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| ID | Type | Description | Link |
|---|---|---|---|
| DUET 1-02 | Other Identifier | Xencor |
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The study has been terminated early by the sponsor due to business decision.
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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: XmAb18087 Monotherapy | Experimental | Part A, will enroll participants with previously treated advanced MCC, consists of safety-run in cohorts followed by an expansion cohort. |
|
| Part B: XmAb18087 + pembrolizumab | Experimental | 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: XmAb18087 monotherapy | Experimental | Part C will enroll participants with previously treated extensive-stage SCLC and consists of safety-run in cohorts followed by an expansion cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XmAb18087 | Biological | Monoclonal bispecific antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Overall Response Rate as Assessed by RECIST 1.1 Criteria | Up to end of study (up to 163 days) | |
| Complete and Partial Response Rate as Assessed by RECIST 1.1 Criteria | Up to end of study (up to 163 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Thompson, MD, PhD | Medical Director, Clinical Development, Xencor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| USC/Norris Comprehensive Cancer Center |
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The study has been terminated early by the sponsor. No participants with advanced Merkel Cell Carcinoma (MCC) not previously treated with anti-programmed cell death 1 (PD1) or anti-programmed cell death ligand 1 (PDL1) agents were enrolled for Part B.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: XmAb18087 Monotherapy | Participants with previously treated advanced MCC were administered XmAb18087 Monotherapy. |
| FG001 | Part C: XmAb18087 Monotherapy | Participants with previously treated extensive-stage SCLC were administered XmAb18087 monotherapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 18, 2020 | Feb 23, 2023 |
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| XmAb18087 ± Pembrolizumab | Drug | XmAb18087 ± Pembrolizumab |
|
| 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) |
| Los Angeles |
| California |
| 90033 |
| United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Memorial Sloan Kettering | New York | New York | 10065 | United States |
| OU Health, Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98109 | United States |
| University of Washington | Seattle | Washington | 98109 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All participants who received at least 1 dose of XmAb18087.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: XmAb18087 Monotherapy | Participants with previously treated advanced MCC were administered XmAb18087 Monotherapy. |
| BG001 | Part C: XmAb18087 Monotherapy | Participants with previously treated extensive-stage SCLC were administered XmAb18087 monotherapy. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | No data is reported here to maintain participant confidentiality. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | No data is reported here to maintain participant confidentiality. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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." | 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. | Posted | Count of Participants | Participants | Day 1 (after dosing) up to end of study (up to 163 days) |
|
|
| |||||||||||||||||||||||||||||
| Primary | Overall Response Rate as Assessed by RECIST 1.1 Criteria | Data were not collected for the prespecified analysis of this outcome measure. No participants were enrolled for Part B. | Posted | Up to end of study (up to 163 days) |
|
| |||||||||||||||||||||||||||||||||
| Primary | Complete and Partial Response Rate as Assessed by RECIST 1.1 Criteria | Data were not collected for the prespecified analysis of this outcome measure. No participants were enrolled for Part B. | Posted | Up to end of study (up to 163 days) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Data were not collected for the prespecified analysis of this outcome measure. No participants were enrolled for Part B. | Posted | Up to end of study (up to 163 days) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival as Assessed by Per RECIST 1.1 Criteria | Data were not collected for the prespecified analysis of this outcome measure. No participants were enrolled for Part B. | Posted | Up to end of study (up to 163 days) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Overall 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. | Posted | Up to end of study (up to 163 days) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics: Maximum Observed Serum Concentration | 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. | Posted | Predose up to end of study (up to 163 days) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Immunogenicity: Number of Participants With Anti-XmAb18087 Antibodies | 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. | Posted | Up to end of study (up to 163 days) |
|
|
Day 1 (after dosing) up to end of study (up to 163 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: XmAb18087 Monotherapy | Participants with previously treated advanced MCC were administered XmAb18087 Monotherapy. | 0 | 2 | 2 | 2 | 2 | 2 |
| EG001 | Part C: XmAb18087 Monotherapy | Participants with previously treated extensive-stage SCLC were administered XmAb18087 monotherapy. | 2 | 2 | 2 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oesophageal motility disorder | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| gamma-glutamyltransferase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Thompson, MD, PhD | Xencor, Inc | 858-480-3133 | 433 | bthompson@xencor.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 29, 2022 | Feb 23, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015266 | Carcinoma, Merkel Cell |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Between 18 and 65 years |
|
| >=65 years |
|
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|
|