Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)

Part of paid clinical trials in Irvine, California.

Sponsor
Amgen
Study ID
NCT06898957
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • YL201 — DRUG
    YL201 will be administered as an IV infusion.
  • Tarlatamab — DRUG
    Tarlatamab will be administered as an IV infusion.
  • Durvalumab — DRUG
    Durvalumab will be administered as an IV infusion.

Study Details

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.

Key Dates

Start date
May 16, 2025
Status verified
May 2026
Primary completion
Jun 23, 2031
Completion
Jun 23, 2031

Study Design

Enrollment
29 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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 (durvalumab) administered IV at a fixed dose.

Primary Outcome Measure

Number of Participants Experiencing Dose-limiting toxicities (DLTs) [ Time Frame: Up to Day 21 ]

Locations (11)

FacilityCityStateZIPSite coordinators
City of Hope Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618-
Yale New Haven HospitalNew HavenConnecticut06510-
Moffitt Cancer CenterTampaFlorida33612-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Siteman Cancer CenterSt LouisMissouri63110-
Sanford Roger Maris Cancer CenterFargoNorth Dakota58122-
Cleveland Clinic FoundationClevelandOhio44195-
Sanford Oncology Clinic and PharmacySioux FallsSouth Dakota54104-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Fred Hutchinson Cancer CenterSeattleWashington98109-
Swedish Medical CenterSeattleWashington98104-

Find similar trials in Irvine, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
City of Hope Orange County Lennar Foundation Cancer Center· Irvine, CAYale New Haven Hospital· New Haven, CTMoffitt Cancer Center· Tampa, FLDana Farber Cancer Institute· Boston, MASiteman Cancer Center· St Louis, MOSanford Roger Maris Cancer Center· Fargo, ND

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