Trial · NCT03436732
Mesothelin-Targeted Immunotoxin LMB-100 in Combination With SEL-110 in Subjects With Malignant Pleural or Peritoneal Mesothelioma
NCT03436732, Phase 1, Terminated, National Cancer Institute (NCI); results first posted 2019-11-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Mesothelin-Targeted Immunotoxin LMB-100 in Combination With SEL-110 in Subjects With Malignant Pleural or Peritoneal Mesothelioma. Trials, record NCT03436732. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03436732
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mesothelin-Targeted Immunotoxin LMB-100 in Combination With SEL-110 in Subjects With Malignant Pleural or Peritoneal Mesothelioma
- NCT number
- NCT03436732
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 5 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Mesothelioma
- Interventions
- LMB-100, SEL-110
- First posted
- 2018-02-19
- Last updated
- 2019-11-22
- Results first posted
- 2019-11-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Grade ≥3 Adverse Events Related to Study Drug at Dose Level 140 mcg/kg and 100 mcg/kg | Day 85 | Here are the grade ≥3 adverse events at each dose level assessed by the Common Terminology Criteria in Adverse Events CTCAE v5.0. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 3 is Severe or medically significant but not immediately life-threatening;hospitalization or prolongation of hospitalization indicated; disabling;limiting self care ADL (i.e., bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. Grade 4 is life-threatening consequences;urgent intervention indicated. Grade 5 is death related to adverse event. |
| Primary | Maximum Tolerated Dose (MTD) | Day 21 | MTD is defined as the highest tested dose of LMB-100 and SEL-110 at which no more than 1 of 6 subjects experience a dose limiting toxicity. A dose limiting toxicity is defined as any of the following: Grade 4 neutropenia for a minimum duration of 7 days. Grade 4 thrombocytopenia (≤25.0 x 10(9) cells/L), Grade 3 thrombocytopenia associated with bleeding episodes, and Grade 4 anemia. Grade ≥3 non-hematological toxicity with the exception of Alopecia (any grade), Grade 3 nausea and vomiting lasting \> 48 hours despite appropriate treatment, Grade 3 diarrhea lasting for ≤ 2 days with no fever or dehydration, and laboratory values of ≥ grade 3 that are judged not clinically significant by the investigator. Any other drug related toxicity considered significant enough to be qualified as a DLT in the opinion of the principal investigator. Inability to start cycle 2 within 3 weeks after completing cycle 1 due to drug-related adverse events. |
| Secondary | Number of Participants With Partial Response or Complete Response (PR + CR) | 42 days | Response is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesion, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Fraction of Participants With Detectable LMB-100 in Blood After Cycle 4 | Day 85 | Blood is measured for a detectable level of LMB-100 in the blood. LMB-100 is either detectable in the blood or not. A detectable level of LMB-100 in the blood is considered a desirable outcome for the participant. Hence, the reverse is not a considered a desirable outcome for the participant. |
| Secondary | Number of Participants With Serious and Non-Serious Adverse Events | Date treatment consent signed to date off study, approximately one month and 25 days for the 100 mcg/kg Arm/Group, and 9 months and 28 days for the 140 mcg/kg Arm/Group. | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Grade ≥3 Adverse Events Related to Study Drug at Dose Level 140 mcg/kg and 100 mcg/kg | Day 85 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Maximum Tolerated Dose (MTD) | Day 21 | MTD was not found because the study was closed due to a fatal occurrence of pneumonitis that was attributed to one of the study drugs. | ||
| SECONDARY | Number of Participants With Partial Response or Complete Response (PR + CR) | 42 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Fraction of Participants With Detectable LMB-100 in Blood After Cycle 4 | Day 85 | This outcome measure was not done because the study was closed due to a fatal occurrence of pneumonitis that was attributed to one of the study drugs. | ||
