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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508684-68-00 | Registry Identifier | EU CT | |
| U1111-1298-7820 | Registry Identifier | UTN | |
| MK-1200-002 | Other Identifier | MSD |
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The purpose of this study is to assess the efficacy and safety of MK-1200 monotherapy in participants with advanced/metastatic gastric/gastroesophageal junction (GEJ) cancer, esophageal cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma who have received, or been intolerant to, all treatments known to confer clinical benefit. Part 1 of the study will be a dose escalation to determine the maximum tolerated dose (MTD). Part 2 will evaluate safety and efficacy of MK-1200 at 2 different doses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: MK-1200 | Experimental | In Part 1, participants will receive escalating doses of MK-1200 via intravenous (IV) infusion every 2 weeks (Q2W) until any discontinuation criteria are met. |
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| Part 2: MK-1200 Cohort A | Experimental | In Part 2, participants in Cohort A will receive either Dose 1 or Dose 2 of MK-1200 (determined from Part 1) via IV infusion Q2W until any discontinuation criteria are met. |
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| Part 2: MK-1200 Cohort B | Experimental | In Part 2, participants in Cohort B will receive Dose 1 of MK-1200 (determined from Part 1) via IV infusion Q2W until any discontinuation criteria are met. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1200 | Biological | IV Infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Part 1 | The occurrence of any of the following toxicities within 28 days after the first dose of study intervention were considered a DLT, if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration:
| During the first two 14-day cycles (Up to approximately 28 days) |
| Number of Participants Who Experience One or More Adverse Events (AEs) - Part 1 & Part 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an AE is reported for each arm. | Up to approximately 12 months |
| Number of Participants Who Discontinue Study Intervention Due to an AE - Part 1 & Part 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study intervention due to an AE is reported for each arm. | Up to approximately 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) - Part 2 Cohort A | ORR was defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by blinded independent central review (BICR). As pre-specified by the protocol, this analysis was to only include all participants randomized to Part 2 Cohort A who received at least 1 dose of study intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Louisville, James Graham Brown Cancer Center ( Site 0004) | Louisville | Kentucky | 40202 | United States | ||
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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In Part 1, a total of 13 participants received the following doses: 3.6 mg/kg (3 participants), 4.2 mg/kg (5 participants), and 4.8 mg/kg (5 participants). Part 2 was not initiated and no patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: MK-1200 3.6 mg/kg | In Part 1, participants received 3.6 mg/kg of MK-1200 via IV infusion every 2 weeks (q2w) until any discontinuation criteria were met. |
| FG001 | Part 1: MK-1200 4.2 mg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2024 |
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| Antiemetic | Drug | One or more prophylactic antiemetic(s) (e.g. 5-HT3 receptor antagonists, dexamethasone, neurokinin-1 receptor antagonists, etc.) may be selected based on previous response of participants to antiemetic medications and individual factors, and will be administered per approved product label prior to MK-1200 infusion |
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| Up to approximately 13 months |
| ORR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B | ORR was defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator. | Up to approximately 13 months |
| Area Under the Concentration Versus Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-1200-Antibody-Drug Conjugate (ADC) - Parts 1 and 2 | AUC0-336 was defined as the area under the concentration versus time curve of MK-1200-ADC from time 0 to 336 Hours. Blood samples were collected at pre-specified timepoints to determine the AUC0-336 of the MK-1200-ADC. | Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
| AUC0-336 of the Conjugated Toxin Payload (KL610023) - Parts 1 and 2 | AUC0-336 was defined as the area under the concentration versus time curve of KL610023 from time 0 to 336 Hours. Blood samples were collected at pre-specified timepoints to determine AUC0-336 of KL610023. | Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
| Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of MK-1200-ADC - Parts 1 and 2 | AUC0-tau was defined as the area under the concentration versus time curve of MK-1200-ADC from time 0 to the end of the 14-day dosing period (Cycle 4, 336 hours post-dose). Blood samples were collected at pre-specified timepoints to determine AUC0-tau of the MK-1200-ADC. | Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
| AUC0-tau of KL610023 - Parts 1 and 2 | AUC0-tau is defined as the area under the concentration versus time curve of KL610023 from time 0 to the end of the 14-day dosing period (Cycle 4, 336 hours post-dose). Blood samples were collected at pre-specified timepoints to determine AUC0-tau of KL610023. | Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
| Minimum Concentration (Cmin) of MK-1200-ADC - Part 1 & Part 2 | Cmin was defined as the minimum concentration of MK-1200-ADC observed in plasma after its administration and just prior to administration of a subsequent dose. Blood samples were collected at pre-specified timepoints to determine Cmin of the MK-1200-ADC. | Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
| Cmin of KL610023 - Part 1 & Part 2 | Cmin was defined as the minimum concentration of KL610023 observed in plasma after its administration and just prior to administration of a subsequent dose. Blood samples were collected at pre-specified timepoints to determine Cmin of KL610023. | Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
| Maximum Concentration (Cmax) of MK-1200-ADC - Part 1 & Part 2 | Cmax was defined as the maximum or 'peak' concentration of MK-1200-ADC observed after its administration. Blood samples were collected at pre-specified timepoints to determine Cmax of the MK-1200-ADC. | Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
| Cmax of KL610023 - Part 1 & Part 2 | Cmax was defined as the maximum or 'peak' concentration of KL610023 observed after its administration. Blood samples were collected at pre-specified timepoints to determine Cmax of KL610023. | Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A | For participants demonstrating a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from the first documented evidence of a CR or a PR until Progressive Disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. As pre-specified by the protocol, DOR for Part 2 Cohort A was planned to be assessed by BICR and was to include all participants randomized to Part 2 Cohort A who received at least one dose of study intervention. | Up to approximately 13 months |
| DOR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B | For participants demonstrating a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from the first documented evidence of a CR or a PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by the investigator is reported. | Up to approximately 13 months |
| Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A | PFS was defined as the time from randomization to the first documented PD by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. As pre-specified by the protocol, PFS for Part 2 Cohort A was planned to be assessed by BICR and was to only include all participants randomized to Part 2 Cohort A who received at least one dose of study intervention. | Up to approximately 13 months |
| PFS Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B | PFS was defined as the time from randomization to the first documented PD by investigator or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by the investigator is reported. | Up to approximately 13 months |
| Overall Survival (OS) - Part 1 & Part 2 | OS was defined as the time from randomization to death due to any cause. | Up to approximately 13 months |
| START Midwest ( Site 0014) |
| Grand Rapids |
| Michigan |
| 49546 |
| United States |
| South Texas Accelerated Research Therapeutics (START) ( Site 0005) | San Antonio | Texas | 78229 | United States |
| START Mountain Region ( Site 0015) | West Valley City | Utah | 84119 | United States |
| University of Virginia Health System-Hematology-Oncology ( Site 0009) | Charlottesville | Virginia | 22908 | United States |
| The Alfred Hospital ( Site 0103) | Melbourne | Victoria | 3004 | Australia |
| Bradfordhill-Clinical Area ( Site 0301) | Santiago | Region M. de Santiago | 8420383 | Chile |
| Beijing Cancer hospital-Digestive Oncology ( Site 0401) | Beijing | Beijing Municipality | 100142 | China |
| Fujian Cancer Hospital-oncology department ( Site 0409) | Fuzhou | Fujian | 350000 | China |
| First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0415) | Huai'an | Jiangsu | 223300 | China |
| Rambam Health Care Campus-Oncology Division ( Site 0602) | Haifa | 3109601 | Israel |
| Hadassah Medical Center ( Site 0604) | Jerusalem | 9112001 | Israel |
| Rabin Medical Center-Oncology ( Site 0603) | Petah Tikva | 4941492 | Israel |
| Sheba Medical Center ( Site 0605) | Ramat Gan | 5265601 | Israel |
| Sourasky Medical Center ( Site 0601) | Tel Aviv | 6423906 | Israel |
| Samsung Medical Center-Division of Hematology/Oncology ( Site 1003) | Seoul | 06351 | South Korea |
In Part 1, participants received 4.2 mg/kg of MK-1200 via IV infusion q2w until any discontinuation criteria were met.
