A Clinical Study Evaluate YL201 Drug Combinations in Patients with Advanced Solid Tumors
Research type
Research Study
Full title
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
IRAS ID
1013218
Contact name
Wei Qi
Contact email
Sponsor organisation
MediLink Therapeutics (Suzhou) Co., Ltd.
Clinicaltrials.gov Identifier
Research summary
This study is testing a new drug called YL201 together with atezolizumab (or similar cancer medicines) to see if the combination is safe, works well, and how it moves through the body. It focuses on people with an aggressive type of lung cancer (extensive-stage small cell lung cancer) who haven’t had any treatment yet.
Lung cancer is one of the most common and deadly cancers worldwide, with millions of new cases and deaths each year.
Small-cell lung cancer (SCLC) makes up about 15% of lung cancers and is different from the more common non-small-cell type. Most people with SCLC are diagnosed when the disease has already spread widely. It grows and spreads quickly, resists treatment fast, and survival rates are very low—less than 20% live two years after diagnosis.
For decades, treatment hasn’t changed much, relying on chemotherapy drugs like platinum and etoposide. Recently, adding immunotherapy drugs such as atezolizumab and durvalumab has helped patients live longer.
Even with these improvements, the cancer almost always comes back, and current treatments can cause serious side effects like nerve damage, kidney problems, and low blood counts.
This study is testing a new drug, YL201, combined with atezolizumab to see if it’s safe and works better for people who haven’t had treatment yet. MediLink believe this combination could offer a better balance of benefits and risks for patients.This study has two parts:
• Part 1: Start with small groups of patients who haven’t had treatment yet. Give them increasing doses of the new drug (YL201) combined with atezolizumab to find the highest dose that is safe. If side effects are too severe, the dose won’t go higher.
• Part 2: After finding safe doses, test them in a larger group. Patients will be randomly assigned to one of three dose levels of YL201 (low, medium, or high) plus atezolizumab.REC name
South Central - Oxford B Research Ethics Committee
REC reference
26/SC/0003
Date of REC Opinion
5 Feb 2026
REC opinion
Further Information Favourable Opinion