A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With YL201 With or Without Anti-PD-L1 in Subjects With Extensive Stage Small Cell Lung Cancer
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent.
• Participants with histologically or cytologically confirmed ES-SCLC.
• For Parts 1 and 2, participant must have ES-SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
• For Part 3, participants must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, etoposide, and PD-(L)1 inhibitor in the first-line setting.
• At least 1 measurable lesion as defined by RECIST 1.1.
• Participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver).
Locations
United States
California
City of Hope Orange County Lennar Foundation Cancer Center
RECRUITING
Irvine
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Missouri
Siteman Cancer Center
RECRUITING
St Louis
North Dakota
Sanford Roger Maris Cancer Center
RECRUITING
Fargo
South Dakota
Sanford Oncology Clinic and Pharmacy
RECRUITING
Sioux Falls
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Washington
Swedish Medical Center
RECRUITING
Seattle
Other Locations
China
West China Hospital of Sichuan University
RECRUITING
Chengdu
Fujian Cancer Hospital
RECRUITING
Fuzhou
Shandong Cancer Hospital
RECRUITING
Jinan
Republic of Korea
Asan Medical Center
RECRUITING
Seoul
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date:2025-05-16
Estimated Completion Date:2031-05-21
Participants
Target number of participants:200
Treatments
Experimental: Dose Exploration (Part 1)
Multiple dose levels of YL201 will be explored in combination with tarlatamab administered intravenously (IV) at a fixed dose using one-step dosing.
Experimental: Dose Expansion (Part 2)
YL201 will be administered at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV at a fixed dose.
Experimental: Triplet Combination (Part 3)
YL201 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (atezolizumab or durvalumab) administered IV at a fixed dose.