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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Monoclonal bispecific antibody
XmAb18087 ± Pembrolizumab
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
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."
Time frame: Day 1 (after dosing) up to end of study (up to 163 days)
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)
Duration of Response
Time frame: Up to end of study (up to 163 days)
Progression-free Survival as Assessed by Per RECIST 1.1 Criteria
Time frame: Up to end of study (up to 163 days)
Overall Survival as Assessed by Per RECIST 1.1 Criteria
Time frame: Up to end of study (up to 163 days)
Pharmacokinetics: Maximum Observed Serum Concentration
Time frame: Predose up to end of study (up to 163 days)
Immunogenicity: Number of Participants With Anti-XmAb18087 Antibodies
Time frame: Up to end of study (up to 163 days)
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