Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
- Interventional
- Recruiting
- NCT03319940
Contact Information
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
- 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
- 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
- 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