Cutaneous Melanoma, Metastatic Melanoma
Conditions
Keywords
KW2871, Ecromeximab, Anti-ganglioside, Antibody, Interferon alpha, Metastatic melanoma
Brief summary
This was a Phase 2, open-label study of KW2871 (ecromeximab) in combination with high-dose interferon-α2b (HDI) in patients with metastatic melanoma. The primary objectives of this study were to assess progression-free survival (PFS) and safety. The secondary objectives were to assess the objective response rate, KW2871 pharmacokinetics (PK), and other exploratory immunology as indicated (e.g., development of human anti-chimeric antibodies \[HACA\], activity of antibody-dependent cell-mediated cytotoxicity \[ADCC\] and complement-dependent cytotoxicity \[CDC\] in peripheral blood, number and functional state of tumor-infiltrating immune cells and expression of GD3 in immune and tumor cells of tumor biopsies, and markers of interferon \[IFN\] response/resistance and markers of resistance to ADCC/CDC in peripheral blood mononuclear cells \[PBMCs\]).
Detailed description
Eligible patients were sequentially enrolled into dose-escalating cohorts to receive KW2871 intravenously (IV) once every 2 weeks starting on Day 3 of Week 1 at the following doses: 5 mg/m\^2 in Cohort 1, 10 mg/m\^2 in Cohort 2, and 20 mg/m\^2 in Cohort 3. HDI was administered concurrently at a dose of 20 million units (MU)/m\^2 IV once daily (QD) for 5 consecutive days per week for 4 weeks (induction phase), followed by 10 MU/m\^2 administered subcutaneously (SC) 3 times per week (maintenance phase). Patients received KW2871 and HDI combination therapy until disease progression requiring treatment intervention that would have interfered with the interpretation of the study results. Initially, 3 patients were enrolled within a cohort and evaluated for dose-limiting toxicity (DLT) and regimen-limiting toxicity (RLT) for the first 8 weeks of study treatment. If 1 of 3 patients experienced an RLT, the cohort was expanded to 6 patients. Escalation to the next higher dose cohort proceeded if the RLT rate was \<33% (0/3 or 1/6 patients) in a given cohort. The combination treatment was considered safe if ≤ 20% patients experienced RLT. DLT was defined as any adverse event (AE) that required reduction of the HDI dose or discontinuation of KW2871. RLT was defined as an HDI-related DLT that required more than 2 dose reductions of HDI during the induction phase or the first 4 weeks of the maintenance phase, or any KW2871- or regimen-related DLT.
Interventions
DRUGHDI
20 MU/m\^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m\^2 SC 3 days/week until disease progression
DRUGKW2871
5 mg/m\^2 IV every 2 weeks until disease progression
Sponsors
University of Pittsburgh
University of Chicago
Life Science Pharmaceuticals
Ludwig Institute for Cancer Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose-escalation cohorts
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years of age. 2. Histologically proven metastatic cutaneous, mucosal, or unknown primary melanoma. 3. Measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST). 4. Ambulatory (Eastern Cooperative Oncology Group \[ECOG\] performance status 0 or 1) or expected survival ≥ 4 months. 5. Within the last 2 weeks prior to study day 1, the following laboratory parameters within the ranges specified: * Hemoglobin: ≥ 9 g/dL * Platelets: ≥ 100 x 10\^9/L * Neutrophils: ≥ 1.5 x 10\^9/L * International normalized ratio: ≤ 2.0 (≤ 3.0 if on warfarin therapy) * Serum creatinine: ≤ 1.5 x upper limit of normal (ULN) * Serum total bilirubin: ≤ 1.5 x ULN * Aspartate aminotransferase/alanine aminotransferase: ≤ 2.5 x ULN 6. Able and willing to give valid written informed consent.
Exclusion criteria
1. Other malignancy within 3 years prior to study entry for which the patient received active treatment, except for treated melanoma or non-melanoma skin cancer, cervical cancer, and breast carcinoma in situ. 2. Mental impairment that may have compromised the ability to give informed consent and comply with the study requirements. 3. Participation in any other clinical trial involving chemotherapy, radiotherapy, or other immunotherapy within 4 weeks prior to study enrollment. 4. Prior exposure to anti-GD3 antibodies. 5. Pregnancy or breastfeeding. 6. Women of childbearing potential who refused or were unable to use effective means of contraception. 7. Active autoimmune or other disorders that required systemic treatment with immunomodulatory or immunosuppressant medications (i.e., corticosteroids, cyclophosphamide, methotrexate, other biologics). Corticosteroids at substitution doses were allowed. 8. Metastatic brain disease was allowed provided that appropriate treatment had been administered (surgery or irradiation) and 2-month follow-up by brain magnetic resonance imaging (MRI) showed disease control (stability or regression). 9. Autoimmune-related hypothyroidism and vitiligo-like depigmentation were allowed provided the patient was medically stable with treatment (thyroid-hormone replacement or observation). 10. Serious medical illness, such as cardiovascular disease (uncontrolled congestive heart failure or hypertension, active ischemic disease of the heart \[angina\], recent \[\<3 months\] myocardial infarction, severe cardiac arrhythmia), bleeding disorders, obstructive or restrictive pulmonary diseases, active systemic infections requiring antibiotics, serious intercurrent illness requiring hospitalization, inflammatory bowel disorders, or significant psychiatric disease, which in the opinion of the principal investigator would have prevented adequate informed consent or rendered study treatment unsafe or contraindicated. 11. Patients with clinical suspicion of human immunodeficiency virus (HIV) or hepatitis underwent the following viral tests: patients with HIV must have had negative antibodies; patients with hepatitis B virus must have had negative antigens; patients with hepatitis C virus must have had a negative test for serum antibodies. If any of the tests were positive, patients were excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Progression-free Survival (PFS) With 95% Confidence Intervals | From baseline through up to 17 months post-baseline | PFS was calculated from the date of the first infusion to the date of documented progression or death, whichever occurred first. PFS analyses were performed using Kaplan-Meier methods for all patients combined and for patients in Cohort 3. Based on published results from Phase 3 randomized clinical trials in patients with metastatic melanoma at the time of study initiation, 2.5 months was estimated as a conservative (i.e., somewhat high) external standard of median PFS. The intent of this study was to improve this standard by ≥ 70% to a median PFS of ≥ 4.3 months for patients treated with KW2871 combined with HDI. If the therapeutic target of 4.3 months for median PFS represented the true underlying treatment effect of KW2871 plus HDI, then 23 patients would provide 80% power to detect a statistically significant improvement (α = 0.05; 1-sided test) over the 2.5-month external standard. |
| Number of Patients With Treatment-emergent Adverse Events (TEAEs) | From baseline through up to 17 months post-baseline | Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), or Grade 5 (fatal). TEAEs were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Causal relationship of each TEAE to study treatment was evaluated by the investigator separately for HDI and KW2871. Regimen-limiting toxicity was defined as an HDI-related dose-limiting toxicity (DLT) that required more than 2 dose reductions of HDI during the induction phase or the first 4 weeks of the maintenance phase, or any KW2871- or regimen-related DLT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Best Overall Tumor Response | From baseline through up to 17 months post-baseline | Tumor responses were evaluated using whole body computed tomography and categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0) at Screening, on Days 29, 57, 85, 115, 143, 171, 227, 283, 339, and at the End of Study Visit. Patients who were treated beyond 49 weeks were to undergo clinical and radiologic assessments per the standard of care. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions \[no evidence of disease\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria. |
| Number of Patients With Human Antichimeric Antibody (HACA) Reactivity To KW2871 | From baseline through up to 17 months post-baseline | Blood samples were collected for the analysis of HACA at baseline, on Days 29, 115, 143, 171, 199, 227, 255, 283, 311, 339, and at the End of Study visit. Measurement of HACA development in plasma was performed with a BIAcore 2000 biosensor (Biacore AB, Uppsala, Sweden), using the BDF TM015 method. HACA positivity was defined as an increase in binding evident in the test channel but not in the control channel, with positivity assigned for values exceeding a uniform test threshold. |
| Maximum KW2871 Antibody Levels in Plasma Following the First Infusion | At Baseline and Study Day 3 | Blood samples for pharmacokinetic (PK) measurements were collected at baseline and before and 30 minutes after the initial KW2871 infusion on Day 3. The KW2871 antibody protein in patient serum was measured using an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantitation was determined to be 100 ng/mL. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 KW2871: 5 mg/m\^2 IV every 2 weeks
HDI: 20 MU/m\^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m\^2 SC 3 days/week | 6 |
| Cohort 2 KW2871: 10 mg/m\^2 IV every 2 weeks
HDI: 20 MU/m\^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m\^2 SC 3 days/week | 6 |
| Cohort 3 KW2871: 20 mg/m\^2 IV every 2 weeks
HDI: 20 MU/m\^2 IV QD for 5 days/week for 4 weeks, then 10 MU/m\^2 SC 3 days/week | 24 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 3 |
| Overall Study | Physician Decision | 1 | 0 | 1 |
| Overall Study | Progressive disease | 4 | 5 | 18 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Cohort 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 55 years | 61 years | 54 years | 54 years |
