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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

A Phase Ib/II Study of Mesothelin-Targeted Immunotoxin LMB-100 Alone or in Combination With Nab-Paclitaxel in Participants With Previously Treated Metastatic and/ or Locally Advanced Pancreatic Ductal Adenocarcinoma and Mesothelin Expressing Solid Tumors

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02810418
Enrollment
40
Registered
2016-06-23
Start date
2016-08-03
Completion date
2021-06-22
Last updated
2022-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Pancreatic Neoplasms

Keywords

Immunotoxin, Mesothelin, Antibody-based Therapeutics, Advanced Cancer

Brief summary

Background: LMB-100 is a man-made protein designed to kill cancer cells. LMB-100 targets a cancer marker called mesothelin. Mesothelin is found on the surface of many different tumors, including pancreatic cancer, but is made by a very small number of normal tissues. Other cancers that make mesothelin include mesothelioma, cholangiocarcinoma, thymic carcinoma, ovarian, lung, gastric, endometrial, cervical, and ampullary cancers. After binding to the mesothelin on tumors, LMB-100 can attack and kill cancer cells. Researchers want to see how well it works when given with and without nab-paclitaxel, a drug which treats pancreatic cancer. Objectives: Arm A- To find a safe dose of LMB-100 with a fixed standard dose of nab-paclitaxel in people with advanced pancreatic cancer. To see how well the combination of the two drugs reduce tumor size. Arm B- To find a safe dose of LMB-100 when it is given as a continuous infusion over several days. Eligibility: Arm A- Adults age 18 and older with advanced pancreatic cancer that has worsened after anti-cancer therapy. Arm B- Adults age 18 and older with advanced pancreatic cancer, mesothelioma or other solid tumor that makes mesothelin that has worsened after anti-cancer therapy Design: Participants will be screened with medical history and physical exam. They will give blood, urine, and tissue samples. They will have scans and x-rays. During each 21-day cycle: * For Arm A * Participants will get LMB-100 by an intravenous (IV) catheter on days 1, 3, and 5. This is a tube inserted in a vein, usually in the arm. * Participants will get nab-paclitaxel by IV on days 1 and 8. * For Arm B * Participants will get LMB-100 by an IV catheter as a continuous infusion beginning on day 1 and continuing for 2-4 days * Some participants will also get nab-paclitaxel by IV on days 1 and 8. All participants will get this combination for up to 2 cycles or until their disease worsens or they have intolerable side effects. Participants will have blood and urine tests and scans throughout the study. Participants will have a safety follow-up visit 3-6 weeks after treatment ends. If their disease remains stable or improves, they will be scanned every 6 weeks until their disease gets worse. Even if their disease gets worse, they or their doctor will be called to talk about their cancer status....

Detailed description

Background: * Pancreatic cancer is the fourth most common cause of cancer death in the United States, claiming more than 40,000 lives each year. * Incidence nearly equals mortality with just 6% of participants living five years beyond their diagnosis. Most patients are diagnosed at an advanced stage, but even patients with early stage disease have a long term survival of less than 20%. * Mesothelin is specifically a marker of adenocarcinoma in the human disease and is not expressed in preceding pre-malignant stages of tumor development * Expression of mesothelin in pancreatic ductal adenocarcinoma (PDA) has been examined in several published studies and ranges from 86 to 100% * Recombinant immunotoxins (RITs) are antibody-based therapeutics that carry a toxin payload. RITs that target mesothelin contain a genetically engineered variant of Pseudomonas exotoxin A (PE) in which the native cell-binding domain of PE is replaced by the mesothelin-binding antibody fragment. SS1P was the first mesothelin-targeted RIT tested in patients. * LMB-100 contains a newly engineered PE fragment that has improved activity against most pancreatic cancer cell lines in vitro, and is also much less toxic than SS1P in preclinical models. The new PE contains modifications specifically designed to reduce immunogenicity of the molecule. * Pre-administration of paclitaxel with SS1P was demonstrated to increase the amount of immunotoxin internalized by tumor cells and to reduce levels of shed mesothelin in the intra-tumoral environment so that more immunotoxin could bind tumor cells. The effect is even more pronounced with NAB-paclitaxel in a pancreatic cancer model. * Initial clinical testing of LMB-100 was performed by Roche in a multi-center international first in human trial (NCT02317419). The agent was well tolerated and appeared to have decreased immunogenicity compared to SS1P based on preliminary results. * In initial and subsequent clinical testing, LMB-100 was found to have half-life of approximately 60 mins. This is shorter then that measured for previous RITs used in the clinical setting. Primary Objectives: * Arm A1 (Phase I, short infusion): --To determine the maximum tolerated dose of short infusion LMB-100 in combination nab-paclitaxel chemotherapy in participants with advanced pancreatic cancer * Arm B1(Continuous infusion single agent lead-in): --To determine the maximum tolerated dose of LMB-100 given in a continuous infusion format over 24 - 96 hours to patients with advanced solid tumors that express mesothelin * Arm B2 (Continuous infusion combination therapy) --Establish a tolerated dose of LMB-100 given by continuous infusion in combination with nab-paclitaxel chemotherapy in participants with advanced pancreatic cancer * Arm A2 (Phase II, short infusion): * To determine the objective response rate (Partial Response (PR)+Complete Response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria of short infusion LMB-100 in combination with nab-paclitaxel chemotherapy in participants with advanced pancreatic cancer Eligibility: * Age greater than or equal to18 years * Histologically confirmed recurrent, metastatic and/or advanced pancreatic ductal adenocarcinoma (Except for Arm B1 \[B Single Agent Lead-in\]) * For Arm B1 (Single Agent Lead-in), ONLY: Histologically confirmed solid tumor malignancy for which no curative therapy exists with at least 25% of tumor cells expressing mesothelin as determined by National Cancer Institute (NCI) Laboratory of Pathology. Determination can be made using archival tumor tissue or fresh biopsy. * Treatment must include at least one prior chemotherapy regimen * No nab-paclitaxel or paclitaxel treatment in the last four months (Except for Arm B1 \[Single Agent Lead-in\]) * Adequate organ function * Participants with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections are eligible only for the Arm B1 (Single Agent Lead-in) Design: * This study is a Phase I/II open label study to assess the safety and efficacy of LMB-100 in combination with the standard of care agent nab-paclitaxel in participants metastatic and/or locally advanced pancreatic ductal adenocarcinoma * Subjects will be treated for up to 2 cycles * In Arm A1 (Phase I, short infusion) of the study, up to 3 dose levels will be evaluated. LMB-100 will be administered on days 1, 3 and 5 of a 21 day cycle and nab-paclitaxel will be administered on days 1 and 8 * Arm A2 (Phase II, short infusion), up to 20 evaluable participants (including those treated at the short infusion maximum tolerated dose (MTD) in the phase I study) will be enrolled. * Arm B1 (Continuous infusion single Agent Lead-in), escalating doses of single agent LMB-100 will be administered. The study drug will be given as a continuous infusion for the 1, 2, 3, or 4 days of a 21-day cycle. * Arm B2 (Continuous infusion, combination therapy) will be initiated after completion of both Arm A1 and Arm B1 Single Agent Lead-in. It will test a single dose level of LMB-100 based on data from the Lead-in given in combination with nab-paclitaxel. LMB-100 will be given as a continuous infusion for the 1, 2, 3 or 4 days of a 21-day cycle. Nabpaclitaxel will be given on Day 1 and Day 8. * The Arm A2 (Phase II, short infusion) portion of the study will be conducted in a Simon Minimax two stage phase II design. The first stage will enroll 13 evaluable participants, including the six participants treated at the short infusion MTD from phase I. If 1 or more has a response, then accrual would continue until a total of 20 evaluable participants have been enrolled.

