A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
1 other identifier
interventional
118
7 countries
22
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2026
Typical duration for phase_1
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2026
CompletedFirst Posted
Study publicly available on registry
February 12, 2026
CompletedStudy Start
First participant enrolled
March 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
June 15, 2026
June 1, 2026
2.6 years
February 6, 2026
June 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Nature and Frequency with Dose-Limiting Toxicities (DLTs)
21 days
Adverse Events
Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5
First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years)
Secondary Outcomes (9)
ORR
Up to approximately 3 years
DOR
Up to approximately 3 years
PFS
Up to approximately 3 years
OS
Up to approximately 3 years
AUC
Up to approximately 3 years
- +4 more secondary outcomes
Study Arms (3)
YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W
EXPERIMENTALYL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W
EXPERIMENTALYL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W
EXPERIMENTALInterventions
YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.
Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle
Eligibility Criteria
You may qualify if:
- years of age or older. 2. Histologically or cytologically confirmed diagnosis of ES-SCLC 3. Eastern Cooperative Oncology Group performance status of 0 or 1 4. Adequate hematologic and end-organ function
You may not qualify if:
- No prior systemic anti-cancer treatment for ES-SCLC
- No prior treatment targeting B7H3 or topoisomerase I inhibitor
- No clinically active brain metastases or spinal cord compression
- No current or history of interstitial lung disease (ILD)/ pneumonitis
- No clinically significant cardiovascular disease (eg, New York Heart Association class II to IV congestive heart failure)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MediLink Therapeutics (Suzhou) Co., Ltd.lead
- Hoffmann-La Rochecollaborator
- Genentech, Inc.collaborator
Study Sites (22)
Site 1001
Washington D.C., District of Columbia, 20057, United States
Site 1004
Louisville, Kentucky, 40202, United States
Site 1005
Houston, Texas, 77030, United States
Site 1002
Fairfax, Virginia, 22031, United States
Site 1201
Namur, 5000, Belgium
Site 1703
Meldola, 47014, Italy
Site 1702
Ravenna, 48121, Italy
Site 1802
Otwock, 05-400, Poland
Site 1804
Poznan, 60-569, Poland
Site 1801
Przemyśl, 37-700, Poland
Site 1901
Craiova, 109, Romania
Site 2013
Badajoz, 06080, Spain
Site 2014
Barcelona, 08017, Spain
Site 2003
Barcelona, 08023, Spain
Site 2002
Madrid, 28034, Spain
Site 2005
Madrid, 28040, Spain
Site 2004
Madrid, 28223, Spain
Site 2011
Madrid, 28850, Spain
Site 2010
Manresa, 08242, Spain
Site 2009
Valencia, 46010, Spain
Site 2015
Valencia, 46026, Spain
Site 2201
London, W12 0HS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2026
First Posted
February 12, 2026
Study Start
March 31, 2026
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
February 1, 2029
Last Updated
June 15, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share