Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Infections

Symptoms and General Pathology

Rare Diseases

Carcinoma

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma, Merkel Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Small Cell Lung Cancer

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Pembrolizumab

Antibodies, Bispecific

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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.

XmAb18087

XmAb18087 ± Pembrolizumab

Benjamin Thompson, MD, PhD

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.

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

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

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."

ICON plc

Xencor, Inc.

Participants with previously treated advanced MCC were administered XmAb18087 Monotherapy.

Part A: XmAb18087 Monotherapy

Participants with previously treated extensive-stage SCLC were administered XmAb18087 monotherapy.

Part C: XmAb18087 Monotherapy

Total

Age, Categorical

Sex: Female, Male

No data is reported here to maintain participant confidentiality.

Ethnicity (NIH/OMB)

Race (NIH/OMB)

All participants who received at least 1 dose of XmAb18087.

Study was terminated by the sponsor and only 2 participants each were enrolled in Parts A and C. No participants were enrolled for Part B. Data were not collected for the prespecified analyses of efficacy, pharmacokinetics, and immunogenicity outcome measures.

All participants who received at least 1 dose of XmAb18087. No participants were enrolled for Part B, therefore, only Parts A and C results are reported.

Number of Participants With Treatment-emergent Adverse Events

Data were not collected for the prespecified analysis of this outcome measure. No participants were enrolled for Part B.

Overall Response Rate as Assessed by RECIST 1.1 Criteria

Complete and Partial Response Rate as Assessed by RECIST 1.1 Criteria

Duration of Response

Progression-free Survival as Assessed by Per RECIST 1.1 Criteria

Data was not collected for the prespecified analysis of this outcome measure. No participants were enrolled for Part B.

Overall Survival as Assessed by Per RECIST 1.1 Criteria

Participants administered XmAb18087 Monotherapy.

XmAb18087 Monotherapy

Analysis was not performed as data were not collected for this outcome measure due to early study termination. No participants were enrolled for Part B.

Pharmacokinetics: Maximum Observed Serum Concentration

Immunogenicity: Number of Participants With Anti-XmAb18087 Antibodies

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer	NCT04590781	Merkel Cell Car... Small Cell Lung...	XmAb18087 XmAb18087 ± Pem...	18 Years -	Xencor, Inc.
Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer	NCT04590781	Merkel Cell Car... Small Cell Lung...	XmAb18087 XmAb18087 ± Pem...	18 Years -	Xencor, Inc.
Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer	NCT04590781	Merkel Cell Car... Small Cell Lung...	XmAb18087 XmAb18087 ± Pem...	18 Years -	Xencor, Inc.
Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer	NCT04590781	Merkel Cell Car... Small Cell Lung...	XmAb18087 XmAb18087 ± Pem...	18 Years -	Xencor, Inc.

Spots Global Cancer Trial Database for xmab18087 ± pembrolizumab