Advanced Solid Tumors
Conditions
Keywords
Tumors, Antibodies, Monoclonal
Brief summary
The purpose of this study is to determine if IMC-A12 is safe for participants, and also to determine the best dose of IMC-A12 to give to participants.
Detailed description
The purpose of this study is to establish the safety profile and maximum tolerated dose (MTD) of the anti-IGF-IR monoclonal antibody IMC-A12 administered weekly in participants with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available
Interventions
BIOLOGICALIMC-A12
Cohort 1 3 milligrams/kilogram (mg/kg), I.V. once a week, for 4 weeks, followed by a 2-week observation period.
Sponsors
Eli Lilly and Company
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histopathologically-documented, measurable, advanced primary or recurrent solid tumors that no longer respond to standard therapy or for which no standard therapy is available. * Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2 at study entry * Able to provide written informed consent * Life expectancy of \>3 months * Adequate hematologic functions, as defined by: absolute neutrophil count (ANC) ≥1500/cubic millimeter (mm³), hemoglobin level ≥10 grams/deciliter (gm/dL), platelet count ≥100,000/mm³ * Adequate hepatic function, as defined by: total bilirubin level ≤1.5 x the upper limit of normal (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤2.5 x the ULN or ≤5 x the ULN if known liver metastases * Adequate renal function, as defined by a serum creatinine level ≤1.5 x the ULN * Ejection fraction within the normal institutional limits * Use of effective contraception per institutional standard, if procreative potential exists * At least 28 days must have elapsed from major surgery, prior chemotherapy, prior treatment with an investigational agent or device, prior radiation therapy (palliative radiation therapy is allowed), an open biopsy, or a significant traumatic injury to allow for adequate recovery. Ongoing side effects due to these agents must be ≤Grade 2 prior to entering the study. * At least 6 weeks must have elapsed from nitrosoureas, mitomycin C, or monoclonal antibody \[not targeting the insulin-like growth factor receptor (IGFR)\] therapy to allow for adequate recovery. Ongoing side effects due to these agents must be ≤Grade 2 prior to entering the study. * Accessible for treatment and follow-up. Participants enrolled in this trial must be treated at the participating center.
Exclusion criteria
* Any concurrent malignancy other than non-melanomatous skin cancer or carcinoma in situ of the cervix. Participants with a previous malignancy but without evidence of disease for ≥3 years will be allowed to enter the trial. * Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring parenteral antibiotics, symptomatic congestive heart failure, unstable angina pectoris, angioplasty, stenting or myocardial infarction within 6 months, uncontrolled hypertension, clinically significant cardiac arrhythmia, psychiatric illness/social situations that would compromise participant safety or limit compliance with study requirements, participants with symptomatic brain metastases * Serious or nonhealing active wound, ulcer or bone fracture * Know human immunodeficiency virus (HIV)-positive * History of hemorrhagic or thrombotic disorder within 9 months * Proteinuria ≥1+ by routine urinalysis (participants with a protein value of ≤500 milligrams (mg) confirmed by a 24-hour urine collection are eligible) * Pregnant \[confirmed by serum beta human chorionic gonadotropin (βHCG)\] or breast feeding * History of prior treatment with other agents specifically targeting IGFRs * Known diabetes * Inability or unwillingness to interrupt steroidal or hormonal therapy for the duration of treatment with IMC-A12 * Positive anti-IMC-A12 antibody response * History of allergic reactions to monoclonal antibodies or other therapeutic proteins * Employees of the investigator or study center with direct involvement in this study or other studies under the direction of the investigator or study center, as well as family members of the employees.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) or Deaths | Enrollment to study completion up to 215 weeks | Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module. |
| Maximum Tolerated Dose (MTD) | 6 weeks | The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT). A DLT was defined as any Grade 3 or 4 hematologic or nonhematologic toxicity based on Common Terminology Criteria for AE (CTCAE), excluding alopecia, which was considered by the investigator to be definitely, probably, or possibly related to IMC-A12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Serum Concentration Versus Time Curve of IMC-A12 During One Dosing Interval (AUCτ) Following Multiple Doses | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 | — |
| Half-Life (t1/2) of IMC-A12 Following Multiple Doses | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 | Half-Life (t1/2) is the time measured for the plasma concentration of the drug to decrease by one half. The analysis was not performed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data. |
| Clearance Rate of IMC-A12 at Steady State (CLss) Following Multiple Doses | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 | CLss is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time at steady-state. |
| Maximum Concentration (Cmax) of IMC-A12 Following Multiple Doses | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 | — |
| Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity) | Before the last infusion of each treatment cycle | Analysis was not performed due to lack of available assay. |
| Number of Participants With Best Overall Response | Enrollment to study completion up to 215 weeks | Stable Disease (SD) is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD). PR and PD were assessed by investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. Participants with a global deterioration of their health status requiring discontinuation of treatment without objective evidence of disease progression at that time were to be reported as symptomatic deterioration |
| Volume of Distribution of IMC-A12 at Steady State (Vss) Following Multiple Doses | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 | Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug at steady-state. The analysis was not performed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data. |
| Observed Serum Concentration of IMC-A12 at 168 Hour Post End of Infusion Following Multiple Doses | Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1 | — |
Countries
United States
Participant flow
Recruitment details
For participants enrolled under Protocol Versions 1.0 and 2.0, there was a 2-week pharmacokinetic (PK) period prior to Cycle 1.
