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

• Sponsor: Xencor, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04590781
• Collaborator: ICON plc (Industry)
• Enrollment: 4
• Locations: 7
• Arms: 3
• Actual Duration (Months): 10.4
• Patients Per Site: 0.6
• Patients Per Site Per Month: 0.1

Study Details

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 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

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 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
• Actual Primary Completion Date: Mar 24, 2022
• Actual Study Completion Date: Mar 24, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of treatment-emergent adverse events (safety), graded by CTCAE version 5.0 [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) [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	USC/Norris Comprehensive Cancer Center	Los Angeles	California	United States	90033
3	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
4	Memorial Sloan Kettering	New York	New York	United States	10065
5	OU Health, Stephenson Cancer Center	Oklahoma City	Oklahoma	United States	73104
6	Swedish Cancer Institute	Seattle	Washington	United States	98109
7	University of Washington	Seattle	Washington	United States	98109

Sponsors and Collaborators

• Xencor, Inc.
• ICON plc

Investigators

• Study Director: Zequn Tang, MD, PhD, Senior Medical Director, Clinical Development, Xencor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xencor, Inc.
• ClinicalTrials.gov Identifier: NCT04590781
• Other Study ID Numbers: XmAb18087-02; DUET 1-02
• First Posted: Oct 19, 2020
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Carcinoma, Merkel Cell; Carcinoma; Lung Neoplasms; Small Cell Lung Carcinoma; Pembrolizumab

Study Results

No Results Posted as of Aug 9, 2022