Interventions

Arms A1 and A2 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles Arm B1 (continuous infusion): Administered IV for 24, 48, 72 or 96 hours continuously on the first 1 - 4 days or 24 hour infusions on days 1 and 4 (depending on dose level) of each 21 day cycle for a maximum of 2 cycles. Arm B2 (continuous infusion): Administered IV for 24,48, 72 or 96 hours continuously on the first 1 - 4 days or 24 hour infusions on days 1 and 4 (depending on dose level) of each 14 day cycle for a maximum of 3 cycles.

DRUGNab-Paclitaxel

Administered intravenously (IV) on days 1 and for Arms A1, A2 and B1 on day 8 of each 14-21 day cycle for a maximum of 2 (Arms A1, A2 and B1) or 3 (Arm B2) cycles

Research blood test for Arm B1 eligibility

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* INCLUSION CRITERIA: * For participants who will be receiving nab-paclitaxel (all arms except Phase I Arm B Single Agent Lead-in) * Histologically confirmed recurrent, advanced or metastatic pancreatic ductal adenocarcinoma as determined by National Cancer Institute (NCI) Laboratory of Pathology. * No treatment with paclitaxel or nab-paclitaxel within 4 months prior to initiation of study therapy * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. * Adequate hematological function: neutrophil count of greater than or equal to 1.0 x 10(9) cells/L, platelet count of greater than or equal to 95,000/microliters, hemoglobin greater than or equal to 9 g/dL * Measurable disease as per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria v 1.1 * For participants who will NOT receive nab-paclitaxel (Arm B1 Single Agent Lead-in only) * Histologically confirmed solid tumor malignancy for which no curative therapy exists with at least 25% of tumor cells expressing mesothelin as determined by NCI Laboratory of Pathology. Determination can be made using archival tumor tissue or fresh biopsy. Subjects with epithelioid mesothelioma and pancreatic adenocarcinoma are automatically eligible and are not required to have this test. * ECOG performance status (PS) 0-2. * Adequate hematological function: neutrophil count of greater than or equal to 1.0 x 10(9) cells/L, platelet count of greater than or equal to 85,000/microliters, hemoglobin greater than or equal to 8.5 g/dL * Measurable and/or evaluable disease as per the RECIST Criteria v 1.1 * For all arms of the protocol * Participants must have received at least one prior chemotherapy regimen for their disease. * Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of LMB-100 in combination with nab-paclitaxel in persons \<18 years of age, children are excluded from this study. * Participants must be more than 14 days removed from most recent minor surgical procedure (such as biliary stenting), 28 days from most recent major surgical procedure, 14 days removed from most recent radiation therapy, chemotherapy or experimental drug treatment with published half-life known to be 72 hours or less and 28 days removed from last experimental drug treatment with unpublished or half-life greater than 72 hours. * All acute toxic effects of any prior radiotherapy, chemotherapy, experimental drug treatment or surgical procedure must have resolved to Grade less than or equal to 1, except alopecia (any grade) and peripheral neuropathy. * Serum albumin greater than or equal to 2.5 mg/dL without intravenous supplementation * Adequate liver function: Bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 x upper limit of normal (ULN). AST and ALT up to 5x ULN is permitted for patients with liver metastases. * Adequate renal function: creatinine clearance greater than or equal to 50 mL/min. * Must have left ventricular ejection fraction \> 50% * Must have an ambulatory oxygen saturation of \> 88% on room air * The effects of LMB-100 alone or in combination with nab-paclitaxel on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry until 3 months the last dose of study therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Ability of participant to understand and the willingness to sign a written informed consent document.

