Small Cell Lung Cancer (SCLC) Clinical Trials

Find Small Cell Lung Cancer (SCLC) Clinical Trials Near You

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

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington, D.c.
Site 1001
NOT_YET_RECRUITING
Washington D.c.
Kentucky
Site 1004
RECRUITING
Louisville
Texas
Site 1005
RECRUITING
Houston
Virginia
Site 1002
RECRUITING
Fairfax
Other Locations
Belgium
Site 1201
RECRUITING
Namur
Italy
Site 1703
RECRUITING
Meldola
Site 1702
RECRUITING
Ravenna
Poland
Site 1802
RECRUITING
Otwock
Site 1804
RECRUITING
Poznan
Site 1801
RECRUITING
Przemyśl
Romania
Site 1901
RECRUITING
Craiova
Spain
Site 2013
RECRUITING
Badajoz
Site 2003
RECRUITING
Barcelona
Site 2014
RECRUITING
Barcelona
Site 2002
RECRUITING
Madrid
Site 2004
RECRUITING
Madrid
Site 2005
RECRUITING
Madrid
Site 2011
RECRUITING
Madrid
Site 2010
RECRUITING
Manresa
Site 2009
RECRUITING
Valencia
Site 2015
RECRUITING
Valencia
United Kingdom
Site 2201
RECRUITING
London
Contact Information
Primary
MediLink Study Team
clinicaltrials@medilinkthera.com
86 0512-62858368
Time Frame
Start Date: 2026-03-31
Estimated Completion Date: 2029-02
Participants
Target number of participants: 118
Treatments
Experimental: YL201 1.2mg/kg in combination with atezolizumab 1200mg Q3W
Experimental: YL201 1.6mg/kg in combination with atezolizumab 1200mg Q3W
Experimental: YL201 2.0mg/kg in combination with atezolizumab 1200mg Q3W
Sponsors
Collaborators: Genentech, Inc., Hoffmann-La Roche
Leads: MediLink Therapeutics (Suzhou) Co., Ltd.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials