Trial · NCT02810418
Mesothelin-Targeted Immunotoxin LMB-100 Alone or in Combination With Nab-Paclitaxel in People With Previously Treated Metastatic and/or Locally Advanced Pancreatic Ductal Adenocarcinoma and Mesothelin Expressing Solid Tumors
NCT02810418, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2021-02-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Mesothelin-Targeted Immunotoxin LMB-100 Alone or in Combination With Nab-Paclitaxel in People With Previously Treated Metastatic and/or Locally Advanced Pancreatic Ductal Adenocarcinoma and Mesothelin Expressing Solid Tumors. Trials, record NCT02810418. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02810418
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Mesothelin-Targeted Immunotoxin LMB-100 Alone or in Combination With Nab-Paclitaxel in People With Previously Treated Metastatic and/or Locally Advanced Pancreatic Ductal Adenocarcinoma and Mesothelin Expressing Solid Tumors
- NCT number
- NCT02810418
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Neoplasms, Pancreatic Neoplasms
- Interventions
- LMB-100, Nab-Paclitaxel, Mesothelin Expression, LMB-100
- First posted
- 2016-06-23
- Last updated
- 2022-03-15
- Results first posted
- 2021-02-02
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response (OR) (Partial Responses + Complete Responses) in Phase 2 Subjects of Short Infusion LMB-100+ Nab-paclitaxel | Approximately 6 weeks after the start of treatment and continuing every 6 weeks until progression or start of a new treatment, up to 1 year | OR is defined as partial responses + complete response in participants in the phase 2 Arm A portion of the study assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete Response is a disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters |
| Primary | Maximum Tolerated Dose (MTD) of Short Infusion LMB-100 + Nab Paclitaxel | 21 days after LMB-100 is administered (end of cycle 1) | MTD is defined as the highest dose tolerated without exceeding a pre-set number of adverse events in Phase 1, Arm A. |
| Primary | Maximum Tolerated Dose (MTD) of Continuous Infusion LMB-100 | 21 days after LMB-100 is administered (end of cycle 1) | MTD is defined as the highest dose tolerated without exceeding a pre-set number of adverse events in Phase 1, 1 Arm B, single agent lead-in |
| Secondary | Progression Free Survival (PFS) | Time from treatment initiation to disease progression or death, an average of 1 year. | PFS is the average time from treatment initiation to disease progression or death. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. And the appearance of one or more new lesions. |
| Secondary | Overall Survival (OS) | Time from treatment initiation to death, up to 1-2 years. | OS is the average time from treatment initiation to death. |
| Secondary | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | up to 3 months | DCR is the proportion of participants with stable disease, partial response or complete response at end of treatment. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. |
| Secondary | Number of Participants With an Objective Response (OR) (Partial Responses + Complete Responses) in Phase 1 Arm A1 | Approximately 6 weeks after the start of treatment and continuing every 6 weeks until progression or start of a new treatment up to 1 year. | OR is defined as partial response + complete response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete Response is a disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters |
| Secondary | Number of Participants With an Objective Response (OR) (Partial Response + Complete Response) in Phase 1, Arm B | Approximately 6 weeks after the start of treatment and continuing every 6 weeks until progression or start of a new treatment up to 1 year. | OR is defined as partial responses + complete response in participants in the phase 1 Arm B portion of the study assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete Response is a disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Number of Participants With Adverse Events Attributed to LMB-100 | Date treatment consent signed to date off study, approx. 11 mos, 8 days for A1DL1; 20 mos, 9 days for A1DL-1; 10 mos, 17 days for A2; 2 mos, 16 days for B1DL1; 14 mos, 30 days for B1DL2; 5 mos, 1 day for B2; and 4 mos, 15 days for B1DL3R. | Grade 1-4 adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 observed in subjects with pancreatic cancer. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe or medically significant. Grade 4 is life-threatening consequences. |
