Clinical Trial 23743

• Overview

  Study 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)

  Summary:

  This study is being done to find out more about tarlatamab when given in combination with AB248 in people with extensive stage small cell lung cancer (ES-SCLC), a disease in which cancer cells form in the tissues of the lung and spread to other parts of the body such as the opposite lung, bone, brain, or bone marrow

  Objective:

  Primary *For Parts 1, 2, and 3: Evaluate the safety and tolerability of tarlatamab in combination with AB248 *For Parts 1 and 2 only: Determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab Secondary *Characterize the pharmacokinetics (PK) of tarlatamab in combination with AB248 *Evaluate preliminary anti-tumor activity of tarlatamab in combination with AB248 *Evaluate the immunogenicity of AB248 in combination with tarlatamab

• Treatments

  Therapies:

  Fusion protein of an attenuated IL-2 mutein linked to an antibody; Half-Life Extended Bispecific T-cell Engager (HLE BiTE)

  Medications:

  AB248 (); Tarlatamab (AMG 757)

• Inclusion Criteria

  Inclusion Criteria:
  • Participant has provided informed consent before initiation of any study-specific activities/procedures.
  • Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
  • Participants with histologically or cytologically confirmed ES-SCLC that has progressed or recurred following at least 1 line of anti-cancer therapy for ES-SCLC.
  • Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.
  • Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver).
  • Participants 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.
  • Other criteria may apply

• Exclusion Criteria

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

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