Neoplasms, Pancreatic Neoplasms
Conditions
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.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Objective Response (OR) (Partial Responses + Complete Responses) in Phase 2 Subjects of Short Infusion LMB-100+ Nab-paclitaxel | Approximately 6 weeks after the start of treatment and continuing every 6 weeks until progression or start of a new treatment, up to 1 year | OR is defined as partial responses + complete response in participants in the phase 2 Arm A portion of the study assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete Response is a disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters |
| Maximum Tolerated Dose (MTD) of Short Infusion LMB-100 + Nab Paclitaxel | 21 days after LMB-100 is administered (end of cycle 1) | MTD is defined as the highest dose tolerated without exceeding a pre-set number of adverse events in Phase 1, Arm A. |
| Maximum Tolerated Dose (MTD) of Continuous Infusion LMB-100 | 21 days after LMB-100 is administered (end of cycle 1) | MTD is defined as the highest dose tolerated without exceeding a pre-set number of adverse events in Phase 1, 1 Arm B, single agent lead-in |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Objective Response (OR) (Partial Responses + Complete Responses) in Phase 1 Arm A1 | Approximately 6 weeks after the start of treatment and continuing every 6 weeks until progression or start of a new treatment up to 1 year. | OR is defined as partial response + complete response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete Response is a disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters |
| Number of Participants With an Objective Response (OR) (Partial Response + Complete Response) in Phase 1, Arm B | Approximately 6 weeks after the start of treatment and continuing every 6 weeks until progression or start of a new treatment up to 1 year. | OR is defined as partial responses + complete response in participants in the phase 1 Arm B portion of the study assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete Response is a disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. |
| 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-100 | Date treatment consent signed to date off study, approx. 11 mos, 8 days for A1DL1; 20 mos, 9 days for A1DL-1; 10 mos, 17 days for A2; 2 mos, 16 days for B1DL1; 14 mos, 30 days for B1DL2; 5 mos, 1 day for B2; and 4 mos, 15 days for B1DL3R. | Grade 1-4 adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 observed in subjects with pancreatic cancer. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe or medically significant. Grade 4 is life-threatening consequences. |
| 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 months | DCR is the proportion of participants with stable disease, partial response or complete response at end of treatment. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm A1 and Arm A2 | 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. | 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 B2 | 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. | 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)/D | 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. | 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-100 | 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. | 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-100 | For 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-100 | For 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-100 | For 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 A2 | 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. | The maximum observed analyte concentration in serum was reported. |
| Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2 | 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. | The maximum observed analyte concentration in serum was reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Arm A Dose Escalation | Adverse Event | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
| Arm B Dose Escalation | Adverse Event | 0 | 0 | 0 | 0 | 1 | 2 | 0 |
| Dose Expansion | Adverse Event | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Dose Expansion | Physician Decision | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100 | Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 15 Participants | 0 Participants | 3 Participants | 4 Participants | 2 Participants | 0 Participants | 3 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 6 Participants | 5 Participants | 2 Participants | 4 Participants | 3 Participants | 3 Participants | 2 Participants |
| Age, Continuous | 61.0 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/mL | 404.7 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 10 | 10106 Unit/mL | 0 Unit/mL | 10106 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 11 | 13.2 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 13.2 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 12 | 25180 Unit/mL | 0 Unit/mL | 25180 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 13 | 14.8 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 14.8 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 14 | 911.3 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 911.3 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 15 | 88.4 Unit/mL | 0 Unit/mL | 88.4 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 16 | 284.7 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 284.7 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 17 | 302.6 Unit/mL | 0 Unit/mL | 302.6 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 18 | 4206 Unit/mL | 0 Unit/mL | 4206 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 19 | 93.7 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 93.7 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 2 | 10650 Unit/mL | 10650 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 20 | 4482 Unit/mL | 0 Unit/mL | 4482 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 21 | 142.9 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 142.9 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 22 | 446.6 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 446.6 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 23 | 389.5 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 389.5 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 24 | 156.8 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 156.8 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 25 | 13348 Unit/mL | 0 Unit/mL | 13348 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 26 | 9254 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 9254 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 27 | 138.3 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 138.3 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 28 | 0.6 Unit/mL | 0 Unit/mL | 0.6 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 29 | 9571 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 9571 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 3 | 248800 Unit/mL | 248800 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 30 | 2077 Unit/mL | 0 Unit/mL | 0 Unit/mL | 2077 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 31 | 3424 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 3424 Unit/mL |
| Baseline CA 19-9 Patient 32 | 9326 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 9326 Unit/mL |
| Baseline CA 19-9 Patient 33 | 760 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 760 Unit/mL |
| Baseline CA 19-9 Patient 34 | 3297 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 3297 Unit/mL |
| Baseline CA 19-9 Patient 35 | 6345 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 6345 Unit/mL |
| Baseline CA 19-9 Patient 36 | 2966 Unit/mL | 0 Unit/mL | 0 Unit/mL | 2966 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 37 | 99.8 Unit/mL | 0 Unit/mL | 0 Unit/mL | 99.8 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 38 | 1340 Unit/mL | 0 Unit/mL | 0 Unit/mL | 1340 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 39 | 31440 Unit/mL | 0 Unit/mL | 0 Unit/mL | 31440 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 4 | 27.8 Unit/mL | 27.8 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 40 | 3857 Unit/mL | 0 Unit/mL | 0 Unit/mL | 3857 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 5 | 7081 Unit/mL | 7081 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 6 | 123 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 123 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 7 | 1277 Unit/mL | 1277 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 8 | 94210 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 94210 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Baseline CA 19-9 Patient 9 | 1500 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 0 Unit/mL | 1500 Unit/mL | 0 Unit/mL | 0 Unit/mL |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 6 Participants | 8 Participants | 5 Participants | 6 Participants | 3 Participants | 6 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Number of Participants with Prior Therapies Prior nab-paclitaxel | 20 Participants | 1 Participants | 3 Participants | 2 Participants | 5 Participants | 1 Participants | 5 Participants | 3 Participants |
