Informations générales (source: ClinicalTrials.gov)
A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)
Interventional
Phase 1
Amgen (Voir sur ClinicalTrials)
décembre 2017
octobre 2026
04 juillet 2025
A study to assess the safety, tolerability, and PK of tarlatamab in participants with
SCLC
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | St�phane CHAMPIAT | 29/05/2024 08:08:26 | Contacter | ||
Critères
Tous
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
- 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
- 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