Clinical Trial 24110

• Overview

  Study Title:

  A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination with ZL-1310 with or without Anti-PD-L1 in Participants with Small Cell Lung Cancer

  Summary:

  The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.

  Objective:

  Primary Objectives: *Evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab *Determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab Secondary Objectives: *Evaluate preliminary antitumor activity of tarlatamab in combination with ZL-1310 with or without durvalumab *Characterize the PK of tarlatamab in combination with ZL-1310 with or without durvalumab

• Treatments

  Therapies:

  Antibody-Drug Conjugate; Immunotherapy

  Medications:

  AMP-514 (Durvalumab); Durvalumab (); MEDI4736 (Durvalumab); Tarlatamab (AMG 757); ZL-1310 ()

• Inclusion Criteria

  Inclusion Criteria:
  • Age ≥ 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 SCLC:
  • For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
  • For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1.
  • For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • At least 1 measurable lesion as defined per RECIST v1.1 within 21-day screening period, not previously irradiated.
  • Adequate organ function (hematological, coagulation, renal, hepatic, pulmonary, and cardiac function).

• Exclusion Criteria

  Exclusion Criteria:
  • Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol.
  • History of interstitial lung disease (ILD)/pneumonitis.
  • Received thoracic radiation therapy within 90 days prior to first dose of trial intervention.
  • Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy.
  • Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
  • Receiving strong CYP3A4 or CPY2D6 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of trial treatment.
  • Enrollment in any tarlatamab clinical trial.

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