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

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ClinicalTrials.gov Identifier: NCT04590781
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : August 5, 2021
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
Xencor, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Merkel Cell Carcinoma Small Cell Lung Cancer Biological: XmAb18087 Drug: XmAb18087 ± Pembrolizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2 Multiple-Dose Study to Evaluate the Safety and Efficacy of XmAb18087 ± Pembrolizumab in Subjects With Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer (DUET-1-02) Protocol
Actual Study Start Date : May 10, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 2024


Arm Intervention/treatment
Experimental: Part A: XmAb18087 Monotherapy
Part A, will enroll subjects with previously treated advanced MCC, consists of safety-run in cohorts followed by an expansion cohort.
Biological: XmAb18087
Monoclonal bispecific antibody

Experimental: Part B: XmAb18087 + pembrolizumab
Part B, will enroll subjects with advanced MCC not previously treated with anti-programmed cell death 1 (PD1) or anti-programmed cell death ligand 1 (PDL1) agents, consists of safety run-in cohorts followed by an expansion cohort.
Drug: XmAb18087 ± Pembrolizumab
XmAb18087 ± Pembrolizumab

Experimental: Part C: XmAb18087 monotherapy
Part C will enroll subjects with previously treated extensive-stage SCLC and consists of safety-run in cohorts followed by an expansion cohort.
Biological: XmAb18087
Monoclonal bispecific antibody




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (safety), graded by CTCAE version 5.0 [ Time Frame: 42 Days ]
    Determine the rates of treatment-emergent adverse events as graded by CTAE version 5.0

  2. ORR, CR rate and PR rate as assessed by RECIST 1.1 criteria (efficacy) [ Time Frame: 42 Days ]
    Determine the overall response rate (ORR), complete response (CR) rate and partial response (PR) rate, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04590781


Contacts
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Contact: Zequn Tang, MD, PhD 858-480-3672 ext 672 ttang@xencor.com
Contact: Gabrielle Golden 858-480-3121 ext 221 ggolden@xencor.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Yan Xin, MD    626-218-3582    yxing@coh.org   
Contact: Doni Woo    626-218-3582    DWoo@coh.org   
USC/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Gino In, MD    323-865-3000    Gino.In@med.usc.edu   
Contact: Carryl DuBois    323 865 3084    Carryl.DuBois@med.usc.edu   
United States, Oklahoma
Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Raid Aljumaily, MD    405-271-1632    Raid-Aljumaily@ouhsc.edu   
Contact: Christina Caldwell, LPN    405 271 8001 ext 48171      
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98109
Contact: Shailender Bhatia, MD    206-606-6326    renmelpc@seattlecca.org   
Contact: Sam Kiriuk    206-606-7341    smlim@seattlecca.org   
Sponsors and Collaborators
Xencor, Inc.
ICON plc
Investigators
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Study Director: Barbara Hickingbottom, MD Vice President, Clinical Development, Xencor
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Responsible Party: Xencor, Inc.
ClinicalTrials.gov Identifier: NCT04590781    
Other Study ID Numbers: XmAb18087-02
DUET 1-02 ( Other Identifier: Xencor )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xencor, Inc.:
MCC
SCLC
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Bronchial Neoplasms
Tumor Virus Infections
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Carcinoma, Merkel Cell
Carcinoma
Small Cell Lung Carcinoma
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Infections
Adenocarcinoma
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents