RecruitingPhase 1Phase 2NCT07407933

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


Sponsor

MediLink Therapeutics (Suzhou) Co., Ltd.

Enrollment

118 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria5

  • 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)

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Interventions

DRUGYL201

YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.

DRUGAtezolizumab

Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle


Locations(22)

Site 1001

Washington D.C., District of Columbia, United States

Site 1004

Louisville, Kentucky, United States

Site 1005

Houston, Texas, United States

Site 1002

Fairfax, Virginia, United States

Site 1201

Namur, Belgium

Site 1703

Meldola, Italy

Site 1702

Ravenna, Italy

Site 1802

Otwock, Poland

Site 1804

Poznan, Poland

Site 1801

Przemyśl, Poland

Site 1901

Craiova, Romania

Site 2013

Badajoz, Spain

Site 2014

Barcelona, Spain

Site 2003

Barcelona, Spain

Site 2002

Madrid, Spain

Site 2005

Madrid, Spain

Site 2004

Madrid, Spain

Site 2011

Madrid, Spain

Site 2010

Manresa, Spain

Site 2009

Valencia, Spain

Site 2015

Valencia, Spain

Site 2201

London, United Kingdom

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NCT07407933