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Objective Response (OR) (Partial Responses + Complete Responses) in Phase 2 Subjects of Short Infusion LMB-100+ Nab-paclitaxelApproximately 6 weeks after the start of treatment and continuing every 6 weeks until progression or start of a new treatment, up to 1 yearOR 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
Maximum Tolerated Dose (MTD) of Short Infusion LMB-100 + Nab Paclitaxel21 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.
Maximum Tolerated Dose (MTD) of Continuous Infusion LMB-10021 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

MeasureTime frameDescription
Number of Participants With an Objective Response (OR) (Partial Responses + Complete Responses) in Phase 1 Arm A1Approximately 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
Number of Participants With an Objective Response (OR) (Partial Response + Complete Response) in Phase 1, Arm BApproximately 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.
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.
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.
Number of Participants With Adverse Events Attributed to LMB-100Date 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.
Overall Survival (OS)Time from treatment initiation to death, up to 1-2 years.OS is the average time from treatment initiation to death.
Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)up to 3 monthsDCR 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.

Other

MeasureTime frameDescription
Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm A1 and Arm A2For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day 1. Pre-dose and end of infusion (EOI) during Cycle 2 Day 1.The maximum observed analyte concentration of dose was reported.
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)First 28 days following infusion of LMB-100 on Cycle 1, Day 1 through the duration of the study treatment up to 1 year.A DLT is defined per protocol as events attributed to LMB-100 and occurring during the DLT period such as hematological toxicities: Grade 4 neutropenia, Grade 3 and 4 febrile neutropenia, Grade 4 thrombocytopenia, and Grade 3 thrombocytopenia associated with bleeding episodes. Grade ≥3 non-hematological toxicity with the exception of: Grade 3 nausea and vomiting without appropriate treatment, Grade 3 diarrhea lasting ≤2 days with no fever or dehydration, and isolated Grade 3 fever. Grade ≥4 non-hematological toxicity: infusion related reactions, and any other drug related toxicity qualified as a DLT per the discretion of the principal investigator.
Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2For Arms B1 & B2: Pre-dose, end of loading dose, 2 and 6 hours after start of continuous infusion, end of infusion (EOI) and 2 hrs after EOI during Cycle 1 Day 1. Pre-dose, end of loading dose and EOI during Cycle 2 Day 1.The maximum observed analyte concentration in serum was reported.
Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUCinf)For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day 1.Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0). It is used to characterize drug absorption.
Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf)/D (Dose)For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day 1.The AUC is a measure of the serum concentration of the drug dose over time. It is used to characterize drug absorption.
Area Under the Serum Concentration Versus Time Curve Extrapolated to Last Measurement (AUClast)/DFor Arms B1 & B2: Pre-dose, end of loading dose, 2 and 6 hours after start of continuous infusion, end of infusion (EOI) and 2 hrs after EOI during Cycle 1 Day 1.The AUC is a measure of the serum concentration of the drug dose over time. It is used to characterize drug absorption
Time Curve Extrapolated to Last Measurement (AUClast) for LMB-100For Arms B1 & B2: Pre-dose, end of loading dose, 2 and 6 hours after start of continuous infusion, end of infusion (EOI) and 2 hrs after EOI during Cycle 1.Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated to last measurement. It is used to characterize drug absorption.
The Total Clearance (CL) of LMB-100For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day 1.The CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Plasma Half-Life (T1/2) of LMB-100For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1, Day 1.Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.
Volume of Distribution (Vd) of LMB-100For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1, Day 1.Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm A1 and Arm A2For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day. Pre-dose and end of infusion (EOI) during Cycle 2 Day 1.The maximum observed analyte concentration in serum was reported.
Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2For Arms B1 & B2: Pre-dose, end of loading dose, 2 and 6 hours after start of continuous infusion, end of infusion (EOI) and 2 hrs after EOI during Cycle 1 Day 1. Pre-dose, end of loading dose and EOI during Cycle 2 Day 1.The maximum observed analyte concentration in serum was reported.

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100
Arm A1, DL1, Ph I Short Infusion 100µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
6
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
8
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
6
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
6
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
3
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
6
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
5
Total40

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006
Arm A Dose EscalationAdverse Event2100000
Arm B Dose EscalationAdverse Event0000120
Dose ExpansionAdverse Event0110000
Dose ExpansionPhysician Decision0020000

Baseline characteristics

CharacteristicTotalArm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inArm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inArm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inArm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
15 Participants0 Participants3 Participants4 Participants2 Participants0 Participants3 Participants3 Participants
Age, Categorical
Between 18 and 65 years
25 Participants6 Participants5 Participants2 Participants4 Participants3 Participants3 Participants2 Participants
Age, Continuous61.0 years
STANDARD_DEVIATION 10.6
54.5 years
STANDARD_DEVIATION 7.6
61.0 years
STANDARD_DEVIATION 7.7
69.9 years
STANDARD_DEVIATION 8.5
47.0 years
STANDARD_DEVIATION 12.5
59.2 years
STANDARD_DEVIATION 12.3
62.8 years
STANDARD_DEVIATION 7.9
66.8 years
STANDARD_DEVIATION 10.4
Baseline CA 19-9
Patient 1
404.7 Unit/mL404.7 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 10
10106 Unit/mL0 Unit/mL10106 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 11
13.2 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL13.2 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 12
25180 Unit/mL0 Unit/mL25180 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 13
14.8 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL14.8 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 14
911.3 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL911.3 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 15
88.4 Unit/mL0 Unit/mL88.4 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 16
284.7 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL284.7 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 17
302.6 Unit/mL0 Unit/mL302.6 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 18
4206 Unit/mL0 Unit/mL4206 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 19
93.7 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL93.7 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 2
10650 Unit/mL10650 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 20
4482 Unit/mL0 Unit/mL4482 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 21
142.9 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL142.9 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 22
446.6 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL446.6 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 23
389.5 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL389.5 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 24
156.8 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL156.8 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 25
13348 Unit/mL0 Unit/mL13348 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 26
9254 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL9254 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 27
138.3 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL138.3 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 28
0.6 Unit/mL0 Unit/mL0.6 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 29
9571 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL9571 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 3
248800 Unit/mL248800 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 30
2077 Unit/mL0 Unit/mL0 Unit/mL2077 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 31
3424 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL3424 Unit/mL
Baseline CA 19-9
Patient 32
9326 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL9326 Unit/mL
Baseline CA 19-9
Patient 33
760 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL760 Unit/mL
Baseline CA 19-9
Patient 34
3297 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL3297 Unit/mL
Baseline CA 19-9
Patient 35
6345 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL6345 Unit/mL
Baseline CA 19-9
Patient 36
2966 Unit/mL0 Unit/mL0 Unit/mL2966 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 37
99.8 Unit/mL0 Unit/mL0 Unit/mL99.8 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 38
1340 Unit/mL0 Unit/mL0 Unit/mL1340 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 39
31440 Unit/mL0 Unit/mL0 Unit/mL31440 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 4
27.8 Unit/mL27.8 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 40
3857 Unit/mL0 Unit/mL0 Unit/mL3857 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 5
7081 Unit/mL7081 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 6
123 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL123 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 7
1277 Unit/mL1277 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 8
94210 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL94210 Unit/mL0 Unit/mL0 Unit/mL
Baseline CA 19-9
Patient 9
1500 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL0 Unit/mL1500 Unit/mL0 Unit/mL0 Unit/mL
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
36 Participants6 Participants8 Participants5 Participants6 Participants3 Participants6 Participants2 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants3 Participants
Number of Participants with Prior Therapies
Prior nab-paclitaxel
20 Participants1 Participants3 Participants2 Participants5 Participants1 Participants5 Participants3 Participants
Number of Participants with Prior Therapies
Radiation
26 Participants5 Participants4 Participants5 Participants4 Participants2 Participants2 Participants4 Participants
Number of Participants with Prior Therapies
Whipple
20 Participants2 Participants5 Participants4 Participants2 Participants1 Participants3 Participants3 Participants
Number of Participants with Sites of Disease
Ascites
8 Participants1 Participants0 Participants2 Participants2 Participants1 Participants2 Participants0 Participants
Number of Participants with Sites of Disease
Liver
24 Participants4 Participants5 Participants4 Participants3 Participants3 Participants4 Participants1 Participants
Number of Participants with Sites of Disease
Lung
23 Participants2 Participants5 Participants4 Participants3 Participants3 Participants3 Participants3 Participants
Number of Participants with Sites of Disease
Other
25 Participants2 Participants3 Participants6 Participants5 Participants3 Participants3 Participants3 Participants
Participants Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
0
14 Participants2 Participants4 Participants3 Participants2 Participants0 Participants1 Participants2 Participants
Participants Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
1
24 Participants4 Participants4 Participants3 Participants4 Participants1 Participants5 Participants3 Participants
Participants Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
2
1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants
Participants Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Unknown
1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
3 Participants0 Participants1 Participants0 Participants1 Participants0 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
4 Participants0 Participants0 Participants0 Participants1 Participants2 Participants1 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
White
32 Participants6 Participants7 Participants6 Participants4 Participants1 Participants4 Participants4 Participants
Region of Enrollment
United States
40 participants6 participants8 participants6 participants6 participants3 participants6 participants5 participants
Sex: Female, Male
Female
18 Participants2 Participants4 Participants4 Participants2 Participants2 Participants1 Participants3 Participants
Sex: Female, Male
Male
22 Participants4 Participants4 Participants2 Participants4 Participants1 Participants5 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
deaths
Total, all-cause mortality
5 / 68 / 85 / 66 / 63 / 36 / 63 / 5
other
Total, other adverse events
6 / 68 / 86 / 66 / 63 / 36 / 65 / 5
serious
Total, serious adverse events
3 / 64 / 81 / 62 / 62 / 32 / 61 / 5

Outcome results

Primary

Maximum Tolerated Dose (MTD) of Continuous Infusion LMB-100

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

Time frame: 21 days after LMB-100 is administered (end of cycle 1)

Population: 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.

ArmMeasureValue (NUMBER)
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Maximum Tolerated Dose (MTD) of Continuous Infusion LMB-100100 Dose (µg/kg)
Primary

Maximum Tolerated Dose (MTD) of Short Infusion LMB-100 + Nab Paclitaxel

MTD is defined as the highest dose tolerated without exceeding a pre-set number of adverse events in Phase 1, Arm A.

Time frame: 21 days after LMB-100 is administered (end of cycle 1)

ArmMeasureValue (NUMBER)
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Maximum Tolerated Dose (MTD) of Short Infusion LMB-100 + Nab Paclitaxel65 µg/kg
Primary

Objective Response (OR) (Partial Responses + Complete Responses) in Phase 2 Subjects of Short Infusion LMB-100+ Nab-paclitaxel

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

Time frame: 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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Objective Response (OR) (Partial Responses + Complete Responses) in Phase 2 Subjects of Short Infusion LMB-100+ Nab-paclitaxel1 Participants
Secondary

Number of Participants With Adverse Events Attributed to LMB-100

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.

Time frame: 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.

