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

Recruiting now · Phase 1/Phase 2

Conditions studied: Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma

In brief

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.

Key facts

Study ID

NCT07407933

Run by

MediLink Therapeutics (Suzhou) Co., Ltd.

People needed

118

Starts

2026-03-31

Expected to finish

2029-02-01

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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)
• Other protocol-defined inclusion/ exclusion criteria may apply.

Where it is running

• Site 2201 — London, United Kingdom (enrolling)
• Site 1004 — Louisville, Kentucky, United States (enrolling)
• Site 1005 — Houston, Texas, United States (enrolling)
• Site 1002 — Fairfax, Virginia, United States (enrolling)
• Site 1201 — Namur, Belgium (enrolling)
• Site 1703 — Meldola, Italy (enrolling)
• Site 1702 — Ravenna, Italy (enrolling)
• Site 1802 — Otwock, Poland (enrolling)
• Site 1804 — Poznan, Poland (enrolling)
• Site 1801 — Przemyśl, Poland (enrolling)
• Site 1901 — Craiova, Romania (enrolling)
• Site 2013 — Badajoz, Spain (enrolling)
• Site 2014 — Barcelona, Spain (enrolling)
• Site 2003 — Barcelona, Spain (enrolling)
• Site 2002 — Madrid, Spain (enrolling)
• Site 2005 — Madrid, Spain (enrolling)
• Site 2004 — Madrid, Spain (enrolling)
• Site 2011 — Madrid, Spain (enrolling)
• Site 2010 — Manresa, Spain (enrolling)
• Site 2009 — Valencia, Spain (enrolling)
• Site 2015 — Valencia, Spain (enrolling)
• Site 1001 — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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