| SECONDARY | Number of Participants With Serious and Non-Serious Adverse Events | Date treatment consent signed to date off study, approximately one month and 25 days for the 100 mcg/kg Arm/Group, and 9 months and 28 days for the 140 mcg/kg Arm/Group. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Grade ≥3 Adverse Events Related to Study Drug at Dose Level 140 mcg/kg and 100 mcg/kg | 140 mcg/kg | Grade 4 pericardial effusion | 1 | Participants | |
| Number of Participants With Grade ≥3 Adverse Events Related to Study Drug at Dose Level 140 mcg/kg and 100 mcg/kg | 100 mcg/kg | Grade 4 pericardial effusion | 0 | Participants | |
| Number of Participants With Grade ≥3 Adverse Events Related to Study Drug at Dose Level 140 mcg/kg and 100 mcg/kg | 140 mcg/kg | Grade 5 pneumonitis | 0 | Participants | |
| Number of Participants With Grade ≥3 Adverse Events Related to Study Drug at Dose Level 140 mcg/kg and 100 mcg/kg | 100 mcg/kg | Grade 5 pneumonitis | 1 | Participants | |
| Number of Participants With Partial Response or Complete Response (PR + CR) | 140 mcg/kg | Partial Response | 0 | Participants | |
| Number of Participants With Partial Response or Complete Response (PR + CR) | 100 mcg/kg | Partial Response | 0 | Participants | |
| Number of Participants With Partial Response or Complete Response (PR + CR) | 140 mcg/kg | Complete Response | 0 | Participants | |
| Number of Participants With Partial Response or Complete Response (PR + CR) | 100 mcg/kg | Complete Response | 0 | Participants | |
| Number of Participants With Serious and Non-Serious Adverse Events | 140 mcg/kg | 3 | Participants | ||
| Number of Participants With Serious and Non-Serious Adverse Events | 100 mcg/kg | 1 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 140 mcg/kg LMB-100 + SEL-110 | 4 | |
| Overall Study | STARTED | 100 mcg/kg LMB-100 + SEL-110 | 1 | |
| Overall Study | COMPLETED | 140 mcg/kg LMB-100 + SEL-110 | 0 | |
| Overall Study | COMPLETED | 100 mcg/kg LMB-100 + SEL-110 | 0 | |
| Overall Study | NOT COMPLETED | 140 mcg/kg LMB-100 + SEL-110 | 4 | |
| Overall Study | NOT COMPLETED | 100 mcg/kg LMB-100 + SEL-110 | 1 |
Source ClinicalTrials.gov
Adverse events144
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Activated partial thromboplastin time prolonged | Investigations | 140 mcg/kg LMB-100 + SEL-110 | 1 | 4 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | 100 mcg/kg LMB-100 + SEL-110 | 1 | 1 | 1 |
| other | Alanine aminotransferase increased | Investigations | 140 mcg/kg LMB-100 + SEL-110 | 2 | 4 | 3 |
| other | Alanine aminotransferase increased | Investigations | 100 mcg/kg LMB-100 + SEL-110 | 0 | 1 | 0 |
| other | Alkaline phosphatase increased | Investigations | 140 mcg/kg LMB-100 + SEL-110 | 1 | 4 | 2 |
| other | Alkaline phosphatase increased | Investigations | 100 mcg/kg LMB-100 + SEL-110 | 0 | 1 | 0 |
| other | Anemia | Blood and lymphatic system disorders | 140 mcg/kg LMB-100 + SEL-110 | 2 | 4 | 2 |
| other | Anemia | Blood and lymphatic system disorders | 100 mcg/kg LMB-100 + SEL-110 | 1 | 1 | 4 |
| other | Anorexia | Metabolism and nutrition disorders | 140 mcg/kg LMB-100 + SEL-110 | 1 | 4 | 1 |
| other | Anorexia | Metabolism and nutrition disorders | 100 mcg/kg LMB-100 + SEL-110 | 1 | 1 | 1 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 140 mcg/kg LMB-100 + SEL-110 | 2 | 4 |
| Total, all-cause mortality | 100 mcg/kg LMB-100 + SEL-110 | 1 | 1 |
| Total, other adverse events | 140 mcg/kg LMB-100 + SEL-110 | 3 | 4 |
| Total, other adverse events | 100 mcg/kg LMB-100 + SEL-110 | 1 | 1 |
| Total, serious adverse events | 140 mcg/kg LMB-100 + SEL-110 | 3 | 4 |
| Total, serious adverse events | 100 mcg/kg LMB-100 + SEL-110 | 1 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 140 mcg/kg vs 100 mcg/kg: Number of Participants With Serious and Non-Serious Adverse Events | Trial comparisons |
| 140 mcg/kg LMB-100 + SEL-110 vs 100 mcg/kg LMB-100 + SEL-110: deaths from any cause | Trial comparisons |
| 140 mcg/kg LMB-100 + SEL-110 vs 100 mcg/kg LMB-100 + SEL-110: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03436732
GET https://conductscience.org/api/trials/v1/NCT03436732/events?page=2