YL201 combined with atezolizumab for small cell lung cancer that has spread
Tests YL201 with atezolizumab in adults with previously untreated extensive-stage small cell lung cancer.
Plain-language title generated from the registry record
Registry title: A Study of YL201 in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors
Key facts
- Where
- Bucharest, Cluj-Napoca, and Craiova, RomaniaSee the 3 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Source: NCT07407933, who can take part
Where in Romania
- BucharestBucharest, RomaniaTaking people
- Cluj-NapocaCluj-Napoca, RomaniaTaking people
- CraiovaCraiova, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- MediLink Therapeutics (Suzhou) Co., Ltd.
- Trial code
- NCT07407933
- Record updated
- 17 September 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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: No prior systemic anti-cancer treatment for ES-SCLC; No prior treatment targeting B7H3 or topoisomerase I inhibitor; 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; No clinically active brain metastases or spinal cord compression.