| Body Mass Index | 24.4 kg/m^2 | 29.4 kg/m^2 | 26.3 kg/m^2 | 26.5 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants | 24 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants | 24 Participants | 36 Participants |
| Region of Enrollment United States | 6 Participants | 6 Participants | 24 Participants | 36 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 13 Participants | 18 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 11 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 1 / 6 | 1 / 24 |
| other Total, other adverse events | 6 / 6 | 6 / 6 | 24 / 24 |
| serious Total, serious adverse events | 2 / 6 | 1 / 6 | 7 / 24 |
Outcome results
Primary
Median Progression-free Survival (PFS) With 95% Confidence Intervals
PFS was calculated from the date of the first infusion to the date of documented progression or death, whichever occurred first. PFS analyses were performed using Kaplan-Meier methods for all patients combined and for patients in Cohort 3. Based on published results from Phase 3 randomized clinical trials in patients with metastatic melanoma at the time of study initiation, 2.5 months was estimated as a conservative (i.e., somewhat high) external standard of median PFS. The intent of this study was to improve this standard by ≥ 70% to a median PFS of ≥ 4.3 months for patients treated with KW2871 combined with HDI. If the therapeutic target of 4.3 months for median PFS represented the true underlying treatment effect of KW2871 plus HDI, then 23 patients would provide 80% power to detect a statistically significant improvement (α = 0.05; 1-sided test) over the 2.5-month external standard.
Time frame: From baseline through up to 17 months post-baseline
Population: Patients who received initial treatment with HDI and at least 1 infusion of KW2871 and experienced a PFS event (progression or death).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 3 | Median Progression-free Survival (PFS) With 95% Confidence Intervals | 1.93 months |
| Total | Median Progression-free Survival (PFS) With 95% Confidence Intervals | 2.53 months |
Primary
Number of Patients With Treatment-emergent Adverse Events (TEAEs)
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), or Grade 5 (fatal). TEAEs were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Causal relationship of each TEAE to study treatment was evaluated by the investigator separately for HDI and KW2871. Regimen-limiting toxicity was defined as an HDI-related dose-limiting toxicity (DLT) that required more than 2 dose reductions of HDI during the induction phase or the first 4 weeks of the maintenance phase, or any KW2871- or regimen-related DLT.
Time frame: From baseline through up to 17 months post-baseline
Population: Patients who received initial treatment with HDI and at least 1 infusion of KW2871.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any TEAE | 6 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Maximum TEAE Severity Grade 1/2 | 0 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Maximum TEAE Severity Grade 3 | 5 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Maximum TEAE Severity Grade 4 | 1 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Maximum TEAE Severity Grade 5 | 0 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any HDI-related TEAE | 6 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any KW2871-related TEAE | 4 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any SAE | 2 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any TEAE leading to withdrawal of HDI+KW2871 | 0 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any TEAE leading to withdrawal of HDI only | 0 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any TEAE leading to withdrawal of KW2871 only | 0 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Regimen-limiting toxicity | 0 Participants |
| Total | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Regimen-limiting toxicity | 0 Participants |
| Total | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any TEAE | 6 Participants |
| Total | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any KW2871-related TEAE | 5 Participants |
| Total | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any TEAE leading to withdrawal of HDI+KW2871 | 1 Participants |
| Total | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Maximum TEAE Severity Grade 1/2 | 1 Participants |
| Total | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any HDI-related TEAE | 6 Participants |
| Total | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any TEAE leading to withdrawal of KW2871 only | 0 Participants |
| Total | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Maximum TEAE Severity Grade 3 | 2 Participants |
| Total | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any SAE | 1 Participants |
| Total | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Maximum TEAE Severity Grade 5 | 1 Participants |
| Total | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Maximum TEAE Severity Grade 4 | 2 Participants |
| Total | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any TEAE leading to withdrawal of HDI only | 0 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Maximum TEAE Severity Grade 4 | 1 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Maximum TEAE Severity Grade 5 | 1 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any TEAE leading to withdrawal of HDI only | 1 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any HDI-related TEAE | 24 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any KW2871-related TEAE | 7 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any SAE | 7 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any TEAE leading to withdrawal of KW2871 only | 1 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any TEAE | 24 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Maximum TEAE Severity Grade 1/2 | 2 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Any TEAE leading to withdrawal of HDI+KW2871 | 3 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Maximum TEAE Severity Grade 3 | 20 Participants |
| Cohort 3 | Number of Patients With Treatment-emergent Adverse Events (TEAEs) | Regimen-limiting toxicity | 2 Participants |
Secondary
Maximum KW2871 Antibody Levels in Plasma Following the First Infusion
Blood samples for pharmacokinetic (PK) measurements were collected at baseline and before and 30 minutes after the initial KW2871 infusion on Day 3. The KW2871 antibody protein in patient serum was measured using an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantitation was determined to be 100 ng/mL.