Population: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Weight gain2 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Generalized pain0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100GI disturbances2 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypocalcemia1 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia4 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Anemia0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting2 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Myalgia4 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased1 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Proteinuria0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Dizziness2 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Dyspnea0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Edema2 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances1 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Elevated LFT's1 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hyponatremia4 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Anorexia2 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypotension3 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Rash and pruritis1 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Fatigue2 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Fever1 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Tachycardia2 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Fatigue3 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Tachycardia0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Dyspnea0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Generalized pain0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions2 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100GI disturbances0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypocalcemia0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypotension0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Weight gain1 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Edema1 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia6 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hyponatremia0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Anemia3 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Myalgia1 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Allergic reaction1 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Elevated LFT's0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Proteinuria0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Fever1 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Proteinuria0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypotension1 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hyponatremia2 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Tachycardia0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100GI disturbances0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Generalized pain0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Weight gain1 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Fever0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Fatigue1 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypocalcemia0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Elevated LFT's0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Myalgia2 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Edema0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Dyspnea0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Anemia1 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Tachycardia1 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Myalgia0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting4 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Generalized pain1 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Proteinuria0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Ascites1 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypocalcemia1 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Dizziness1 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia7 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Dyspnea2 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Rash and pruritis2 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100GI disturbances6 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hyponatremia2 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Elevated LFT's2 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Anemia0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypotension1 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Weight gain4 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Fatigue4 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Anorexia1 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Pleuritic pain1 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances5 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Chills1 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Fever3 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Edema6 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Weight gain1 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hyponatremia0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Fatigue0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia4 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Generalized pain1 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Elevated LFT's0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypotension1 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances6 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Chills1 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Edema2 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypoxia1 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Dyspnea0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions1 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Proteinuria2 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Dehydration1 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Myalgia0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Pleuritic pain1 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Anemia0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100GI disturbances1 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia7 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Creatinine increased1 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Tachycardia1 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Fever2 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypocalcemia0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia2 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Generalized pain0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Decreased urine output1 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Tachycardia0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Myalgia0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Fatigue0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hyponatremia1 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Cough1 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100GI disturbances0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Fever0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Dyspnea0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Anemia0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Acute kidney injury1 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Proteinuria0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypocalcemia0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Weight gain0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Edema1 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Elevated LFT's0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Hypotension0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100GI disturbances0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Proteinuria0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Tachycardia0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Weight gain0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Anemia0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Dyspnea0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Edema0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Elevated LFT's0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Fatigue0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Fever0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Generalized pain0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Hypocalcemia0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Hyponatremia0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Hypotension0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Myalgia0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting0 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Tachycardia0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Myalgia0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pleural effusion1 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Elevated LFT's0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypocalcemia0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hyponatremia0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dyspnea0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Fever0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Weight gain1 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Anemia0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypotension1 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Generalized pain1 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Proteinuria0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100GI disturbances0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pericardial effusion1 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pulmonary edema1 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Fatigue0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Edema3 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia4 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
Arm A2, Phase 2 Grade 2Number of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Weight gain3 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Ascites1 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Hypotension0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Myalgia3 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100GI disturbances2 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting1 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Elevated LFT's2 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Tachycardia0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia6 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Dyspnea1 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances2 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Hyponatremia2 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Hypocalcemia1 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Proteinuria0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Fever0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Edema4 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction1 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Fatigue1 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Anemia0 Participants
Arm A2, Phase 2 Grade 1Number of Participants With Adverse Events Attributed to LMB-100Generalized pain1 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Hypocalcemia0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia1 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Fever0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Elevated LFT's0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Weight gain0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Fatigue0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Myalgia0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Anemia0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Pulmonary edema1 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Hypotension1 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Hyponatremia1 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Proteinuria0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Pleural effusion1 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Dyspnea0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Tachycardia0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Edema0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100GI disturbances0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction1 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances1 Participants
Arm A2, Phase 2 Grade 3Number of Participants With Adverse Events Attributed to LMB-100Generalized pain0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Generalized pain0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Hypotension1 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Fever0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Edema0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Tachycardia0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100GI disturbances0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Fatigue0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation1 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Weight gain0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Proteinuria0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Anemia0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Elevated LFT's0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Hyponatremia0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Myalgia0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Dyspnea0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction1 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Hypocalcemia0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm A2, Phase 2 Grade 4Number of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Anemia1 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting1 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dyspnea0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Edema4 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hyponatremia0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypocalcemia1 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Elevated LFT's1 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Weight gain2 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Fatigue0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Fever1 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Generalized pain0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100GI disturbances1 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Tachycardia0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia3 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypotension3 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Proteinuria2 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Myalgia0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
Arm B1, Dose Level 2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Elevated LFT's1 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Fever0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Generalized pain0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100GI disturbances0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Tachycardia0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Edema0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Dyspnea0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Hypocalcemia0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Hyponatremia0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Hypotension0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Proteinuria1 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Anemia0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Myalgia0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Weight gain0 Participants
Arm B1, Dose Level 2 Phase I Grade 3Number of Participants With Adverse Events Attributed to LMB-100Fatigue0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Hyponatremia0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Hypotension0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Edema0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Generalized pain0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Tachycardia0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Fever0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Dyspnea0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased1 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Hypocalcemia0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Myalgia0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100GI disturbances0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Fatigue0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Elevated LFT's0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Proteinuria0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Anemia0 Participants
Arm B1, Dose Level 2 Phase I Grade 4Number of Participants With Adverse Events Attributed to LMB-100Weight gain0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100GI disturbances0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Tachycardia0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Myalgia0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia2 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dyspnea0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypocalcemia0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hyponatremia0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypotension0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Weight gain0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Proteinuria0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Fatigue1 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Fever0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Elevated LFT's0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Generalized pain0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Edema0 Participants
Arm B1, Dose Level 1 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Anemia0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Anemia0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Weight gain0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Generalized pain0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Fatigue0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypocalcemia0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Myalgia0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Tachycardia0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia4 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100GI disturbances0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Fever1 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dyspnea1 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Elevated LFT's0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Edema0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypotension0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Proteinuria0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
Arm B1, Dose Level 3R Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hyponatremia0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Tachycardia1 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100GI disturbances0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Decreased urine output0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dehydration0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Ascites0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dizziness0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypoalbuminemia2 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pericardial effusion0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypoxia0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Rash and pruritis0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypotension2 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Proteinuria1 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Fever1 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Generalized pain0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Edema0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Creatinine increased0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Acute kidney injury0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Atrial fibrillation0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pleural effusion0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Elevated LFT's0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Lymphocyte count decreased0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Chills0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Infusion-related reactions0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pleuritic pain0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Anemia1 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Ventricular dysfunction0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypocalcemia0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Anorexia0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hypophosphatemia1 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Pulmonary edema0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Nausea and vomiting0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Fatigue2 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Allergic reaction0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Cough0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Myalgia0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Weight gain0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Electrolyte disturbances0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Hyponatremia0 Participants
Arm B2 Phase I Grade 2Number of Participants With Adverse Events Attributed to LMB-100Dyspnea0 Participants
Secondary

Number of Participants With an Objective Response (OR) (Partial Response + Complete Response) in Phase 1, Arm B

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With an Objective Response (OR) (Partial Response + Complete Response) in Phase 1, Arm B0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With an Objective Response (OR) (Partial Response + Complete Response) in Phase 1, Arm B0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With an Objective Response (OR) (Partial Response + Complete Response) in Phase 1, Arm B0 Participants
Secondary

Number of Participants With an Objective Response (OR) (Partial Responses + Complete Responses) in Phase 1 Arm A1

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

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With an Objective Response (OR) (Partial Responses + Complete Responses) in Phase 1 Arm A10 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With an Objective Response (OR) (Partial Responses + Complete Responses) in Phase 1 Arm A11 Participants
Secondary

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).6 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).8 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).6 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).6 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).3 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).6 Participants
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgNumber of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).5 Participants
Secondary

Overall Survival (OS)

OS is the average time from treatment initiation to death.

Time frame: Time from treatment initiation to death, up to 1-2 years.

Population: 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.

ArmMeasureValue (MEDIAN)Dispersion
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Overall Survival (OS)202 DaysStandard Deviation 332
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Overall Survival (OS)160 DaysStandard Deviation 196
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Overall Survival (OS)89 DaysStandard Deviation 124
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inOverall Survival (OS)167 DaysStandard Deviation 348
Secondary

Progression Free Survival (PFS)

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.

Time frame: Time from treatment initiation to disease progression or death, an average of 1 year.

Population: 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.

ArmMeasureValue (MEDIAN)
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Progression Free Survival (PFS)NA Months
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Progression Free Survival (PFS)NA Months
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Progression Free Survival (PFS)NA Months
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inProgression Free Survival (PFS)NA Months
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inProgression Free Survival (PFS)NA Months
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inProgression Free Survival (PFS)NA Months
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kgProgression Free Survival (PFS)NA Months
Secondary

Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)

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.

Time frame: up to 3 months

Population: 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.

ArmMeasureGroupValue (NUMBER)
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Progressive Disease0.21 Proportion of participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Complete Response0 Proportion of participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Not Evaluable0 Proportion of participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Stable Disease0.71 Proportion of participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Partial Response0.07 Proportion of participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Stable Disease0.5 Proportion of participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Progressive Disease0.36 Proportion of participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Not Evaluable0.07 Proportion of participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Complete Response0 Proportion of participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Partial Response0.07 Proportion of participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Stable Disease0.27 Proportion of participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Partial Response0 Proportion of participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Complete Response0 Proportion of participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Progressive Disease0.60 Proportion of participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Not Evaluable0.13 Proportion of participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inProportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Progressive Disease2 Proportion of participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inProportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Complete Response0 Proportion of participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inProportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Partial Response0 Proportion of participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inProportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Stable Disease0.4 Proportion of participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inProportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)Not Evaluable1 Proportion of participants
Other Pre-specified

Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUCinf)

Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0). It is used to characterize drug absorption.

Time frame: For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day 1.

Population: Extended serum drug concentrations are available for all participants during Cycle 1. During Cycle 2, these bloods were not drawn (per protocol) after the first few participants on study, therefore elimination rate and AUC could only be calculated for Cycle 1 in most patients. Results from all participants receiving 65 mcg/kg short infusion were combined for the pharmacokinetic analysis as all received the same dose of LMB-100.

ArmMeasureValue (MEAN)Dispersion
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUCinf)2,550 h*ng/mLStandard Deviation 38.2
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUCinf)1,409 h*ng/mLStandard Deviation 47.9
Other Pre-specified

Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf)/D (Dose)

The AUC is a measure of the serum concentration of the drug dose over time. It is used to characterize drug absorption.

Time frame: For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day 1.

Population: Extended serum drug concentrations are available for all participants during Cycle 1. During Cycle 2, these bloods were not drawn (per protocol) after the first few participants on study, therefore elimination rate and AUC could only be calculated for Cycle 1 in most patients. Results from all participants receiving 65 mcg/kg short infusion were combined for the pharmacokinetic analysis as all received the same dose of LMB-100.

