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

Primary Purpose

Merkel Cell Carcinoma, Small Cell Lung Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

XmAb18087

XmAb18087 ± Pembrolizumab

About this trial

This is an interventional treatment trial for Merkel Cell Carcinoma focused on measuring MCC, SCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

City of Hope
USC/Norris Comprehensive Cancer Center
Dartmouth Hitchcock Medical Center
Memorial Sloan Kettering
OU Health, Stephenson Cancer Center
Swedish Cancer Institute
University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Part A: XmAb18087 Monotherapy

Part B: XmAb18087 + pembrolizumab

Part C: XmAb18087 monotherapy

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events

A treatment-emergent adverse event (TEAE) was any untoward medical occurrence in a participant treated with study drug. The TEAE does not necessarily have a causal relationship with this treatment. A TEAE can therefore be any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. TEAEs may include the onset of new illness and the exacerbation of preexisting conditions. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section."

Overall Response Rate as Assessed by RECIST 1.1 Criteria

Complete and Partial Response Rate as Assessed by RECIST 1.1 Criteria

Secondary Outcome Measures

Duration of Response

Progression-free Survival as Assessed by Per RECIST 1.1 Criteria

Overall Survival as Assessed by Per RECIST 1.1 Criteria

Pharmacokinetics: Maximum Observed Serum Concentration

Immunogenicity: Number of Participants With Anti-XmAb18087 Antibodies

Full Information

NCT ID

NCT04590781

First Posted

October 5, 2020

Last Updated

March 30, 2023

Sponsor

Xencor, Inc.

Collaborators

ICON plc

1. Study Identification

Unique Protocol Identification Number

NCT04590781

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Terminated

Why Stopped

The study has been terminated early by the sponsor due to business decision.

Study Start Date

May 10, 2021 (Actual)

Primary Completion Date

March 24, 2022 (Actual)

Study Completion Date

March 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xencor, Inc.

Collaborators

ICON plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Merkel Cell Carcinoma, Small Cell Lung Cancer

Keywords

MCC, SCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A: XmAb18087 Monotherapy

Arm Type

Experimental

Arm Description

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

Arm Title

Part B: XmAb18087 + pembrolizumab

Arm Type

Experimental

Arm Description

Arm Title

Part C: XmAb18087 monotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

XmAb18087

Intervention Description

Monoclonal bispecific antibody

Intervention Type

Drug

Intervention Name(s)

XmAb18087 ± Pembrolizumab

Intervention Description

XmAb18087 ± Pembrolizumab

Primary Outcome Measure Information:

Title

Number of Participants With Treatment-emergent Adverse Events

Description

Time Frame

Day 1 (after dosing) up to end of study (up to 163 days)

Title

Overall Response Rate as Assessed by RECIST 1.1 Criteria

Time Frame

Up to end of study (up to 163 days)

Title

Complete and Partial Response Rate as Assessed by RECIST 1.1 Criteria

Time Frame

Up to end of study (up to 163 days)

Secondary Outcome Measure Information:

Title

Duration of Response

Time Frame

Up to end of study (up to 163 days)

Title

Progression-free Survival as Assessed by Per RECIST 1.1 Criteria

Time Frame

Up to end of study (up to 163 days)

Title

Overall Survival as Assessed by Per RECIST 1.1 Criteria

Time Frame

Up to end of study (up to 163 days)

Title

Pharmacokinetics: Maximum Observed Serum Concentration

Time Frame

Predose up to end of study (up to 163 days)

Title

Immunogenicity: Number of Participants With Anti-XmAb18087 Antibodies

Time Frame

Up to end of study (up to 163 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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: • Participants must have progressed on or been ineligible for treatment with anti-PD1 or anti-PDL1 therapy. Additional Inclusion Criteria for Part B Cohorts: • Participants 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin Thompson, MD, PhD

Organizational Affiliation

Medical Director, Clinical Development, Xencor

Official's Role

Study Director

Facility Information:

Facility Name

City of Hope

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

USC/Norris Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Dartmouth Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Memorial Sloan Kettering

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

OU Health, Stephenson Cancer Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Swedish Cancer Institute

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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