RecruitingRecruiting
A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
NCT07407933 · MediLink Therapeutics (Suzhou) Co., Ltd.
In plain English
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Official title
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
About this study
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 criteria
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-SCLC
2. No prior treatment targeting B7H3 or topoisomerase I inhibitor
3. No clinically active brain metastases or spinal cord compression
4. No current or history of interstitial lung disease (ILD)/ pneumonitis
5. No clinically significant cardiovascular disease (eg, New York Heart Association class II to IV congestive heart failure)
Other protocol-defined inclusion/ exclusion criteria may apply.
Study design
Enrollment target: 118 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-03-31
Estimated completion: 2029-02
Last updated: 2026-09-17
Interventions
Drug: YL201Drug: Atezolizumab
Primary outcomes
- • 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))
Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd. · industry
With: Hoffmann-La Roche, Genentech, Inc.
Contacts & investigators
ContactMediLink Study Team · contact · clinicaltrials@medilinkthera.com · 86 0512-62858368
All locations (38)
Site 1001Recruiting
Washington D.C., District of Columbia, United States
Site 1009Recruiting
Plantation, Florida, United States
Site 1004Recruiting
Louisville, Kentucky, United States
Site 1005Recruiting
Houston, Texas, United States
Site 1002Recruiting
Fairfax, Virginia, United States
Site 1203Recruiting
Edegem, Belgium
Site 1201Recruiting
Namur, Belgium
Site 1402Recruiting
Nice, France
Site 1404Recruiting
Paris, France
Site 1403Recruiting
Suresnes, France
Site 1601Recruiting
Kalocsa, Hungary
Site 1705Recruiting
Candiolo, Italy
Site 1703Recruiting
Meldola, Italy
Site 1702Recruiting
Ravenna, Italy
Site 1802Recruiting
Otwock, Poland
Site 1804Recruiting
Poznan, Poland
Site 1801Recruiting
Przemyśl, Poland
Site 1904Recruiting
Bucharest, Romania
Site 1903Recruiting
Cluj-Napoca, Romania
Site 1901Recruiting
Craiova, Romania
Site 2013Recruiting
Badajoz, Spain
Site 2012Recruiting
Badalona, Spain
Site 2014Recruiting
Barcelona, Spain
Site 2003Recruiting
Barcelona, Spain
Site 2006Recruiting
Barcelona, Spain
Site 2001Recruiting
Barcelona, Spain
Site 2007Recruiting
Girona, Spain
Site 2002Recruiting
Madrid, Spain
Site 2005Recruiting
Madrid, Spain
Site 2019Recruiting
Madrid, Spain
Site 2004Recruiting
Madrid, Spain
Site 2011Recruiting
Madrid, Spain
Site 2010Recruiting
Manresa, Spain
Site 2008Recruiting
Seville, Spain
Site 2009Recruiting
Valencia, Spain
Site 2015Recruiting
Valencia, Spain
Site 2203Recruiting
Edinburgh, United Kingdom
Site 2201Recruiting
London, United Kingdom