| Number of Participants with Prior Therapies Radiation | 26 Participants | 5 Participants | 4 Participants | 5 Participants | 4 Participants | 2 Participants | 2 Participants | 4 Participants |
| Number of Participants with Prior Therapies Whipple | 20 Participants | 2 Participants | 5 Participants | 4 Participants | 2 Participants | 1 Participants | 3 Participants | 3 Participants |
| Number of Participants with Sites of Disease Ascites | 8 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants |
| Number of Participants with Sites of Disease Liver | 24 Participants | 4 Participants | 5 Participants | 4 Participants | 3 Participants | 3 Participants | 4 Participants | 1 Participants |
| Number of Participants with Sites of Disease Lung | 23 Participants | 2 Participants | 5 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants |
| Number of Participants with Sites of Disease Other | 25 Participants | 2 Participants | 3 Participants | 6 Participants | 5 Participants | 3 Participants | 3 Participants | 3 Participants |
| Participants Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 | 14 Participants | 2 Participants | 4 Participants | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants |
| Participants Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 1 | 24 Participants | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 1 Participants | 5 Participants | 3 Participants |
| Participants Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 2 | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Participants Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Unknown | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 32 Participants | 6 Participants | 7 Participants | 6 Participants | 4 Participants | 1 Participants | 4 Participants | 4 Participants |
| Region of Enrollment United States | 40 participants | 6 participants | 8 participants | 6 participants | 6 participants | 3 participants | 6 participants | 5 participants |
| Sex: Female, Male Female | 18 Participants | 2 Participants | 4 Participants | 4 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 22 Participants | 4 Participants | 4 Participants | 2 Participants | 4 Participants | 1 Participants | 5 Participants | 2 Participants |
Adverse events
| Event type | EG000 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 / 6 | 8 / 8 | 5 / 6 | 6 / 6 | 3 / 3 | 6 / 6 | 3 / 5 |
| other Total, other adverse events | 6 / 6 | 8 / 8 | 6 / 6 | 6 / 6 | 3 / 3 | 6 / 6 | 5 / 5 |
| serious Total, serious adverse events | 3 / 6 | 4 / 8 | 1 / 6 | 2 / 6 | 2 / 3 | 2 / 6 | 1 / 5 |
Outcome results
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Maximum Tolerated Dose (MTD) of Continuous Infusion LMB-100 | 100 Dose (µg/kg) |
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Maximum Tolerated Dose (MTD) of Short Infusion LMB-100 + Nab Paclitaxel | 65 µg/kg |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Objective Response (OR) (Partial Responses + Complete Responses) in Phase 2 Subjects of Short Infusion LMB-100+ Nab-paclitaxel | 1 Participants |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 2 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 2 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 1 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 4 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 2 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 4 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 1 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 2 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 2 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 1 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 1 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 4 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 2 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 3 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 1 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 2 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 1 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 2 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 3 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 2 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 1 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 1 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 6 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 3 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 1 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 1 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 1 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 1 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 2 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 1 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 1 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 2 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 1 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 1 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 4 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 1 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 1 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 1 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 1 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 7 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 2 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 2 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 6 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 2 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 2 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 1 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 4 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 4 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 1 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 1 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 5 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 1 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 3 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 6 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 1 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 4 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 1 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 1 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 6 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 1 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 2 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 1 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 1 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 2 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 1 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 1 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 1 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 7 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 1 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 1 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 2 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 2 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 1 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 1 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 1 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 1 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 1 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 0 Participants |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 1 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 1 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 1 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 1 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 1 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 1 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 3 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 4 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| Arm A2, Phase 2 Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 3 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 1 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 3 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 2 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 1 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 2 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 6 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 1 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 2 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 2 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 1 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 4 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 1 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 1 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 0 Participants |