ArmMeasureValue (MEAN)Dispersion
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf)/D (Dose)415 H*ng/mL/mgStandard Deviation 56.5
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf)/D (Dose)315 H*ng/mL/mgStandard Deviation 45.8
Other Pre-specified

Area Under the Serum Concentration Versus Time Curve Extrapolated to Last Measurement (AUClast)/D

The AUC is a measure of the serum concentration of the drug dose over time. It is used to characterize drug absorption

Time frame: For Arms B1 & B2: Pre-dose, end of loading dose, 2 and 6 hours after start of continuous infusion, end of infusion (EOI) and 2 hrs after EOI during Cycle 1 Day 1.

Population: Extended serum drug concentrations are avail. for all participants during C1. During C2, these bloods were not drawn (per protocol) after the first few participants on study, therefore elimination rate \& AUC could only be calculated for C1 in most pts. AUClast is reported for Arms B1 and B2 as the measurements taken do not permit calculation of AUCinf.

ArmMeasureValue (MEDIAN)Dispersion
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Area Under the Serum Concentration Versus Time Curve Extrapolated to Last Measurement (AUClast)/D519 h*ng/ml/mgStandard Deviation 604
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Area Under the Serum Concentration Versus Time Curve Extrapolated to Last Measurement (AUClast)/D229 h*ng/ml/mgStandard Deviation 71
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Area Under the Serum Concentration Versus Time Curve Extrapolated to Last Measurement (AUClast)/D233 h*ng/ml/mgStandard Deviation 64
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inArea Under the Serum Concentration Versus Time Curve Extrapolated to Last Measurement (AUClast)/D288 h*ng/ml/mgStandard Deviation 184
Other Pre-specified

Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm A1 and Arm A2

The maximum observed analyte concentration of dose was reported.

Time frame: For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day 1. Pre-dose and end of infusion (EOI) during Cycle 2 Day 1.

Population: LMB-100 peak plasma concentrations were available for all patients treated on study. Results from all participants receiving 65 mcg/kg short infusion (Arms A1 \& A2) were combined for the pharmacokinetic analysis as all received the same dose of LMB-100.

ArmMeasureGroupValue (MEAN)Dispersion
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm A1 and Arm A2Cycle 1 Day 1197 ng/mL/mgStandard Deviation 18.5
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm A1 and Arm A2Cycle 2 Day 1181 ng/mL/mg
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm A1 and Arm A2Cycle 1 Day 1188 ng/mL/mgStandard Deviation 77.7
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm A1 and Arm A2Cycle 2 Day 1158 ng/mL/mgStandard Deviation 51.9
Other Pre-specified

Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2

The maximum observed analyte concentration in serum was reported.

Time frame: For Arms B1 & B2: Pre-dose, end of loading dose, 2 and 6 hours after start of continuous infusion, end of infusion (EOI) and 2 hrs after EOI during Cycle 1 Day 1. Pre-dose, end of loading dose and EOI during Cycle 2 Day 1.

Population: LMB-100 peak plasma concentrations were available for all patients treated on study. The Cmax reported for Arms B1 DL2 and DL3R and for Arm B2 occurred at end of the loading dose. Only non-zero values are reported for two participants in Cycle 2.

ArmMeasureGroupValue (MEDIAN)Dispersion
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2Cycle 1 Day 1235 ng/mLStandard Deviation 398
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2Cycle 1 Day 126.3 ng/mLStandard Deviation 12.1
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2Cycle 2 Day 120.8 ng/mL
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2Cycle 1 Day 145.1 ng/mLStandard Deviation 18.5
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inMaximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2Cycle 1 Day 134.5 ng/mLStandard Deviation 19.8
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inMaximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2Cycle 2 Day 110.5 ng/mLStandard Deviation 5.9
Other Pre-specified

Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm A1 and Arm A2

The maximum observed analyte concentration in serum was reported.

Time frame: For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day. Pre-dose and end of infusion (EOI) during Cycle 2 Day 1.

Population: LMB-100 peak plasma concentrations were available for all patients treated on study. Results from all participants receiving 65 mcg/kg short infusion (Arms A1 \& A2) were combined for the pharmacokinetic analysis as all received the same dose of LMB-100.

ArmMeasureGroupValue (MEAN)Dispersion
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm A1 and Arm A2Cycle 1 Day 11,282 ng/mLStandard Deviation 14.9
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm A1 and Arm A2Cycle 2 Day 11,306 ng/mL
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm A1 and Arm A2Cycle 1 Day 1858.9 ng/mLStandard Deviation 43
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm A1 and Arm A2Cycle 2 Day 1748 ng/mLStandard Deviation 58.1
Other Pre-specified

Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2

The maximum observed analyte concentration in serum was reported.

Time frame: For Arms B1 & B2: Pre-dose, end of loading dose, 2 and 6 hours after start of continuous infusion, end of infusion (EOI) and 2 hrs after EOI during Cycle 1 Day 1. Pre-dose, end of loading dose and EOI during Cycle 2 Day 1.

Population: LMB-100 peak plasma concentrations were available for all patients treated on study. The Cmax reported for Arms B1 DL2 and DL3R and for Arm B2 occurred at end of the loading dose. Only non-zero values are reported for two participants in Cycle 2.

ArmMeasureGroupValue (MEDIAN)Dispersion
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2Cycle 1 Day 11124 ng/mLStandard Deviation 1892
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2Cycle 2 Day 1371 ng/mL
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2Cycle 1 Day 1488 ng/mLStandard Deviation 270
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2Cycle 1 Day 1485 ng/mLStandard Deviation 154
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inMaximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2Cycle 1 Day 1307 ng/mLStandard Deviation 163
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inMaximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2Cycle 2 Day 1195 ng/mLStandard Deviation 248
Other Pre-specified

Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)

A DLT is defined per protocol as events attributed to LMB-100 and occurring during the DLT period such as hematological toxicities: Grade 4 neutropenia, Grade 3 and 4 febrile neutropenia, Grade 4 thrombocytopenia, and Grade 3 thrombocytopenia associated with bleeding episodes. Grade ≥3 non-hematological toxicity with the exception of: Grade 3 nausea and vomiting without appropriate treatment, Grade 3 diarrhea lasting ≤2 days with no fever or dehydration, and isolated Grade 3 fever. Grade ≥4 non-hematological toxicity: infusion related reactions, and any other drug related toxicity qualified as a DLT per the discretion of the principal investigator.

