Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Part 1 Monotherapy: Number of Patients Who Experience a Treatment-emergent Adverse Event (TEAE) |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy, whichever is earlier. |
Up to 3 years |
|
Primary |
Part 1 Combination Therapy: Number of Patients Who Experience a Treatment-emergent Adverse Event (TEAE) |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy, whichever is earlier. |
Up to 3 years |
|
Primary |
Part 2 Combination Therapy: Number of Patients Who Experience a Treatment-emergent Adverse Event (TEAE) |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE that occurs or worsens in the period extending from the first dose of study drug to 30 days after the last dose of study drug in this study or start of a new anticancer therapy, whichever is earlier. |
Up to 3 years |
|
Primary |
Part 1 Monotherapy: Number of Patients Who Experience a Treatment-emergent Adverse Event (TEAE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above |
AEs will be graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5, where 1 is asymptomatic or mild symptoms and 5 is death related to an AE. |
Up to 3 years |
|
Primary |
Part 1 Combination Therapy: Number of Patients Who Experience a Treatment-emergent Adverse Event (TEAE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above |
AEs will be graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5, where 1 is asymptomatic or mild symptoms and 5 is death related to an AE. |
Up to 3 years |
|
Primary |
Part 2 Combination Therapy: Number of Patients Who Experience a Treatment-emergent Adverse Event (TEAE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above |
AEs will be graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5, where 1 is asymptomatic or mild symptoms and 5 is death related to an AE. |
Up to 3 years |
|
Primary |
Part 1 Monotherapy: Number of Patients Who Experience a Serious Adverse Event (SAE) |
A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization of prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above. |
Up to 3 years |
|
Primary |
Part 1 Combination Therapy: Number of Patients Who Experience a Serious Adverse Event (SAE) |
A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization of prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above. |
Up to 3 years |
|
Primary |
Part 2 Combination Therapy: Number of Patients Who Experience a Serious Adverse Event (SAE) |
A SAE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization of prolongation of existing hospitalization (hospitalization for elective procedures or for protocol compliance is not considered an SAE), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgement may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above. |
Up to 3 years |
|
Primary |
Part 1 Monotherapy: Number of Patients with a Serious Adverse Event (SAE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above |
AEs will be graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5, where 1 is asymptomatic or mild symptoms and 5 is death related to an AE. |
Up to 3 years |
|
Primary |
Part 1 Combination Therapy: Number of Patients with a Serious Adverse Event (SAE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above |
AEs will be graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5, where 1 is asymptomatic or mild symptoms and 5 is death related to an AE. |
Up to 3 years |
|
Primary |
Part 2 Combination Therapy: Number of Patients with a Serious Adverse Event (SAE) of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Above |
AEs will be graded according to CTCAE v4.0 (or more recent). For events not included in the CTCAE criteria, the severity of the AE will be graded on a scale of 1 to 5, where 1 is asymptomatic or mild symptoms and 5 is death related to an AE. |
Up to 3 years |
|
Primary |
Part 1 Monotherapy: Number of Patients who Experience a Clinically Significant Change from Baseline in Laboratory Values |
|
Baseline to up to 3 years |
|
Primary |
Part 1 Combination Therapy: Number of Patients who Experience a Clinically Significant Change from Baseline in Laboratory Values |
|
Baseline to up to 3 years |
|
Primary |
Part 2 Combination Therapy: Number of Patients who Experience a Clinically Significant Change from Baseline in Laboratory Values |
|
Baseline to up to 3 years |
|
Primary |
Part 1 Monotherapy: Number of Patients who Experience a Clinically Significant Change from Baseline in Vital Signs |
|
Baseline to up to 3 years |
|
Primary |
Part 1 Combination Therapy: Number of Patients who Experience a Clinically Significant Change from Baseline in Vital Signs |
|
Baseline to up to 3 years |
|
Primary |
Part 2 Combination Therapy: Number of Patients who Experience a Clinically Significant Change from Baseline in Vital Signs |
|
Baseline to up to 3 years |
|
Primary |
Part 1 Monotherapy: Number of Patients who Experience a Clinically Significant Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status |
|
Baseline to up to 3 years |
|
Primary |
Part 1 Combination Therapy: Number of Patients who Experience a Clinically Significant Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status |
|
Baseline to up to 3 years |
|
Primary |
Part 2 Combination Therapy: Number of Patients who Experience a Clinically Significant Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status |
|
Baseline to up to 3 years |
|
Primary |
Part 1 Monotherapy: Number of Patients who Experience a Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs) |
|
Baseline to up to 3 years |
|
Primary |
Part 1 Combination Therapy: Number of Patients who Experience a Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs) |
|
Baseline to up to 3 years |
|
Primary |
Part 2 Combination Therapy: Number of Patients who Experience a Clinically Significant Change from Baseline in 12-lead Electrocardiograms (ECGs) |
|
Baseline to up to 3 years |
|
Primary |
Part 1 Monotherapy: Number of Patients who Experience a Dose Interruption |
|
Up to 3 years |
|
Primary |
Part 1 Combination Therapy: Number of Patients who Experience a Dose Interruption |
|
Up to 3 years |
|
Primary |
Part 2 Combination Therapy: Number of Patients who Experience a Dose Interruption |
|
Up to 3 years |
|
Primary |
