Safety and Efficacy of XmAb18087 Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Mar 13, 2024
  • participants needed
    142
  • sponsor
    Xencor, Inc.
Updated on 13 August 2021
cancer
carcinoma
lung cancer
pembrolizumab
atezolizumab
bispecific antibody

Summary

This is a Phase 1b/2, multiple-dose study designed to describe safety and efficacy, and to assess PK and immunogenicity of XmAb18087 monotherapy and in combination with pembrolizumab in subjects with metastatic Merkel cell (MCC) or locoregional MCC that has recurred after locoregional therapy with surgery and/or radiation therapy, and XmAb18087 monotherapy in subjects with extensive-stage small cell lung cancer (SCLC) that has progressed after standard therapies.

Details
Condition Neuroendocrine carcinoma, Small Cell Lung Cancer, Merkel cell carcinoma, sclc, small cell carcinoma, small cell carcinoma of the lung
Treatment XmAb18087, XmAb18087 ± Pembrolizumab
Clinical Study IdentifierNCT04590781
SponsorXencor, Inc.
Last Modified on13 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to provide written informed consent
Adult subjects 18 years
Disease measurable by RECIST 1.1 criteria using either computed tomography (CT) or magnetic resonance imaging (MRI) scan
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
All subjects must have adequate archival tumor sample (slides or archival formalin-fixed paraffin-embedded [FFPE] block[s] containing tumor that has not been previously irradiated
Female subjects of childbearing potential must agree to use a highly effective method of birth control during and for 4 weeks after completion of study. success), or sexual abstinence
Fertile male subjects must be willing to practice a highly effective method of birth control for the duration of the study and continuing for 4 weeks after the last dose of XmAb18087 or pembrolizumab (when applicable
Able and willing to complete the entire study according to the study schedule
Additional Inclusion Criteria for Part A and Part B Cohorts
Histologically or cytologically confirmed metastatic MCC or locoregional MCC
that has recurred following standard locoregional therapy with surgery and/or
radiation therapy
Additional Inclusion Criteria for Part A Cohorts
Subjects must have progressed on or been ineligible for treatment with anti-
PD1 or anti-PDL1 therapy
Additional Inclusion Criteria for Part B Cohorts
Subjects must be eligible to receive pembrolizumab as standard of care
Additional Inclusion Criteria for Part C Cohorts
Histologically or cytologically confirmed extensive-stage SCLC that has
progressed following standard therapies
\-

Exclusion Criteria

Additional Exclusion Criteria for Part B Cohorts: XmAb18087 in Combination
with Pembrolizumab In addition to the exclusion criteria in Section 8.6
subjects will be excluded from Part B safety run-in and expansion cohorts
administered XmAb18087 in combination with pembrolizumab if they meet the
following criteria
Prior treatment with therapeutics directed at anti-programmed cell death 1 (anti-PD1) or anti-programmed cell death ligand 1 (anti-PDL1)
Have severe hypersensitivity ( Grade 3) to pembrolizumab and/or any of its excipients
Clear my responses

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