Time frame: First 28 days following infusion of LMB-100 on Cycle 1, Day 1 through the duration of the study treatment up to 1 year.

Population: Arm A2 Phase 2 is not shown because it is not applicable due to dose expansion.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Edema0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Urine output decreased0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Fatigue1 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 1 creatinine increase0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Hypotension1 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 proteinuria0 Participants
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Myalgia2 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Fatigue0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Myalgia0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Hypotension0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Urine output decreased1 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Edema1 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 1 creatinine increase0 Participants
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 proteinuria0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Hypotension0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Fatigue0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Edema0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Urine output decreased0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 proteinuria1 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Myalgia0 Participants
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 1 creatinine increase0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Myalgia0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Edema0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Fatigue0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Hypotension0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Urine output decreased0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 proteinuria0 Participants
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 1 creatinine increase0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Hypotension0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Fatigue0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 1 creatinine increase1 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Edema0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 proteinuria0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Myalgia0 Participants
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Urine output decreased0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 1 creatinine increase0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Urine output decreased1 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Hypotension0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Fatigue0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 proteinuria0 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Edema1 Participants
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-inNumber of Participants Who Experienced a Dose Limiting Toxicity (DLT)Grade 3 Myalgia0 Participants
Other Pre-specified

Plasma Half-Life (T1/2) of LMB-100

Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.

Time frame: For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1, Day 1.

Population: LMB100 plasma conc. avail. for 20 pts on Arms A1/A2. Extended plasma drug conc. avail. for all pts during C1. During C2, these bloods were not drawn (per protocol) after1st few pts on study; elimination rate \& T1/2 could only be calc. for C1 in most pts. Results from all pts w/65 mcg/kg short infusion were combined for the pharmacokinetic analysis (all rec'd same dose LMB-100). Arms B1/B2 calc. of T1/2 was not planned \& plasma sample time points were inappropriate for computing this measure.

ArmMeasureValue (MEAN)Dispersion
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Plasma Half-Life (T1/2) of LMB-1001.25 hour(h)Standard Deviation 53.9
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Plasma Half-Life (T1/2) of LMB-1000.99 hour(h)Standard Deviation 12.9
Other Pre-specified

The Total Clearance (CL) of LMB-100

The CL is a quantitative measure of the rate at which a drug substance is removed from the body.

Time frame: For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day 1.

Population: LMB100 plasma conc. avail. for 20 pts on Arms A1/A2. Extended plasma drug conc. avail. for all pts during C1. During C2, these bloods were not drawn (per protocol) after1st few pts on study; elimination rate \& T1/2 could only be calc. for C1 in most pts. Results from all pts w/65 mcg/kg short infusion were combined for the pharmacokinetic analysis (all rec'd same dose LMB-100). Arms B1/B2 calc. of T1/2 was not planned \& plasma sample time points were inappropriate for computing this measure.

ArmMeasureValue (MEAN)Dispersion
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100The Total Clearance (CL) of LMB-1002.97 L/hStandard Deviation 44.3
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100The Total Clearance (CL) of LMB-1004.98 L/hStandard Deviation 116
Other Pre-specified

Time Curve Extrapolated to Last Measurement (AUClast) for LMB-100

Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated to last measurement. It is used to characterize drug absorption.

Time frame: For Arms B1 & B2: Pre-dose, end of loading dose, 2 and 6 hours after start of continuous infusion, end of infusion (EOI) and 2 hrs after EOI during Cycle 1.

Population: Extended serum drug concentrations are avail. for all participants during C1. During C2, these bloods were not drawn (per protocol) after the first few participants on study, therefore elimination rate \&AUC could only be calculated for C1 in most pts. AUClast is reported for Arms B1 and B2 as the measurements taken do not permit calculation of AUCinf.

ArmMeasureValue (MEAN)Dispersion
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Time Curve Extrapolated to Last Measurement (AUClast) for LMB-1002671 h*ng/mlStandard Deviation 2778
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Time Curve Extrapolated to Last Measurement (AUClast) for LMB-1004148 h*ng/mlStandard Deviation 1746
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Time Curve Extrapolated to Last Measurement (AUClast) for LMB-1002508 h*ng/mlStandard Deviation 388
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-inTime Curve Extrapolated to Last Measurement (AUClast) for LMB-1002417 h*ng/mlStandard Deviation 1006
Other Pre-specified

Volume of Distribution (Vd) of LMB-100

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

Time frame: For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1, Day 1.

Population: LMB100 plasma conc. avail. for 20 pts on Arms A1/A2. Extended plasma drug conc. avail. for all pts during C1. During C2, these bloods were not drawn (per protocol) after1st few pts on study; elimination rate \& T1/2 could only be calc. for C1 in most pts. Results from all pts w/65 mcg/kg short infusion were combined for the pharmacokinetic analysis (all rec'd same dose LMB-100). Arms B1/B2 calc. of T1/2 was not planned \& plasma sample time points were inappropriate for computing this measure.

ArmMeasureValue (MEAN)Dispersion
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100Volume of Distribution (Vd) of LMB-1004.91 LStandard Deviation 20.5
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100Volume of Distribution (Vd) of LMB-1007.48 LStandard Deviation 106

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026