| Primary | Objective Response Rate (ORR)- Blinded Independent Central Review (BICR) | The percentage of participants who achieved a Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters [SOD] of target lesions) using per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 by BICR was reported. | Full Analysis Set (FAS) which included all participants who received ≥1 dose of study drug | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to ~18 months | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. | | OG001 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001.4(0.0 to 7.7)
- OG0010.0(NA to NA)None of the participants met criteria
|
|
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| Secondary | ORR- Investigator Assessed | The percentage of participants who achieved a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters [SOD] of target lesions) per RECIST, Version 1.1 by investigator was reported. | FAS which included all participants who received ≥1 dose of study drug | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to ~18 months | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. | | OG001 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
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| Secondary | Time to Response (TTR)- BICR | TTR, defined as the time from the start of study treatment to the first documentation of objective tumor response per RECIST, Version 1.1 by BICR was reported. | Responding Analysis Set which included data from participants in the FAS who had measurable disease, who could be evaluated for tumor response with both baseline and on-study tumor evaluations, and who achieved an objective response. | Posted | | Mean | Standard Deviation | Months | | Up to ~30 months | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. | | OG001 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
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| Secondary | Duration of Response (DOR)- BICR | DOR, defined as the interval from the first documentation of objective tumor response to the earlier of the first documentation of disease progression or death from any cause per RECIST, Version 1.1 by BICR was reported. | Responding Analysis Set which included data from participants in the FAS who had measurable disease, who could be evaluated for tumor response with both baseline and on-study tumor evaluations, and who achieved an objective response. | Posted | | Median | 95% Confidence Interval | Months | | Up to ~30 months | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. | | OG001 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
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| Secondary | Progression-free Survival (PFS)- BICR | PFS, defined as the interval from the start of study treatment to the earlier of the first documentation of disease progression or death from any cause per RECIST, Version 1.1 by BICR was reported. | FAS which included all participants who received ≥1 dose of study drug | Posted | | Median | 95% Confidence Interval | Months | | Up to ~30 months | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. | | OG001 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
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| Secondary | Time to Treatment Failure (TTF)- BICR | TTF, defined as the time from the start of study treatment to the earliest of the first documentation of disease progression, the permanent cessation of study drug due to an AE, or death from any cause per RECIST, Version 1.1 by BICR was reported. | FAS which included all participants who received ≥1 dose of study drug | Posted | | Median | 95% Confidence Interval | Months | | Up to ~30 months | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. | | OG001 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | Overall Survival (OS) | OS, defined as the interval from the start of study treatment to death from any cause will be reported. | FAS which included all participants who received ≥1 dose of study drug | Posted | | Median | 95% Confidence Interval | Months | | Up to ~30 months | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. | | OG001 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
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| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | An AE was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The number of participants who experienced an AE was reported. | FAS which included all participants who received ≥1 dose of study drug | Posted | | Count of Participants | | Participants | | Up to ~30 months | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. | | OG001 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
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| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | An AE was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The number of participants who discontinued study treatment due to an AE was reported. | FAS which included all participants who received ≥1 dose of study drug | Posted | | Count of Participants | | Participants | | Up to ~11 months | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. | | OG001 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
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| Secondary | Maximum Plasma Concentration (Cmax) of Zilovertamab Vedotin-Q1/3W Dosing Schedule | Cmax of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | Cmax of Total Antibody-Q1/3W Dosing Schedule | Cmax of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | Cmax of MMAE-Q1/3W Dosing Schedule | Cmax of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | Area Under the Plasma Concentration-time Curve (AUC) 0-504hrs of Zilovertamab Vedotin- Q1/3W Dosing Schedule | AUC0-504hrs of Zilovertamab Vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | | Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | AUC0-504hrs of Total Antibodies-Q1/3W Dosing Schedule | AUC0-504hrs of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | | Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | AUC0-504hrs of MMAE-Q1/3W Dosing Schedule | AUC0-504hrs of MMAE by blood collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q2/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | | Day 1 [(predose; end of infusion (EOI); and 2 and 4 hours after EOI)], Day 8 (168 hr), Day 15 (336 hr), and Cycle 2 Day 1 (predose); each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q1/3W | Participants received IV zilovertamab vedotin 2.5 mg/kg on Day 1 of each repeated 21-day cycle (Q1/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | Cmax of Zilovertamab Vedotin-Q2/3W Dosing Schedule: Day 1 | Cmax of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | Cmax of Total Antibody-Q2/3W Dosing Schedule: Day 1 | Cmax of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | Cmax of MMAE-Q2/3W Dosing Schedule: Day 1 | Cmax of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | Cmax of Zilovertamab Vedotin-Q2/3W Dosing Schedule: Day 8 | Cmax of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Day 8 [(predose; end of infusion (EOI)], Day 15 (168 hr), Cycle 2 Day 1 Predose; each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | Cmax of Total Antibody-Q2/3W Dosing Schedule: Day 8 | Cmax of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Day 8 [(predose; end of infusion (EOI)], Day 15 (168 hr), Cycle 2 Day 1 Predose; each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
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| Secondary | Cmax of MMAE-Q2/3W Dosing Schedule: Day 8 | Cmax of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Day 8 [(predose; end of infusion (EOI)], Day 15 (168 hr), Cycle 2 Day 1 Predose; each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | AUC0-168hrs of Zilovertamab Vedotin -Q2/3W Dosing Schedule: Day 1 | AUC0-168hrs of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | | Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | AUC0-168hrs of Total Antibody-Q2/3W Dosing Schedule: Day 1 | AUC0-168hrs of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that is not conjugated to monomethyl auristatin E (MMAE). Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | | Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | AUC0-168 hr of MMAE-Q2/3W Dosing Schedule: Day 1 | AUC0-168hrs of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose were reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | | Day 1 [(predose; end of infusion (EOI)], Day 8 (predose); each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | AUC168-336hrs of Zilovertamab Vedotin-Q2/3W Dosing Schedule: Day 8 | AUC168-336 hrs of zilovertamab vedotin determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | | Day 8 [(predose; end of infusion (EOI)], Day 15 (168hr), Cycle 2 Day 1 Predose; each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | AUC168-336 Hrs of Total Antibody-Q2/3W Dosing Schedule: Day 8 | AUC168-336hrs of total antibody determined by blood samples collected pre-dose and at designated timepoints post-dose was reported. Total Antibody was defined as total zilovertamab vedotin plus any antibody that was not conjugated to MMAE. Per protocol the Zilovertamab vedotin Q1/3W Dosing Group was not included in this analysis. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | | Day 8 [(predose; end of infusion (EOI)], Day 15 (168hr), Cycle 2 Day 1 Predose; each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
| |
| Secondary | AUC168-336 hr of MMAE-Q2/3W Dosing Schedule: Day 8 | AUC168-336 of MMAE determined by blood samples collected pre-dose and at designated timepoints post-dose will be reported. | Evaluable Analysis Set which included participants in the FAS who had the necessary baseline and on-study measurements to provide interpretable results for specific parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | | Day 8 [(predose; end of infusion (EOI)], Day 15 (168hr), Cycle 2 Day 1 Predose; each cycle=21 days | | | | ID | Title | Description |
|---|
| OG000 | Zilovertamab Vedotin Q2/3W | Participants received IV zilovertamab vedotin 1.75 mg/kg on Day 1 and Day 8 of each repeated 21-day cycle (Q2/3W). Treatment continued until progressive disease or discontinuation. |
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