Ottawa Hospital - General Campus
Ottawa, Canada
Not Yet Recruiting
17
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
18
The First Affiliated Hospital - Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
19
Wenzhou Medical University - The First Affiliated Hospital
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
20
West China Hospital, Sichuan University
Chengdu, China
Not Yet Recruiting
21
Sun Yat-sen University Cancer Center
Guangzhou, China
Actively Recruiting
Research Team
M
MediLink Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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