Pre-assignment details
After completion of the 10 milligrams/kilogram (mg/kg) cohort, PK data were obtained that established a recommended dose for Phase 2 studies. Enrollment and dose escalation beyond 15 mg/kg was stopped. Participants with progressive disease (PD) or death were considered to have completed the study.
Participants by arm
| Arm | Count |
|---|---|
| 3 mg/kg 3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. | 7 |
| 6 mg/kg 6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. | 9 |
| 10 mg/kg 10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. | 6 |
| 15 mg/kg 15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule. | 2 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Treatment Period | Adverse Event | 1 | 2 | 2 | 0 |
| Treatment Period | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | 3 mg/kg | 6 mg/kg | 10 mg/kg | 15 mg/kg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 65.7 years FULL_RANGE 10.43 | 56.4 years FULL_RANGE 6.3 | 59.4 years FULL_RANGE 15.17 | 42.9 years FULL_RANGE 15.13 | 57.2 years FULL_RANGE 11.13 |
| Race/Ethnicity, Customized Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 8 Participants | 5 Participants | 1 Participants | 18 Participants |
| Region of Enrollment United States | 7 Participants | 9 Participants | 6 Participants | 2 Participants | 24 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 1 Participants | 1 Participants | 10 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 5 Participants | 1 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 7 | 8 / 9 | 6 / 6 | 2 / 2 |
| serious Total, serious adverse events | 2 / 7 | 3 / 9 | 2 / 6 | 0 / 2 |
Outcome results
Primary
Maximum Tolerated Dose (MTD)
The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT). A DLT was defined as any Grade 3 or 4 hematologic or nonhematologic toxicity based on Common Terminology Criteria for AE (CTCAE), excluding alopecia, which was considered by the investigator to be definitely, probably, or possibly related to IMC-A12.
Time frame: 6 weeks
Population: All participants who received at least 1 dose of study drug and completed Cycle 1 and 2-week observation or discontinued treatment for an IMC-A12-related toxicity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 3 mg/kg | Maximum Tolerated Dose (MTD) | NA mg/kg |
| 6 mg/kg | Maximum Tolerated Dose (MTD) | NA mg/kg |
| 10 mg/kg | Maximum Tolerated Dose (MTD) | NA mg/kg |
| 15 mg/kg | Maximum Tolerated Dose (MTD) | NA mg/kg |
Primary
Number of Participants With Adverse Events (AEs) or Deaths
Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Time frame: Enrollment to study completion up to 215 weeks
Population: All enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 3 mg/kg | Number of Participants With Adverse Events (AEs) or Deaths | Death due to PD | 0 Participants |
| 3 mg/kg | Number of Participants With Adverse Events (AEs) or Deaths | AEs | 7 Participants |
| 3 mg/kg | Number of Participants With Adverse Events (AEs) or Deaths | SAEs | 2 Participants |
| 6 mg/kg | Number of Participants With Adverse Events (AEs) or Deaths | AEs | 8 Participants |
