RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. • ClinicalTrials.gov ID: NCT07407933

Registry updated: 2026-09-17

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Description

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.

Interventions

YL201 (Drug)
YL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.
Atezolizumab (Drug)
Atezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle

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.

Conditions

Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma

Locations

Site 1001 — Washington D.C., District of Columbia, United States
Site 1009 — Plantation, Florida, United States
Site 1004 — Louisville, Kentucky, United States
Site 1005 — Houston, Texas, United States
Site 1002 — Fairfax, Virginia, United States
Site 1203 — Edegem, Belgium
Site 1201 — Namur, Belgium
Site 1402 — Nice, France
Site 1404 — Paris, France
Site 1403 — Suresnes, France
Site 1601 — Kalocsa, Hungary
Site 1705 — Candiolo, Italy
Site 1703 — Meldola, Italy
Site 1702 — Ravenna, Italy
Site 1802 — Otwock, Poland
Site 1804 — Poznan, Poland
Site 1801 — Przemyśl, Poland
Site 1904 — Bucharest, Romania
Site 1903 — Cluj-Napoca, Romania
Site 1901 — Craiova, Romania
Site 2013 — Badajoz, Spain
Site 2012 — Badalona, Spain
Site 2014 — Barcelona, Spain
Site 2003 — Barcelona, Spain
Site 2006 — Barcelona, Spain
Site 2001 — Barcelona, Spain
Site 2007 — Girona, Spain
Site 2002 — Madrid, Spain
Site 2005 — Madrid, Spain
Site 2019 — Madrid, Spain
Site 2004 — Madrid, Spain
Site 2011 — Madrid, Spain
Site 2010 — Manresa, Spain
Site 2008 — Seville, Spain
Site 2009 — Valencia, Spain
Site 2015 — Valencia, Spain
Site 2203 — Edinburgh, United Kingdom
Site 2201 — London, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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