Clinical Trial 23645

• Overview

  Study Title:

  A Phase 1 Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors

  Summary:

  This is a phase 1, first-in-human, open-label, dose-escalation study of XB628, a first-in-class bispecific antibody natural killer (NK) cell engager that targets NK group 2 member A (NKG2A), an inhibitory receptor on NK cells, and programmed cell death-ligand 1 (PD-L1).

  Objective:

  Primary objective: * To evaluate the safety and tolerability of XB628 Secondary Objectives: * To characterize the PK of XB628 * To assess the immunogenicity of XB628 * To assess the preliminary antitumor activity of XB628 * To determine the recommended dose/doses for XB628 expansion development

• Treatments

  Therapies:

  Bispecific Antibody; NKG2A Inhibitor; PD-L1 Inhibitor

  Medications:

  XB628 ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Minimum life expectancy of ≥ 12 weeks.
  • Have a recurrent advanced or metastatic solid tumor that is histologically or cytologically confirmed.
  • Adequate organ and marrow function.
  • Not amenable to curative treatment with surgery or radiation.
  • Received at least 1 line of prior systemic anticancer therapy in the recurrent or metastatic setting.
  • Acceptable alternative therapy was received, refused, intolerable, or no longer effective.
  • Capable of understanding and complying with the protocol requirements and provide signed informed consent according to the protocol and local requirements.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Primary brain tumors or known active brain metastases.
  • Major surgery (eg, gastrointestinal surgery, removal or biopsy of brain metastasis) within 4 weeks before the first dose of study treatment.
  • Received radiation therapy within 1 week before the first dose of study treatment or clinically relevant ongoing complications from prior radiation therapy.
  • Received prior therapy targeting NK cells (eg, monalizumab).
  • A woman of childbearing potential has a positive serum pregnancy test within 7 days prior to study treatment.

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