YL201 plus atezolizumab for newly diagnosed extensive-stage small cell lung cancer
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 trial will try YL201 together with atezolizumab to see if the combo is safe and helpful for people with newly diagnosed extensive-stage small cell lung cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MediLink Therapeutics (Suzhou) Co., Ltd. Industry-sponsored |
| Drugs / interventions | atezolizumab |
| Locations | 4 sites (Washington D.C., District of Columbia and 3 other locations) |
| Trial ID | NCT07407933 on ClinicalTrials.gov |
What this trial studies
This phase Ib/II, multicenter, open-label study combines the antibody–drug conjugate YL201 with the PD-L1 inhibitor atezolizumab in patients with newly diagnosed extensive-stage small cell lung cancer (ES-SCLC). Part 1 is a dose-escalation cohort testing planned YL201 doses of 1.2, 1.6, and 2.0 mg/kg given every three weeks alongside a fixed dose of atezolizumab to characterize safety and tolerability. Part 2 begins with a randomized dose-optimization stage (1:1:1 to the three doses) and then moves to a dose-expansion stage where one or two doses will be selected based on safety, pharmacokinetics, and early efficacy signals. Treatment continues until disease progression, unacceptable toxicity, or withdrawal of consent, with collection of safety, PK, and tumor response data.
Who should consider this trial
Good fit: Adults (age 18 or older) with histologically or cytologically confirmed extensive-stage SCLC, ECOG performance status 0–1, adequate organ function, and no prior systemic treatment for ES-SCLC are ideal candidates.
Not a fit: Patients who have had prior systemic therapy for ES-SCLC, prior B7-H3 or topoisomerase I–targeting treatments, active brain metastases, a history of ILD/pneumonitis, or significant cardiac disease are unlikely to qualify or receive benefit from this study.
Why it matters
Potential benefit: If successful, the combination could provide a more effective treatment option and longer disease control for people with extensive-stage small cell lung cancer.
How similar studies have performed: Atezolizumab has shown benefit when added to chemotherapy in ES-SCLC, but combining it with a B7-H3–targeting ADC like YL201 is a novel approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Washington D.C., District of Columbia and 3 other locations
- Site 1001 — Washington D.C., District of Columbia, United States (Not_yet_recruiting)
- Site 1005 — Houston, Texas, United States (Recruiting)
- Site 1002 — Fairfax, Virginia, United States (Recruiting)
- Site 2201 — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: MediLink Study Team
- Email: clinicaltrials@medilinkthera.com
- Phone: 86 0512-62858368
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.