Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Part of paid clinical trials in Duarte, California.

Sponsor
Amgen
Study ID
NCT03319940
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tarlatamab — DRUG
    Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
  • Pembrolizumab — DRUG
    Pembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2
  • CRS Mitigation Strategies — DRUG
    Participants will be treated with one of the CRS mitigation strategies.

Study Details

A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

Key Dates

Start date
Dec 26, 2017
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
269 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A
    Tarlatamab monotherapy
  • Experimental: Part C
    Tarlatamab with Pembrolizumab
  • Experimental: Part D
    Tarlatamab with additional CRS mitigation strategies
  • Experimental: Part E
    Tarlatamab administration with 24-hour monitoring
  • Experimental: Part F
    Tarlatamab administered in outpatient infusion centers with 8-hour monitoring Optional wearable digital device substudy (US sites only)
  • Experimental: Part G
    Tarlatamab additional dosing schedule Optional wearable digital device substudy (US sites only)

Primary Outcome Measure

Number of participants with dose limiting toxicities (DLT) for all indications [ Time Frame: 6 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
Yale New Haven HospitalNew HavenConnecticut06510-
Moffitt Cancer CenterTampaFlorida33612-
Winship Cancer InstituteAtlantaGeorgia30322-
University of ChicagoChicagoIllinois60637-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
John Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287-
Henry Ford Health SystemDetroitMichigan48202-
Washington UniversitySt LouisMissouri63110-1093-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
The Ohio State University Wexner Medical Center - Thoracic Oncology ClinicColumbusOhio43210-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
University of Pittsburgh Medical Center Cancer PavillionPittsburghPennsylvania15232-
Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAYale New Haven Hospital· New Haven, CTMoffitt Cancer Center· Tampa, FLWinship Cancer Institute· Atlanta, GAUniversity of Chicago· Chicago, ILOchsner Clinic Foundation· New Orleans, LA

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