Actively Recruiting
A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2026-04-09
118
Participants Needed
4
Research Sites
148 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 phase Ib/II, multicenter, open-label study of YL201 combined with atezolizumab. The study will include 2 parts. Part 1 of the study is a dose escalation in participants with previously untreated ES-SCLC to determine the safety and tolerability of YL201 in combination with fixed dose of atezolizumab. The planned dose levels of YL201 are 1.2 mg/kg, 1.6 mg/kg and 2.0 mg/kg. Part 2 consists of a dose optimization stage followed by a dose expansion stage. During the dose optimization stage, participants will be randomized 1:1:1 to receive either YL201 at 1.2 mg/kg,1.6 mg/kg or 2.0 mg/kg Q3W in combination with fixed dose of atezolizumab. The decision to initiate the dose expansion stage in Part 2 and choose one or two of the YL201 dose level(s) will be based on the review of safety, PK, and efficacy from the dose optimization stage. Treatment will continue until disease progression, unacceptable toxicity, or withdraw of consent.
CONDITIONS
Official Title
A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically or cytologically confirmed diagnosis of ES-SCLC
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate hematologic and end-organ function
You will not qualify if you...
- Prior systemic anti-cancer treatment for ES-SCLC
- Prior treatment targeting B7H3 or topoisomerase I inhibitor
- Clinically active brain metastases or spinal cord compression
- Current or history of interstitial lung disease or pneumonitis
- Clinically significant cardiovascular disease such as New York Heart Association class II to IV congestive heart failure
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Site 1001
Washington D.C., District of Columbia, United States, 20057
Not Yet Recruiting
2
Site 1005
Houston, Texas, United States, 77030
Actively Recruiting
3
Site 1002
Fairfax, Virginia, United States, 22031
Actively Recruiting
4
Site 2201
London, United Kingdom, W12 0HS
Actively Recruiting
Research Team
M
MediLink Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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