Time frame: At Baseline and Study Day 3
Population: Patients who received initial treatment with HDI and at least 1 infusion of KW2871 and had at least 1 plasma sample evaluated for KW2871 antibody levels.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 3 | Maximum KW2871 Antibody Levels in Plasma Following the First Infusion | 3.22 µg/mL | Standard Deviation 3.02 |
| Total | Maximum KW2871 Antibody Levels in Plasma Following the First Infusion | 5.17 µg/mL | Standard Deviation 5.07 |
| Cohort 3 | Maximum KW2871 Antibody Levels in Plasma Following the First Infusion | 9.18 µg/mL | Standard Deviation 4.26 |
Secondary
Number of Patients With Best Overall Tumor Response
Tumor responses were evaluated using whole body computed tomography and categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0) at Screening, on Days 29, 57, 85, 115, 143, 171, 227, 283, 339, and at the End of Study Visit. Patients who were treated beyond 49 weeks were to undergo clinical and radiologic assessments per the standard of care. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions \[no evidence of disease\]; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.
Time frame: From baseline through up to 17 months post-baseline
Population: Patients who received initial treatment with HDI and at least 1 infusion of KW2871.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 3 | Number of Patients With Best Overall Tumor Response | CR | 0 Participants |
| Cohort 3 | Number of Patients With Best Overall Tumor Response | PD | 0 Participants |
| Cohort 3 | Number of Patients With Best Overall Tumor Response | SD | 5 Participants |
| Cohort 3 | Number of Patients With Best Overall Tumor Response | PR | 1 Participants |
| Total | Number of Patients With Best Overall Tumor Response | SD | 5 Participants |
| Total | Number of Patients With Best Overall Tumor Response | PR | 0 Participants |
| Total | Number of Patients With Best Overall Tumor Response | PD | 1 Participants |
| Total | Number of Patients With Best Overall Tumor Response | CR | 0 Participants |
| Cohort 3 | Number of Patients With Best Overall Tumor Response | PD | 7 Participants |
| Cohort 3 | Number of Patients With Best Overall Tumor Response | CR | 1 Participants |
| Cohort 3 | Number of Patients With Best Overall Tumor Response | PR | 0 Participants |
| Cohort 3 | Number of Patients With Best Overall Tumor Response | SD | 16 Participants |
Secondary
Number of Patients With Human Antichimeric Antibody (HACA) Reactivity To KW2871
Blood samples were collected for the analysis of HACA at baseline, on Days 29, 115, 143, 171, 199, 227, 255, 283, 311, 339, and at the End of Study visit. Measurement of HACA development in plasma was performed with a BIAcore 2000 biosensor (Biacore AB, Uppsala, Sweden), using the BDF TM015 method. HACA positivity was defined as an increase in binding evident in the test channel but not in the control channel, with positivity assigned for values exceeding a uniform test threshold.
Time frame: From baseline through up to 17 months post-baseline
Population: Patients who received initial treatment with HDI and at least 1 infusion of KW2871 and had at least 1 post-baseline plasma sample evaluated for HACA.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 3 | Number of Patients With Human Antichimeric Antibody (HACA) Reactivity To KW2871 | Baseline negative, post-baseline negative | 5 Participants |
| Cohort 3 | Number of Patients With Human Antichimeric Antibody (HACA) Reactivity To KW2871 | Baseline negative, post-baseline positive | 1 Participants |
| Total | Number of Patients With Human Antichimeric Antibody (HACA) Reactivity To KW2871 | Baseline negative, post-baseline negative | 6 Participants |
| Total | Number of Patients With Human Antichimeric Antibody (HACA) Reactivity To KW2871 | Baseline negative, post-baseline positive | 0 Participants |
| Cohort 3 | Number of Patients With Human Antichimeric Antibody (HACA) Reactivity To KW2871 | Baseline negative, post-baseline negative | 16 Participants |
| Cohort 3 | Number of Patients With Human Antichimeric Antibody (HACA) Reactivity To KW2871 | Baseline negative, post-baseline positive | 0 Participants |