Trial Outcomes & Findings for Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer (NCT NCT04590781)
NCT ID: NCT04590781
Last Updated: 2023-04-20
Results Overview
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."
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Day 1 (after dosing) up to end of study (up to 163 days)
Results posted on
2023-04-20
Participant Flow
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.
Participant milestones
| Measure |
Part A: XmAb18087 Monotherapy
Participants with previously treated advanced MCC were administered XmAb18087 Monotherapy.
|
Part C: XmAb18087 Monotherapy
Participants with previously treated extensive-stage SCLC were administered XmAb18087 monotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Part A: XmAb18087 Monotherapy
Participants with previously treated advanced MCC were administered XmAb18087 Monotherapy.
|
Part C: XmAb18087 Monotherapy
Participants with previously treated extensive-stage SCLC were administered XmAb18087 monotherapy.
|
|---|---|---|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
No data is reported here to maintain participant confidentiality.
Baseline characteristics by cohort
| Measure |
Part A: XmAb18087 Monotherapy
n=2 Participants
Participants with previously treated advanced MCC were administered XmAb18087 Monotherapy.
|
Part C: XmAb18087 Monotherapy
n=2 Participants
Participants with previously treated extensive-stage SCLC were administered XmAb18087 monotherapy.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
—
|
0 Participants
No data is reported here to maintain participant confidentiality.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
—
|
0 Participants
No data is reported here to maintain participant confidentiality.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
No data is reported here to maintain participant confidentiality.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
—
|
0 Participants
No data is reported here to maintain participant confidentiality.
|
|
Race (NIH/OMB)
Asian
|
—
|
—
|
0 Participants
No data is reported here to maintain participant confidentiality.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
—
|
0 Participants
No data is reported here to maintain participant confidentiality.
|
|
Race (NIH/OMB)
Black or African American
|
—
|
—
|
0 Participants
No data is reported here to maintain participant confidentiality.
|
|
Race (NIH/OMB)
White
|
—
|
—
|
0 Participants
No data is reported here to maintain participant confidentiality.
|
|
Race (NIH/OMB)
More than one race
|
—
|
—
|
0 Participants
No data is reported here to maintain participant confidentiality.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
—
|
0 Participants
No data is reported here to maintain participant confidentiality.
|
PRIMARY outcome
Timeframe: Day 1 (after dosing) up to end of study (up to 163 days)Population: 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.
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."
Outcome measures
| Measure |
Part A: XmAb18087 Monotherapy
n=2 Participants
Participants with previously treated advanced MCC were administered XmAb18087 Monotherapy.
|
Part C: XmAb18087 Monotherapy
n=2 Participants
Participants with previously treated extensive-stage SCLC were administered XmAb18087 monotherapy.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to end of study (up to 163 days)Population: Data were not collected for the prespecified analysis of this outcome measure. No participants were enrolled for Part B.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to end of study (up to 163 days)Population: Data were not collected for the prespecified analysis of this outcome measure. No participants were enrolled for Part B.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of study (up to 163 days)Population: Data were not collected for the prespecified analysis of this outcome measure. No participants were enrolled for Part B.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of study (up to 163 days)Population: Data were not collected for the prespecified analysis of this outcome measure. No participants were enrolled for Part B.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of study (up to 163 days)Population: Data was not collected for the prespecified analysis of this outcome measure. No participants were enrolled for Part B.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose up to end of study (up to 163 days)Population: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to end of study (up to 163 days)Population: 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.
Outcome measures
Outcome data not reported
Adverse Events
Part A: XmAb18087 Monotherapy
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Part C: XmAb18087 Monotherapy
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Part A: XmAb18087 Monotherapy
n=2 participants at risk
Participants with previously treated advanced MCC were administered XmAb18087 Monotherapy.
|
Part C: XmAb18087 Monotherapy
n=2 participants at risk
Participants with previously treated extensive-stage SCLC were administered XmAb18087 monotherapy.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
100.0%
2/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Gastrointestinal disorders
Oesophageal motility disorder
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
Other adverse events
| Measure |
Part A: XmAb18087 Monotherapy
n=2 participants at risk
Participants with previously treated advanced MCC were administered XmAb18087 Monotherapy.
|
Part C: XmAb18087 Monotherapy
n=2 participants at risk
Participants with previously treated extensive-stage SCLC were administered XmAb18087 monotherapy.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
100.0%
2/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Gastrointestinal disorders
Gastritis
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Gastrointestinal disorders
Haemorrhoids
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
General disorders
Asthenia
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
General disorders
Chills
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
100.0%
2/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
General disorders
Fatigue
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
General disorders
Oedema peripheral
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Immune system disorders
Cytokine release syndrome
|
100.0%
2/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Infections and infestations
Cellulitis
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Infections and infestations
Skin infection
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Infections and infestations
Urinary tract infection
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Investigations
gamma-glutamyltransferase increased
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Investigations
Lipase increased
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Investigations
Weight decreased
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Nervous system disorders
Dysarthria
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Psychiatric disorders
Confusional state
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Renal and urinary disorders
Bladder spasm
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Renal and urinary disorders
Haematuria
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Renal and urinary disorders
Urinary incontinence
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
50.0%
1/2 • Day 1 (after dosing) up to end of study (up to 163 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place