Clinical Trial 23581

• Overview

  Study Title:

  A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination with YL201 with or without Anti-PD-L1 in Subjects with Extensive Stage Small Cell Lung Cancer

  Summary:

  The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.

  Objective:

  Primary: Evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1 Secondary: Evaluate preliminary anti-tumor activity of tarlatamab in combination with YL201 with or without anti-PD-L1, Characterize the pharmacokinetics (PK) of tarlatamab when combined with YL201 with or without anti-PD-L1

• Treatments

  Therapies:

  Anti-B7-H3 human monoclonal antibody conjugate; Half-Life Extended Bispecific T-cell Engager (HLE BiTE); Human IgG1 monoclonal antibody directed against PD-L1; Human monoclonal antibody of the immunoglobulin G1 kappa subclass

  Medications:

  AMP-514 (Durvalumab); Atezolizumab (Tecentriq); Durvalumab (); MEDI4736 (Durvalumab); Tarlatamab (AMG 757); YL201 ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent.
  • Participants with histologically or cytologically confirmed ES-SCLC.
  • For Parts 1 and 2, participant must have ES-SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
  • For Part 3, participants must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, etoposide, and PD-(L)1 inhibitor in the first-line setting.
  • At least 1 measurable lesion as defined by RECIST 1.1.
  • Participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver).

• Exclusion Criteria

  Key Exclusion Criteria:
  • Prior delta-like ligand 3 (DLL3) or B7 homolog 3 (B7-H3) targeted therapy.
  • Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
  • Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol.
  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
  • Baseline requirement of supplemental oxygen.

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