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
Overview
- Phase
- Phase 1
- Intervention
- XmAb18087
- Conditions
- Merkel Cell Carcinoma
- Sponsor
- Xencor, Inc.
- Enrollment
- 4
- Locations
- 7
- Primary Endpoint
- Number of Participants With Treatment-emergent Adverse Events
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
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
Arms & Interventions
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.
Intervention: XmAb18087
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.
Intervention: 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.
Intervention: XmAb18087
Outcomes
Primary Outcomes
Number of Participants With Treatment-emergent Adverse Events
Time Frame: Day 1 (after dosing) up to end of study (up to 163 days)
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
Time Frame: Up to end of study (up to 163 days)
Complete and Partial Response Rate as Assessed by RECIST 1.1 Criteria
Time Frame: Up to end of study (up to 163 days)
Secondary Outcomes
- Duration of Response(Up to end of study (up to 163 days))
- Progression-free Survival as Assessed by Per RECIST 1.1 Criteria(Up to end of study (up to 163 days))
- Overall Survival as Assessed by Per RECIST 1.1 Criteria(Up to end of study (up to 163 days))
- Pharmacokinetics: Maximum Observed Serum Concentration(Predose up to end of study (up to 163 days))
- Immunogenicity: Number of Participants With Anti-XmAb18087 Antibodies(Up to end of study (up to 163 days))