| Secondary | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Date treatment consent signed to date off study, approx. 11 mos, 8 days for A1DL1; 20 mos, 9 days for A1DL-1; 10 mos, 17 days for A2; 2 mos, 16 days for B1DL1; 14 mos, 30 days for B1DL2; 5 mos, 1 day for B2; and 4 mos, 15 days for B1DL3R. | Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response (OR) (Partial Responses + Complete Responses) in Phase 2 Subjects of Short Infusion LMB-100+ Nab-paclitaxel | Approximately 6 weeks after the start of treatment and continuing every 6 weeks until progression or start of a new treatment, up to 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Maximum Tolerated Dose (MTD) of Short Infusion LMB-100 + Nab Paclitaxel | 21 days after LMB-100 is administered (end of cycle 1) | µg/kg | NUMBER | |
| PRIMARY | Maximum Tolerated Dose (MTD) of Continuous Infusion LMB-100 | 21 days after LMB-100 is administered (end of cycle 1) | Arm B2, Phase I, 24-hour continuous infusion combination therapy is not reported here because MTD was only assessed in the Phase I, Arm B single agent lead-in Arm/Groups.~Please note: Dose 100 (µg/kg/day), for duration (24 Hours), schedule Days 1 \& 4, preceded by a 40 mcg/kg loading dose over 30 minutes, was determined to be the preferred schedule. | Dose (µg/kg) | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Time from treatment initiation to disease progression or death, an average of 1 year. | It was specified in the protocol that patients enrolled in Arm A1 who received the maximum tolerated dose (MTD) should be included for PFS endpoint analysis of Arm A2 data. Therefore, 8 (Arm A1, DL-1) + 6 (Arm A2) = 14 patients were included in the Arm 2 PFS analysis. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Time from treatment initiation to death, up to 1-2 years. | Arm/Groups A1 and B1 are not separated per Arm/Group because the breakdown by individual treatment group within each arm results in numbers that are so small that the data becomes virtually useless. Patients enrolled in A1 who were treated at the maximum tolerated dose (MTD) and meet the eligibility requirement for A2 are also counted toward the A2 endpoints as per protocol. | Days | MEDIAN |
| SECONDARY | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | up to 3 months | It was planned that this outcome measure would be reported by Arm and not by individual dose levels within each arm. Pts enrolled in A1 who were treated at the max.tolerated dose and meet the eligibility requirement for A2 are also counted toward the A2 endpoints as per protocol. We are unable to calculate DCR at 4 mos because many pts with stable disease immediately went on to receive other therapies following completion of scheduled 2-3 cycles of LMB-100. Therefore,we are reporting DCR at EOT. | Proportion of participants | NUMBER |
| SECONDARY | Number of Participants With an Objective Response (OR) (Partial Responses + Complete Responses) in Phase 1 Arm A1 | Approximately 6 weeks after the start of treatment and continuing every 6 weeks until progression or start of a new treatment up to 1 year. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With an Objective Response (OR) (Partial Response + Complete Response) in Phase 1, Arm B | Approximately 6 weeks after the start of treatment and continuing every 6 weeks until progression or start of a new treatment up to 1 year. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Adverse Events Attributed to LMB-100 | Date treatment consent signed to date off study, approx. 11 mos, 8 days for A1DL1; 20 mos, 9 days for A1DL-1; 10 mos, 17 days for A2; 2 mos, 16 days for B1DL1; 14 mos, 30 days for B1DL2; 5 mos, 1 day for B2; and 4 mos, 15 days for B1DL3R. | No B2 grade 1, 3, and 4; B1 DL1 grade 1, 3, and 4; B1 DL2 grade 1; and B1 DL3R grade 1, 3, and 4 adverse events. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Date treatment consent signed to date off study, approx. 11 mos, 8 days for A1DL1; 20 mos, 9 days for A1DL-1; 10 mos, 17 days for A2; 2 mos, 16 days for B1DL1; 14 mos, 30 days for B1DL2; 5 mos, 1 day for B2; and 4 mos, 15 days for B1DL3R. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group789
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response (OR) (Partial Responses + Complete Responses) in Phase 2 Subjects of Short Infusion LMB-100+ Nab-paclitaxel | All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | 1 | Participants | ||
| Maximum Tolerated Dose (MTD) of Short Infusion LMB-100 + Nab Paclitaxel | All Participants in Arm A1, Dose Level-1, and Arm A1 Dose Level 1 Phase I Short Infusion | 65 | µg/kg | ||
| Maximum Tolerated Dose (MTD) of Continuous Infusion LMB-100 | All Participants in Arm B1 DL2 and Arm B1 DL 1 and Arm B1 DL3R Phase I 48-hr Continuous Infusion | 100 | Dose (µg/kg) | ||
| Progression Free Survival (PFS) | Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100 | NA | 95% Confidence Interval NA to NA | Months | |
| Progression Free Survival (PFS) | Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | NA | 95% Confidence Interval NA to NA | Months | |
| Progression Free Survival (PFS) | Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | NA | 95% Confidence Interval NA to NA | Months | |
| Progression Free Survival (PFS) | Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | NA | 95% Confidence Interval NA to NA | Months | |
| Progression Free Survival (PFS) | Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | NA | 95% Confidence Interval NA to NA | Months | |
| Progression Free Survival (PFS) | Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | NA | 95% Confidence Interval NA to NA | Months | |
| Progression Free Survival (PFS) | Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 789Source ClinicalTrials.gov
See all 789 results by groupParticipant flow84
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Arm A Dose Escalation | STARTED | Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100 | 6 | |
| Arm A Dose Escalation | STARTED | Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | 8 | |
| Arm A Dose Escalation | STARTED | Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | 0 | |
| Arm A Dose Escalation | STARTED | Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | 0 | |
| Arm A Dose Escalation | STARTED | Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | 0 | |
| Arm A Dose Escalation | STARTED | Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | 0 | |
| Arm A Dose Escalation | STARTED | Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | 0 | |
| Arm A Dose Escalation | COMPLETED | Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100 | 4 | |
| Arm A Dose Escalation | COMPLETED | Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | 7 | |
| Arm A Dose Escalation | COMPLETED | Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | 0 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 participant flowAdverse events399
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 | Platelet count decreased | Investigations | Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100 | 1 | 6 | 2 |
| other | Platelet count decreased | Investigations | Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | 4 | 8 | 4 |
| other | Platelet count decreased | Investigations | Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | 3 | 6 | 3 |
| other | Platelet count decreased | Investigations | Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in 10 | 2 | 6 | 3 |
| other | Platelet count decreased | Investigations | Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | 2 | 3 | 4 |
| other | Platelet count decreased | Investigations | Arm B1,Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | 2 | 6 | 3 |
| other | Platelet count decreased | Investigations | Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | 1 | 5 | 1 |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100 | 0 | 6 | 0 |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | 0 | 8 | 0 |
| other | Pleural effusion | Respiratory, thoracic and mediastinal disorders | Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | 1 | 6 | 2 |
1 to 10 of 399Source ClinicalTrials.gov
See all 399 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100 | 5 | 6 |
| Total, all-cause mortality | Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | 8 | 8 |
| Total, all-cause mortality | Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | 5 | 6 |
| Total, all-cause mortality | Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in 10 | 6 | 6 |
| Total, all-cause mortality | Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | 3 | 3 |
| Total, all-cause mortality | Arm B1,Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | 6 | 6 |
| Total, all-cause mortality | Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | 3 | 5 |
| Total, other adverse events | Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100 | 6 | 6 |
| Total, other adverse events | Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | 8 | 8 |
| Total, other adverse events | Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | 6 | 6 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36208017 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100 vs Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100: Number of Participants With an Objective Response (OR) (Partial Responses + Complete Responses) in Phase 1 Arm A1 |
Source 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/NCT02810418
GET https://conductscience.org/api/trials/v1/NCT02810418/registered?page=2