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

  • Interventional
  • Recruiting
  • NCT03319940
Eligibility Details Visit Clinicaltrials.gov

A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)

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

This is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab monotherapy, in combination with anti-PD1 therapy and with additional cytokine release syndrome (CRS) mitigation strategies. Tarlatamab will be administered as a short term intravenous (IV) infusion in participants with SCLC. Tarlatamab is a Half-Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Participant has provided informed consent prior to initiation of any study-specific activities/procedures

         - Age greater than or equal to 18 years old at the time of signing the informed consent

         - Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen

         - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

         - Participants with treated brain metastases are eligible provided they meet defined criteria

         - Adequate organ function as defined in protocol

        Exclusion Criteria:

         - History of other malignancy within the past 2 years prior to first dose of tarlatamab with exceptions

         - Major surgery within 28 days of first dose tarlatamab

         - Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not).

         - Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab

         - Participants who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated AEs or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents

         - Has evidence of interstitial lung disease or active, non-infectious pneumonitis

         - Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab

         - Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years

         - Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration

At a Glance

National Government IDNCT03319940

IRB#IRB18-1263

Lead SponsorAmgen

Lead PhysicianEverett E. Vokes

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting