Trial Outcomes & Findings for Mesothelin-Targeted Immunotoxin LMB-100 in People With Malignant Mesothelioma (NCT NCT02798536)

Last Updated: 2022-08-23

Results Overview

Highest administered dose of LMB-100 + nab-paclitaxel at which no more than 1 of 6 participants experiences a dose limiting toxicity (DLT). A DLT is any of the following events attributed to LMB-100 and occurring within 21 days after the first dose of LMB-100 such as Grade 4 neutropenia, Grade 3 and 4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia associated with bleeding episodes. Grade ≥ 3 non-hematological toxicity with the exception of alopecia (any grade), Grade 3 nausea and vomiting without appropriate treatment, Grade 3 diarrhea lasting for ≤ 2 days with no fever or dehydration.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

21 participants

Primary outcome timeframe

3 weeks after initial dose

Results posted on

2022-08-23

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Level 1: 170mcg LMB-100 Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.	Dose Level -1: 140mcg LMB-100 Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
Overall Study STARTED	3	7	11
Overall Study COMPLETED	3	7	11
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mesothelin-Targeted Immunotoxin LMB-100 in People With Malignant Mesothelioma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1: 170mcg LMB-100 n=3 Participants Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.	Dose Level -1: 140mcg LMB-100 n=7 Participants Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=11 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	4 Participants n=4 Participants	10 Participants n=27 Participants	15 Participants n=483 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	6 Participants n=483 Participants
Age, Continuous	58.77 years STANDARD_DEVIATION 19.07 • n=93 Participants	57.09 years STANDARD_DEVIATION 11.84 • n=4 Participants	52.45 years STANDARD_DEVIATION 16.46 • n=27 Participants	54.9 years STANDARD_DEVIATION 14.87 • n=483 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	5 Participants n=4 Participants	6 Participants n=27 Participants	12 Participants n=483 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants	9 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=93 Participants	7 Participants n=4 Participants	10 Participants n=27 Participants	20 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants	6 Participants n=4 Participants	8 Participants n=27 Participants	17 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Region of Enrollment United States	3 participants n=93 Participants	7 participants n=4 Participants	11 participants n=27 Participants	21 participants n=483 Participants

PRIMARY outcome

Timeframe: 3 weeks after initial dose

Population: Number of participants in the recommended Phase 2 (RP2D) of LMB-100 and the recommended Phase 2 Dose (RP2D) of LMB100 + Nab-paclitaxel are noted below.

Outcome measures

Outcome measures
Measure	All Participants n=21 Participants Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
Recommended Phase 2 Dose (RP2D) of LMB100 + Nab-paclitaxel Recommended Phase 2 (RP2D) of LMB-100	140 mcg	—	—
Recommended Phase 2 Dose (RP2D) of LMB100 + Nab-paclitaxel Recommended Phase 2 Dose (RP2D) of LMB100 + Nab-paclitaxel	100 mcg	—	—

SECONDARY outcome

Timeframe: End of treatment, an average of 57.6 days

Number of participants at maximum tolerated dose (MTD) with partial or complete response measured by the Response Evaluation Criteria in Solid Tumors (RECIST). 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. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Outcome measures

Outcome measures
Measure	All Participants n=7 Participants Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=11 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
Number of Participants at Recommended Phase 2 Dose (RP2D) With Partial or Complete Response by the Response Evaluation Criteria in Solid Tumors (RECIST) Complete Response	0 Participants	0 Participants	—
Number of Participants at Recommended Phase 2 Dose (RP2D) With Partial or Complete Response by the Response Evaluation Criteria in Solid Tumors (RECIST) Partial Response	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: At progression, up to 3.6 months

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was measured 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. The appearance of one or more new lesions is also considered progressions.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=7 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=11 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
Median Progression Free Survival (PFS)	2.7 months Interval 2.7 to 3.0	2.7 months Interval 1.5 to 3.2	2.7 months Interval 1.3 to 3.6

SECONDARY outcome

Timeframe: At death, up to 60.8 months

OS is defined as the duration of time from start of treatment to time of death.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=7 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=11 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
Median Overall Survival (OS)	33.5 months Interval 27.7 to 34.6	16.9 months Interval 6.8 to 60.8	10.1 months Interval 3.7 to 30.9

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 2 (each cycle is 21 days), approximately 42 days

Number of participants with LMB-100 Maximum observed serum concentration (Cmax) of \>100ng/mL was measured by

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=7 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=11 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
Number of Participants With LMB-100 Maximum Observed Serum Concentration (Cmax) of >100ng/mL Cycle 1	3 Participants	7 Participants	10 Participants
Number of Participants With LMB-100 Maximum Observed Serum Concentration (Cmax) of >100ng/mL Cycle 2	2 Participants	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Cycle 1 and Cycle 2 (each cycle is 21 days), approximately 42 days

