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Official Title

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Phase
Phase 1
Sponsor
Amgen
Enrollment
380
Timeline
Sep 2025 → Jan 2031
About This Study

The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248. The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.

Eligibility Criteria

Inclusion Criteria

  • 1Participant has provided informed consent before initiation of any study-specific activities/procedures.
  • 2Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
  • 3Participants with histologically or cytologically confirmed ES-SCLC that has progressed or recurred following at least 1 line of anti-cancer therapy for ES-SCLC.
  • 4Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.
  • 5Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver).
  • 6Participants must submit a fresh tumor biopsy at screening unless a new biopsy cannot be performed safely or is infeasible. Participants who cannot provide fresh tissue may provide archival tissue that was collected after last anticancer therapy.

Exclusion Criteria

  • 1Symptomatic central nervous system (CNS) metastases.
  • 2Participants with brain metastases may be eligible if criteria defined in the protocol are met.
  • 3Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab).
  • 4Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy.
  • 5Baseline (at rest) requirement of supplemental oxygen.

Locations

10 sites participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting

Norton Cancer Institute - Downtown

Louisville, Kentucky 40202-1703

Recruiting

Siteman Cancer Center

St Louis, Missouri 63110

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →