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.
None
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
Single group
YL201
DrugYL201 intravenous infusion will be administered on Day 1 of each 21-day cycle.
Atezolizumab
DrugAtezolizumab intravenous infusion will be administered at a dose of 1200 mg on Day 1 of each 21-day cycle
Nature and Frequency with Dose-Limiting Toxicities (DLTs)
Adverse Events
Incidence, nature, and severity of AEs graded according to the NCI CTCAE v5
ORR
DOR
PFS
OS
Click on the lead sponsor to view all of their trials.
MediLink Therapeutics (Suzhou) Co., Ltd.
Lead sponsor
Hoffmann-La Roche
Collaborator
Genentech, Inc.
Collaborator
