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

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04590781
• Other study ID #: XmAb18087-02
• Secondary ID: DUET 1-02
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 10, 2021
• Est. completion date: March 24, 2022

Study information

• Verified date: March 2023
• Source: Xencor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 24, 2022
• Est. primary completion date: March 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Merkel Cell
• Lung Neoplasms
• Merkel Cell Carcinoma
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Biological:
• XmAb18087
Monoclonal bispecific antibody

Drug:
• XmAb18087 ± Pembrolizumab
XmAb18087 ± Pembrolizumab

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
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

Sponsors (2)

Lead Sponsor	Collaborator
Xencor, Inc.	ICON plc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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."	Day 1 (after dosing) up to end of study (up to 163 days)
Primary	Overall Response Rate as Assessed by RECIST 1.1 Criteria		Up to end of study (up to 163 days)
Primary	Complete and Partial Response Rate as Assessed by RECIST 1.1 Criteria		Up to end of study (up to 163 days)
Secondary	Duration of Response		Up to end of study (up to 163 days)
Secondary	Progression-free Survival as Assessed by Per RECIST 1.1 Criteria		Up to end of study (up to 163 days)
Secondary	Overall Survival as Assessed by Per RECIST 1.1 Criteria		Up to end of study (up to 163 days)
Secondary	Pharmacokinetics: Maximum Observed Serum Concentration		Predose up to end of study (up to 163 days)
Secondary	Immunogenicity: Number of Participants With Anti-XmAb18087 Antibodies		Up to end of study (up to 163 days)