Condition: Thoracic Neoplasms, Lung Diseases, Small Cell Lung Carcinoma · Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
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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.
This description comes directly from the study's public registry record.
MediLink Study Team · 86 0512-62858368 · clinicaltrials@medilinkthera.com
Always discuss trial participation with your own doctor first.
| Site 1001 | Washington D.C., District of Columbia, United States | Not Yet Recruiting |
| Site 1004 | Louisville, Kentucky, United States | Recruiting |
| Site 1005 | Houston, Texas, United States | Recruiting |
| Site 1002 | Fairfax, Virginia, United States | Recruiting |
| Site 1201 | Namur, Belgium | Recruiting |
| Site 1703 | Meldola, Italy | Recruiting |
| Site 1702 | Ravenna, Italy | Recruiting |
| Site 1802 | Otwock, Poland | Recruiting |
| Site 1804 | Poznan, Poland | Recruiting |
| Site 1801 | Przemyśl, Poland | Recruiting |
| Site 1901 | Craiova, Romania | Recruiting |
| Site 2013 | Badajoz, Spain | Recruiting |
+ 10 more locations — full list on the registry record.
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