A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)
Overview
- Phase
- Phase 1
- Intervention
- Tarlatamab
- Conditions
- Not specified
- Sponsor
- Amgen Inc.
- Enrollment
- 110
- Locations
- 39
- Primary Endpoint
- Number of participants with dose limiting toxicities (DLT) for all indications
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC
Detailed Description
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)
Investigators
Medical Information
Scientific
Amgen Inc.
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part A
Tarlatamab monotherapy
Intervention: Tarlatamab
Part C
Tarlatamab with Pembrolizumab
Intervention: Tarlatamab
Part C
Tarlatamab with Pembrolizumab
Intervention: Pembrolizumab
Part D
Tarlatamab with additional CRS mitigation strategies
Intervention: Tarlatamab
Part D
Tarlatamab with additional CRS mitigation strategies
Intervention: CRS Mitigation Strategies
Part E
Tarlatamab administration with 24-hour monitoring
Intervention: Tarlatamab
Part F
Tarlatamab administered in outpatient infusion centers with 8-hour monitoring Optional wearable digital device substudy (US sites only)
Intervention: Tarlatamab
Part G
Tarlatamab additional dosing schedule Optional wearable digital device substudy (US sites only)
Intervention: Tarlatamab
Outcomes
Primary Outcomes
Number of participants with dose limiting toxicities (DLT) for all indications
Time Frame: 6 months
Number of participants with treatment-emergent adverse events (AEs) for all indications
Time Frame: 4 years
Number of participants with treatment-related AEs for all indications
Time Frame: 4 years
Number of participants with clinically significant changes in vital signs for all indications
Time Frame: 4 years
Number of participants with significant changes in electrocardiogram (ECG) for all indications
Time Frame: 4 years
Number of participants with significant changes in physical examinations for all indications
Time Frame: 4 years
Number of participants with significant changes in clinical laboratory tests for all indications
Time Frame: 4 years
Secondary Outcomes
- Maximum observed concentration (Cmax) following intravenous administration for all indications(4 years)
- Minimum observed concentration (Cmin) following intravenous administration for all indications(4 years)
- Area under the concentration-time curve (AUC) over the 2 week dosing interval for all indications(4 years)
- Accumulation following multiple dosing for all indications(4 years)
- Half-life (t1/2) following intravenous administration for all indications(4 years)
- Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1(4 years)
- Duration of Response (DOR) for all indications(4 years)
- Time to Response (TTR)(4 years)
- 9-month Progression-Free Survival (PFS) for all indications(9 months)
- 9-month Overall Survival (OS) for all indications(9 months)