Part 1 Monotherapy: Number of Patients who Experience a Dose Reduction |
|
Up to 3 years |
|
Primary |
Part 1 Combination Therapy: Number of Patients who Experience a Dose Reduction |
|
Up to 3 years |
|
Primary |
Part 2 Combination Therapy: Number of Patients who Experience a Dose Reduction |
|
Up to 3 years |
|
Primary |
Part 1 Monotherapy: Number of Patients who Experience a Dose Limiting Toxicity (DLT) |
|
Day 1 to Day 21 |
|
Primary |
Part 1 Combination Therapy: Number of Patients who Experience a Dose Limiting Toxicity (DLT) |
|
Day 1 to Day 21 |
|
Secondary |
Part 1 Monotherapy: Overall Response Rate (ORR) |
ORR assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. |
Up to 3 years |
|
Secondary |
Part 1 Combination Therapy: Overall Response Rate (ORR) |
ORR assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. |
Up to 3 years |
|
Secondary |
Part 2 Combination Therapy: Overall Response Rate (ORR) |
ORR assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. |
Up to 3 years |
|
Secondary |
Part 1 Monotherapy: Duration of Response (DOR) |
DOR is defined as the time from the first documentation of tumor response to disease progression as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. |
Up to 3 years |
|
Secondary |
Part 1 Combination Therapy: Duration of Response (DOR) |
DOR is defined as the time from the first documentation of tumor response to disease progression as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. |
Up to 3 years |
|
Secondary |
Part 2 Combination Therapy: Duration of Response (DOR) |
DOR is defined as the time from the first documentation of tumor response to disease progression as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. |
Up to 3 years |
|
Secondary |
Part 1 Monotherapy: Progression-free survival (PFS) |
PFS is defined as the time between start of treatment and the first documentation of recurrence or progression as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. |
Up to 3 years |
|
Secondary |
Part 1 Combination Therapy: Progression-free survival (PFS) |
PFS is defined as the time between start of treatment and the first documentation of recurrence or progression as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. |
Up to 3 years |
|
Secondary |
Part 2 Combination Therapy: Progression-free survival (PFS) |
PFS is defined as the time between start of treatment and the first documentation of recurrence or progression as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. |
Up to 3 years |
|
Secondary |
Part 1 Monotherapy: Overall Survival (OS) |
OS is defined as the time between the start of treatment and death from any cause. |
Up to 3 years |
|
Secondary |
Part 1 Combination Therapy: Overall Survival (OS) |
OS is defined as the time between the start of treatment and death from any cause. |
Up to 3 years |
|
Secondary |
Part 2 Combination Therapy: Overall Survival (OS) |
OS is defined as the time between the start of treatment and death from any cause. |
Up to 3 years |
|
Secondary |
Part 1 Monotherapy: Maximum Concentration (Cmax) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Combination Therapy: Maximum Concentration (Cmax) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 2 Combination Therapy: Maximum Concentration (Cmax) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Monotherapy: Time to Maximum Concentration (Tmax) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Combination Therapy: Time to Maximum Concentration (Tmax) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 2 Combination Therapy: Time to Maximum Concentration (Tmax) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Monotherapy: Area Under the Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUC0-last) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUC0-last) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 2 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUC0-last) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Monotherapy: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-8) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-8) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 2 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-8) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Monotherapy: Area Under the Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUC0-t) Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUC0-t) Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 2 Combination Therapy: Area Under the Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUC0-t) Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Monotherapy: Accumulation Index (AI) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Combination Therapy: Accumulation Index (AI) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 2 Combination Therapy: Accumulation Index (AI) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Monotherapy: Clearance (CL) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Combination Therapy: Clearance (CL) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 2 Combination Therapy: Clearance (CL) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Monotherapy: Volume of Distribution (Vd) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Combination Therapy: Volume of Distribution (Vd) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 2 Combination Therapy: Volume of Distribution (Vd) of Camidanlumab Tesirine in Serum |
Total antibody, PBD-conjugated antibody, and unconjugated warhead SG3199 will be measured. |
Up to 3 years |
|
Secondary |
Part 1 Monotherapy: Number of Patients with Confirmed Positive Anti-drug Antibody (ADA) Responses |
ADA titers if applicable, neutralizing activity to camidanlumab tesirine after treatment with camidanlumab tesirine. |
Up to 3 years |
|
Secondary |
Part 1 Combination Therapy: Number of Patients with Confirmed Positive Anti-drug Antibody (ADA) Responses |
ADA titers if applicable, neutralizing activity to camidanlumab tesirine after treatment with camidanlumab tesirine. |
Up to 3 years |
|
Secondary |
Part 2 Combination Therapy: Number of Patients with Confirmed Positive Anti-drug Antibody (ADA) Responses |
ADA titers if applicable, neutralizing activity to camidanlumab tesirine after treatment with camidanlumab tesirine. |
Up to 3 years |
|