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YL201

Phase 3

Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma | Small molecule | Oncology |Roche Holding AG|Last Updated: Jun 15, 2026

Development status

Highest phase Phase 3 run by MediLink Therapeutics (Suzhou) Co., Ltd. (NCT07739758)
Phase scored for RHHBYPhase 1
Registered trials 7 across 2 sponsors since Jun 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment118

FDA Designations

No designations recorded

Clinical trial landscape

YL201 · 1 trial · 1 indication

Phase 1 1
NCT07407933A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid TumorsThoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma
RECRUITING118 Analytics
PHASE1RECRUITING
A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma
NCT07407933118
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Study Endpoints

Primary Endpoints

Nature and Frequency with Dose-Limiting Toxicities (DLTs)
21 days
Adverse Events
First dose of study treatment up to disease progression or death from any cause (up to approximately 6 years)

Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5

Secondary Endpoints

ORR
Up to approximately 3 years
DOR
Up to approximately 3 years
PFS
Up to approximately 3 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3WEXPERIMENTAL -
YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3WEXPERIMENTAL -
YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3WEXPERIMENTAL -

Interventions

NameTypeDescription
YL201DRUGYL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.
AtezolizumabDRUGAtezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: 1.18 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 Exclusion Criteria: 1. No prior systemic anti-cancer treatment for ES...

Countries:United StatesBelgiumItalyPolandRomaniaSpainUnited Kingdom
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