| Arm A2, Phase 2 Grade 1 | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 1 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 1 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 1 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 1 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 1 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 1 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 1 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 1 Participants |
| Arm A2, Phase 2 Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 1 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 1 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 1 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm A2, Phase 2 Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 1 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 1 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 4 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 1 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 1 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 2 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 1 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 1 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 3 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 3 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 2 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 1 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 1 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 3 | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 1 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 0 Participants |
| Arm B1, Dose Level 2 Phase I Grade 4 | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 2 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 1 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 0 Participants |
| Arm B1, Dose Level 1 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 4 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 1 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 1 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| Arm B1, Dose Level 3R Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Tachycardia | 1 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | GI disturbances | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Decreased urine output | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dehydration | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Ascites | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dizziness | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoalbuminemia | 2 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pericardial effusion | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypoxia | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Rash and pruritis | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypotension | 2 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Proteinuria | 1 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Fever | 1 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Generalized pain | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Edema | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Creatinine increased | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Acute kidney injury | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Atrial fibrillation | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleural effusion | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Elevated LFT's | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Lymphocyte count decreased | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Chills | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Infusion-related reactions | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pleuritic pain | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Anemia | 1 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Ventricular dysfunction | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypocalcemia | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Anorexia | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hypophosphatemia | 1 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Pulmonary edema | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Nausea and vomiting | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Fatigue | 2 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Allergic reaction | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Cough | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Myalgia | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Weight gain | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Electrolyte disturbances | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Hyponatremia | 0 Participants |
| Arm B2 Phase I Grade 2 | Number of Participants With Adverse Events Attributed to LMB-100 | Dyspnea | 0 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With an Objective Response (OR) (Partial Response + Complete Response) in Phase 1, Arm B | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With an Objective Response (OR) (Partial Response + Complete Response) in Phase 1, Arm B | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With an Objective Response (OR) (Partial Response + Complete Response) in Phase 1, Arm B | 0 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants With an Objective Response (OR) (Partial Responses + Complete Responses) in Phase 1 Arm A1 | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants With an Objective Response (OR) (Partial Responses + Complete Responses) in Phase 1 Arm A1 | 1 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number 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-100 | Number 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-100 | Number 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-in | Number 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-in | Number 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-in | Number 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/kg | Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | 5 Participants |
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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Overall Survival (OS) | 202 Days | Standard Deviation 332 |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Overall Survival (OS) | 160 Days | Standard Deviation 196 |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Overall Survival (OS) | 89 Days | Standard Deviation 124 |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Overall Survival (OS) | 167 Days | Standard Deviation 348 |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Progression Free Survival (PFS) | NA Months |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Progression Free Survival (PFS) | NA Months |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Progression Free Survival (PFS) | NA Months |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Progression Free Survival (PFS) | NA Months |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Progression Free Survival (PFS) | NA Months |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Progression Free Survival (PFS) | NA Months |
| Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg | Progression Free Survival (PFS) | NA Months |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Progressive Disease | 0.21 Proportion of participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Complete Response | 0 Proportion of participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Not Evaluable | 0 Proportion of participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Stable Disease | 0.71 Proportion of participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Partial Response | 0.07 Proportion of participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Stable Disease | 0.5 Proportion of participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Progressive Disease | 0.36 Proportion of participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Not Evaluable | 0.07 Proportion of participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Complete Response | 0 Proportion of participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Partial Response | 0.07 Proportion of participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Stable Disease | 0.27 Proportion of participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Partial Response | 0 Proportion of participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Complete Response | 0 Proportion of participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Progressive Disease | 0.60 Proportion of participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Not Evaluable | 0.13 Proportion of participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Progressive Disease | 2 Proportion of participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Complete Response | 0 Proportion of participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Partial Response | 0 Proportion of participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Stable Disease | 0.4 Proportion of participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT) | Not Evaluable | 1 Proportion of participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUCinf) | 2,550 h*ng/mL | Standard Deviation 38.2 |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUCinf) | 1,409 h*ng/mL | Standard Deviation 47.9 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf)/D (Dose) | 415 H*ng/mL/mg | Standard Deviation 56.5 |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf)/D (Dose) | 315 H*ng/mL/mg | Standard Deviation 45.8 |
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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Area Under the Serum Concentration Versus Time Curve Extrapolated to Last Measurement (AUClast)/D | 519 h*ng/ml/mg | Standard Deviation 604 |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Area Under the Serum Concentration Versus Time Curve Extrapolated to Last Measurement (AUClast)/D | 229 h*ng/ml/mg | Standard Deviation 71 |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Area Under the Serum Concentration Versus Time Curve Extrapolated to Last Measurement (AUClast)/D | 233 h*ng/ml/mg | Standard Deviation 64 |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Area Under the Serum Concentration Versus Time Curve Extrapolated to Last Measurement (AUClast)/D | 288 h*ng/ml/mg | Standard Deviation 184 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm A1 and Arm A2 | Cycle 1 Day 1 | 197 ng/mL/mg | Standard Deviation 18.5 |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm A1 and Arm A2 | Cycle 2 Day 1 | 181 ng/mL/mg | — |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm A1 and Arm A2 | Cycle 1 Day 1 | 188 ng/mL/mg | Standard Deviation 77.7 |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm A1 and Arm A2 | Cycle 2 Day 1 | 158 ng/mL/mg | Standard Deviation 51.9 |
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.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2 | Cycle 1 Day 1 | 235 ng/mL | Standard Deviation 398 |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2 | Cycle 1 Day 1 | 26.3 ng/mL | Standard Deviation 12.1 |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2 | Cycle 2 Day 1 | 20.8 ng/mL | — |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2 | Cycle 1 Day 1 | 45.1 ng/mL | Standard Deviation 18.5 |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2 | Cycle 1 Day 1 | 34.5 ng/mL | Standard Deviation 19.8 |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2 | Cycle 2 Day 1 | 10.5 ng/mL | Standard Deviation 5.9 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm A1 and Arm A2 | Cycle 1 Day 1 | 1,282 ng/mL | Standard Deviation 14.9 |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm A1 and Arm A2 | Cycle 2 Day 1 | 1,306 ng/mL | — |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm A1 and Arm A2 | Cycle 1 Day 1 | 858.9 ng/mL | Standard Deviation 43 |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm A1 and Arm A2 | Cycle 2 Day 1 | 748 ng/mL | Standard Deviation 58.1 |
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.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2 | Cycle 1 Day 1 | 1124 ng/mL | Standard Deviation 1892 |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2 | Cycle 2 Day 1 | 371 ng/mL | — |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2 | Cycle 1 Day 1 | 488 ng/mL | Standard Deviation 270 |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2 | Cycle 1 Day 1 | 485 ng/mL | Standard Deviation 154 |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2 | Cycle 1 Day 1 | 307 ng/mL | Standard Deviation 163 |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2 | Cycle 2 Day 1 | 195 ng/mL | Standard Deviation 248 |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Edema | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Urine output decreased | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Fatigue | 1 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 1 creatinine increase | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Hypotension | 1 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 proteinuria | 0 Participants |
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Myalgia | 2 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Fatigue | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Myalgia | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Hypotension | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Urine output decreased | 1 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Edema | 1 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 1 creatinine increase | 0 Participants |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 proteinuria | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Hypotension | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Fatigue | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Edema | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Urine output decreased | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 proteinuria | 1 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Myalgia | 0 Participants |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 1 creatinine increase | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Myalgia | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Edema | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Fatigue | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Hypotension | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Urine output decreased | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 proteinuria | 0 Participants |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 1 creatinine increase | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Hypotension | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Fatigue | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 1 creatinine increase | 1 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Edema | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 proteinuria | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Myalgia | 0 Participants |
| Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Urine output decreased | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 1 creatinine increase | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Urine output decreased | 1 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Hypotension | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Fatigue | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 proteinuria | 0 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Edema | 1 Participants |
| Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Grade 3 Myalgia | 0 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Plasma Half-Life (T1/2) of LMB-100 | 1.25 hour(h) | Standard Deviation 53.9 |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Plasma Half-Life (T1/2) of LMB-100 | 0.99 hour(h) | Standard Deviation 12.9 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | The Total Clearance (CL) of LMB-100 | 2.97 L/h | Standard Deviation 44.3 |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | The Total Clearance (CL) of LMB-100 | 4.98 L/h | Standard Deviation 116 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Time Curve Extrapolated to Last Measurement (AUClast) for LMB-100 | 2671 h*ng/ml | Standard Deviation 2778 |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Time Curve Extrapolated to Last Measurement (AUClast) for LMB-100 | 4148 h*ng/ml | Standard Deviation 1746 |
| Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Time Curve Extrapolated to Last Measurement (AUClast) for LMB-100 | 2508 h*ng/ml | Standard Deviation 388 |
| Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in | Time Curve Extrapolated to Last Measurement (AUClast) for LMB-100 | 2417 h*ng/ml | Standard Deviation 1006 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100 | Volume of Distribution (Vd) of LMB-100 | 4.91 L | Standard Deviation 20.5 |
| Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 | Volume of Distribution (Vd) of LMB-100 | 7.48 L | Standard Deviation 106 |