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

NCT ID: NCT04590781

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2022-03-24

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 participants with metastatic Merkel cell (MCC) or locoregional MCC that has recurred after locoregional therapy with surgery and/or radiation therapy, and mAb18087 monotherapy in participants with extensive-stage small cell lung cancer (SCLC) that has progressed after standard therapies.

This study was terminated by the sponsor. No participants enrolled in Part B.

Conditions

Merkel Cell Carcinoma; Small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: XmAb18087 Monotherapy

Part A, will enroll participants with previously treated advanced MCC, consists of safety-run in cohorts followed by an expansion cohort.

Group Type: EXPERIMENTAL

XmAb18087

Intervention Type: BIOLOGICAL

Monoclonal bispecific antibody

Part B: XmAb18087 + pembrolizumab

Part B, will enroll participants 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.

Group Type: EXPERIMENTAL

XmAb18087 ± Pembrolizumab

Intervention Type: DRUG

XmAb18087 ± Pembrolizumab

Part C: XmAb18087 monotherapy

Part C will enroll participants with previously treated extensive-stage SCLC and consists of safety-run in cohorts followed by an expansion cohort.

Group Type: EXPERIMENTAL

XmAb18087

Intervention Type: BIOLOGICAL

Monoclonal bispecific antibody

Interventions

XmAb18087

Monoclonal bispecific antibody

Intervention Type: BIOLOGICAL

XmAb18087 ± Pembrolizumab

XmAb18087 ± Pembrolizumab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Able to provide written informed consent
• Adult participants ≥ 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 participants 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 participants 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 participants 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

• Histologically or cytologically confirmed metastatic MCC or locoregional MCC that has recurred following standard locoregional therapy with surgery and/or radiation therapy.

• Participants must have progressed on or been ineligible for treatment with anti-PD1 or anti-PDL1 therapy.

• Participants must be eligible to receive pembrolizumab as standard of care.

• Histologically or cytologically confirmed extensive-stage SCLC that has progressed following standard therapies

Exclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ICON plc

INDUSTRY

Sponsor Role: collaborator

Xencor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Thompson, MD, PhD

Role: STUDY_DIRECTOR

Medical Director, Clinical Development, Xencor

Locations

City of Hope

Duarte, California, United States

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Memorial Sloan Kettering

New York, New York, United States

OU Health, Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Swedish Cancer Institute

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DUET 1-02

Identifier Type: OTHER

Identifier Source: secondary_id

XmAb18087-02

Identifier Type: -

Identifier Source: org_study_id