| 6 mg/kg | Number of Participants With Adverse Events (AEs) or Deaths | Death due to PD | 1 Participants |
| 6 mg/kg | Number of Participants With Adverse Events (AEs) or Deaths | SAEs | 3 Participants |
| 10 mg/kg | Number of Participants With Adverse Events (AEs) or Deaths | SAEs | 2 Participants |
| 10 mg/kg | Number of Participants With Adverse Events (AEs) or Deaths | Death due to PD | 0 Participants |
| 10 mg/kg | Number of Participants With Adverse Events (AEs) or Deaths | AEs | 6 Participants |
| 15 mg/kg | Number of Participants With Adverse Events (AEs) or Deaths | Death due to PD | 0 Participants |
| 15 mg/kg | Number of Participants With Adverse Events (AEs) or Deaths | SAEs | 0 Participants |
| 15 mg/kg | Number of Participants With Adverse Events (AEs) or Deaths | AEs | 2 Participants |
Secondary
Area Under the Serum Concentration Versus Time Curve of IMC-A12 During One Dosing Interval (AUCτ) Following Multiple Doses
Time frame: Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1
Population: All participants who received study drug and had PK data available to calculate AUCτ.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg/kg | Area Under the Serum Concentration Versus Time Curve of IMC-A12 During One Dosing Interval (AUCτ) Following Multiple Doses | 19800 micrograms*hour/milliliter (µg*h/mL | Geometric Coefficient of Variation 39 |
| 6 mg/kg | Area Under the Serum Concentration Versus Time Curve of IMC-A12 During One Dosing Interval (AUCτ) Following Multiple Doses | 36350 micrograms*hour/milliliter (µg*h/mL | — |
| 10 mg/kg | Area Under the Serum Concentration Versus Time Curve of IMC-A12 During One Dosing Interval (AUCτ) Following Multiple Doses | 66700 micrograms*hour/milliliter (µg*h/mL | — |
| 15 mg/kg | Area Under the Serum Concentration Versus Time Curve of IMC-A12 During One Dosing Interval (AUCτ) Following Multiple Doses | 49300 micrograms*hour/milliliter (µg*h/mL | — |
Secondary
Clearance Rate of IMC-A12 at Steady State (CLss) Following Multiple Doses
CLss is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time at steady-state.
Time frame: Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1
Population: All participants who received study drug and had PK data available to calculate CLss.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg/kg | Clearance Rate of IMC-A12 at Steady State (CLss) Following Multiple Doses | 0.0124 Liters/hour (L/h) | Geometric Coefficient of Variation 40 |
| 6 mg/kg | Clearance Rate of IMC-A12 at Steady State (CLss) Following Multiple Doses | 0.0125 Liters/hour (L/h) | — |
| 10 mg/kg | Clearance Rate of IMC-A12 at Steady State (CLss) Following Multiple Doses | 0.0114 Liters/hour (L/h) | — |
| 15 mg/kg | Clearance Rate of IMC-A12 at Steady State (CLss) Following Multiple Doses | 0.0296 Liters/hour (L/h) | — |
Secondary
Half-Life (t1/2) of IMC-A12 Following Multiple Doses
Half-Life (t1/2) is the time measured for the plasma concentration of the drug to decrease by one half. The analysis was not performed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.