ADAs formation to LMB-100 were measured by the enzyme-linked immunosorbent assay (ELISA). The presence of ADAs (i.e., positive) may indicate the participant may have poor blood levels.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=7 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=10 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
Number of Participants With Anti-drug Antibodies (ADAs) Formation to LMB-100 No ADA formation	0 Participants	0 Participants	2 Participants
Number of Participants With Anti-drug Antibodies (ADAs) Formation to LMB-100 Cycle 1	0 Participants	2 Participants	3 Participants
Number of Participants With Anti-drug Antibodies (ADAs) Formation to LMB-100 Cycle 2	3 Participants	5 Participants	5 Participants

SECONDARY outcome

Timeframe: 30 days after treatment

Adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 3 is serious, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=7 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=11 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
Number of Grade 3-5 Adverse Events Possibly, Probably, and/or Definitely Related to the LMB-100 +/- Nab-Paclitaxel Grade 3 hyponatremia possibly related	0 adverse events	0 adverse events	1 adverse events
Number of Grade 3-5 Adverse Events Possibly, Probably, and/or Definitely Related to the LMB-100 +/- Nab-Paclitaxel Grade 3 edema limbs possibly related	0 adverse events	0 adverse events	1 adverse events
Number of Grade 3-5 Adverse Events Possibly, Probably, and/or Definitely Related to the LMB-100 +/- Nab-Paclitaxel Grade 3 hypotension probably related	0 adverse events	0 adverse events	1 adverse events
Number of Grade 3-5 Adverse Events Possibly, Probably, and/or Definitely Related to the LMB-100 +/- Nab-Paclitaxel Grade 3 atrial fibrillation probably related	0 adverse events	0 adverse events	1 adverse events
Number of Grade 3-5 Adverse Events Possibly, Probably, and/or Definitely Related to the LMB-100 +/- Nab-Paclitaxel Grade 3 hypoalbuminemia definitely related	0 adverse events	0 adverse events	4 adverse events
Number of Grade 3-5 Adverse Events Possibly, Probably, and/or Definitely Related to the LMB-100 +/- Nab-Paclitaxel Grade 3 hyponatremia definitely related	0 adverse events	2 adverse events	0 adverse events
Number of Grade 3-5 Adverse Events Possibly, Probably, and/or Definitely Related to the LMB-100 +/- Nab-Paclitaxel Grade 4 CPK increased probably related	0 adverse events	0 adverse events	1 adverse events
Number of Grade 3-5 Adverse Events Possibly, Probably, and/or Definitely Related to the LMB-100 +/- Nab-Paclitaxel Grade 3 CPK increased probably related	0 adverse events	0 adverse events	1 adverse events

SECONDARY outcome

Timeframe: time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented by computed tomography (CT) scans performed every 6 weeks.

The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Progressive disease was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=7 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=11 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
Duration of Response (DOR)	NA months Criteria not met for CR or PR so DOR not calculated, data is not available.	NA months Criteria not met for CR or PR so DOR not calculated, data is not available.	NA months Criteria not met for CR or PR so DOR not calculated, data is not available.

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.

Here is the number of participants with serious and/or 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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=7 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=11 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).	3 Participants	7 Participants	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: First 21 days after first dose of LMB-100

A DLT is any of the following events attributed to LMB-100 and occurring within 21 days after the first dose of LMB-100 such as Grade 4 neutropenia, Grade 3 and 4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia associated with bleeding episodes. Grade ≥ 3 non-hematological toxicity with the exception of alopecia (any grade), Grade 3 nausea and vomiting without appropriate treatment, Grade 3 diarrhea lasting for ≤ 2 days with no fever or dehydration.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles. Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=7 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=11 Participants Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
Number of Participants With Dose-limiting Toxicities (DLT)	0 Participants	0 Participants	1 Participants

Adverse Events

Dose Level 1: 170mcg LMB-100

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Dose Level -1: 140mcg LMB-100

Serious events: 0 serious events

Other events: 7 other events

Deaths: 6 deaths

Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel

Serious events: 4 serious events

Other events: 11 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Dose Level 1: 170mcg LMB-100 n=3 participants at risk Dose Level 1: 170mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.	Dose Level -1: 140mcg LMB-100 n=7 participants at risk Dose Level -1: 140mcg LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles.	Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel n=11 participants at risk Dose Level -2: 100mcg LMB-100 + Nab-Paclitaxel given intravenously. LMB-100 given intravenously on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles. Nab-Paclitaxel given intravenously on days 1 and 8 of each 21 day cycle for up to 6 cycles.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, Death	0.00% 0/3 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.
Vascular disorders Thromboembolic event	33.3% 1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	9.1% 1/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.
Investigations Creatine phosphokinase (CPK) increased	0.00% 0/3 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.
General disorders Fatigue	0.00% 0/3 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.
Vascular disorders Hypotension	0.00% 0/3 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/3 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	9.1% 1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.
Gastrointestinal disorders Nausea	0.00% 0/3 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	9.1% 1/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	0.00% 0/7 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.	9.1% 1/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 34 months and 19 days for Dose Level 1, 52 months for Dose Level -1, and 42 months and 3 days for Dose Level -2.

Other adverse events

Additional Information

Dr. Raffit Hassan

National Cancer Institute

Phone: 240-760-6232

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place