Time frame: Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1
Population: All participants who received study drug and had PK data available to calculate t1/2. Zero participants were analyzed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 3 mg/kg | Half-Life (t1/2) of IMC-A12 Following Multiple Doses | 6.19 days |
| 15 mg/kg | Half-Life (t1/2) of IMC-A12 Following Multiple Doses | 6.17 days |
Secondary
Maximum Concentration (Cmax) of IMC-A12 Following Multiple Doses
Time frame: Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1
Population: All participants who received study drug and had PK data available to calculate Cmax.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg/kg | Maximum Concentration (Cmax) of IMC-A12 Following Multiple Doses | 292 micrograms/milliliter (µg/mL) | Geometric Coefficient of Variation 42 |
| 6 mg/kg | Maximum Concentration (Cmax) of IMC-A12 Following Multiple Doses | 385 micrograms/milliliter (µg/mL) | Geometric Coefficient of Variation 51 |
| 10 mg/kg | Maximum Concentration (Cmax) of IMC-A12 Following Multiple Doses | 734 micrograms/milliliter (µg/mL) | — |
| 15 mg/kg | Maximum Concentration (Cmax) of IMC-A12 Following Multiple Doses | 965 micrograms/milliliter (µg/mL) | — |
Secondary
Number of Participants With Best Overall Response
Stable Disease (SD) is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD). PR and PD were assessed by investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. Participants with a global deterioration of their health status requiring discontinuation of treatment without objective evidence of disease progression at that time were to be reported as symptomatic deterioration
Time frame: Enrollment to study completion up to 215 weeks
Population: All enrolled participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 3 mg/kg | Number of Participants With Best Overall Response | Progressive Disease (PD) | 5 Participants |
| 3 mg/kg | Number of Participants With Best Overall Response | Stable Disease (SD) | 2 Participants |
| 3 mg/kg | Number of Participants With Best Overall Response | Symptomatic Deterioration | 0 Participants |
| 3 mg/kg | Number of Participants With Best Overall Response | Not Evaluable | 0 Participants |
| 3 mg/kg | Number of Participants With Best Overall Response | Partial Response (PR) | 0 Participants |
| 6 mg/kg | Number of Participants With Best Overall Response | Stable Disease (SD) | 1 Participants |
| 6 mg/kg | Number of Participants With Best Overall Response | Progressive Disease (PD) | 4 Participants |
| 6 mg/kg | Number of Participants With Best Overall Response | Symptomatic Deterioration | 3 Participants |
| 6 mg/kg | Number of Participants With Best Overall Response | Not Evaluable | 1 Participants |
| 6 mg/kg | Number of Participants With Best Overall Response | Partial Response (PR) | 0 Participants |
| 10 mg/kg | Number of Participants With Best Overall Response | Stable Disease (SD) | 2 Participants |
| 10 mg/kg | Number of Participants With Best Overall Response | Partial Response (PR) | 0 Participants |
| 10 mg/kg | Number of Participants With Best Overall Response | Not Evaluable | 2 Participants |
| 10 mg/kg | Number of Participants With Best Overall Response | Symptomatic Deterioration | 0 Participants |
| 10 mg/kg | Number of Participants With Best Overall Response | Progressive Disease (PD) | 2 Participants |
| 15 mg/kg | Number of Participants With Best Overall Response | Symptomatic Deterioration | 0 Participants |
| 15 mg/kg | Number of Participants With Best Overall Response | Not Evaluable | 0 Participants |
| 15 mg/kg | Number of Participants With Best Overall Response | Partial Response (PR) | 0 Participants |
| 15 mg/kg | Number of Participants With Best Overall Response | Stable Disease (SD) | 1 Participants |
| 15 mg/kg | Number of Participants With Best Overall Response | Progressive Disease (PD) | 1 Participants |
Secondary
Observed Serum Concentration of IMC-A12 at 168 Hour Post End of Infusion Following Multiple Doses
Time frame: Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1
Population: All participants who received study drug and had PK data available to calculate Cmin.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 3 mg/kg | Observed Serum Concentration of IMC-A12 at 168 Hour Post End of Infusion Following Multiple Doses | 74.8 µg/mL | Geometric Coefficient of Variation 28 |
| 6 mg/kg | Observed Serum Concentration of IMC-A12 at 168 Hour Post End of Infusion Following Multiple Doses | 154 µg/mL | — |
| 10 mg/kg | Observed Serum Concentration of IMC-A12 at 168 Hour Post End of Infusion Following Multiple Doses | 226 µg/mL | — |
| 15 mg/kg | Observed Serum Concentration of IMC-A12 at 168 Hour Post End of Infusion Following Multiple Doses | 122 µg/mL | — |
Secondary
Serum Anti-IMC-A12 Antibody Assessment (Immunogenicity)
Analysis was not performed due to lack of available assay.
Time frame: Before the last infusion of each treatment cycle
Population: Zero participants were analyzed due to lack of available assay.
Secondary
Volume of Distribution of IMC-A12 at Steady State (Vss) Following Multiple Doses
Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug at steady-state. The analysis was not performed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.
Time frame: Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1
Population: All participants who received study drug and had PK data available to calculate Vss. Zero participants were analyzed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 3 mg/kg | Volume of Distribution of IMC-A12 at Steady State (Vss) Following Multiple Doses | 2.88 Liters (L) |
| 15 mg/kg | Volume of Distribution of IMC-A12 at Steady State (Vss) Following Multiple Doses | 5.19 Liters (L) |