| FG002 | Part 1: MK-1200 4.8 mg/kg | In Part 1, participants received 4.8 mg/kg of MK-1200 via IV infusion q2w until any discontinuation criteria were met. |
| FG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| FG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
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| NOT COMPLETED |
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Baseline characteristics include data from 13 participants allocated to Part 1. No participants were enrolled in Part 2; therefore, no baseline characteristics data are reported for Part 2.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: MK-1200 3.6 mg/kg | In Part 1, participants received 3.6 mg/kg of MK-1200 via IV infusion every 2 weeks (q2w) until any discontinuation criteria were met. |
| BG001 | Part 1: MK-1200 4.2 mg/kg | In Part 1, participants received 4.2 mg/kg of MK-1200 via IV infusion q2w until any discontinuation criteria were met. |
| BG002 | Part 1: MK-1200 4.8 mg/kg | In Part 1, participants received 4.8 mg/kg of MK-1200 via IV infusion q2w until any discontinuation criteria were met. |
| BG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| BG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
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| Primary | Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Part 1 | The occurrence of any of the following toxicities within 28 days after the first dose of study intervention were considered a DLT, if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration:
| All randomized participants in Part 1 who received at least one dose of study intervention and met the criteria for DLT evaluability (participants in Part 1 who completed Cycle 1 without a DLT or experienced a DLT during Cycle 1). One participant withdrew consent during the DLT evaluation period and was excluded from DLT analysis. | Posted | Count of Participants | Participants | During the first two 14-day cycles (Up to approximately 28 days) |
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| Primary | Number of Participants Who Experience One or More Adverse Events (AEs) - Part 1 & Part 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an AE is reported for each arm. | All randomized participants in Part 1 and Part 2 who received at least one dose of study intervention. No participants were enrolled in Part 2; thus, no data were collected or analyzed for Part 2. | Posted | Count of Participants | Participants | Up to approximately 12 months |
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| Primary | Number of Participants Who Discontinue Study Intervention Due to an AE - Part 1 & Part 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study intervention due to an AE is reported for each arm. | All randomized participants in Part 1 and Part 2 who received at least one dose of study intervention. No participants were enrolled in Part 2; thus, no data were collected or analyzed for Part 2. | Posted | Count of Participants | Participants | Up to approximately 9 months |
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| Secondary | Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) - Part 2 Cohort A | ORR was defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by blinded independent central review (BICR). As pre-specified by the protocol, this analysis was to only include all participants randomized to Part 2 Cohort A who received at least 1 dose of study intervention. | As pre-specified by the protocol, this analysis was to only include all participants randomized to Part 2 Cohort A who received at least 1 dose of study intervention. No participants enrolled in Part 2; thus, no data were collected or analyzed. | Posted | Up to approximately 13 months |
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| Secondary | ORR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B | ORR was defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator. | All randomized participants in Part 1 and Part 2 Cohort B who received at least one dose of study intervention. No participants were enrolled in Part 2; thus, no data were collected or analyzed for Part 2. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 13 months |
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| Secondary | Area Under the Concentration Versus Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-1200-Antibody-Drug Conjugate (ADC) - Parts 1 and 2 | AUC0-336 was defined as the area under the concentration versus time curve of MK-1200-ADC from time 0 to 336 Hours. Blood samples were collected at pre-specified timepoints to determine the AUC0-336 of the MK-1200-ADC. | The subset of participants in Part 1 and Part 2 who complied with the protocol and had available data from at least one treatment administration were to be analyzed. No participants were enrolled in Part 2; thus, no data were collected or analyzed for Part 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
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| Secondary | AUC0-336 of the Conjugated Toxin Payload (KL610023) - Parts 1 and 2 | AUC0-336 was defined as the area under the concentration versus time curve of KL610023 from time 0 to 336 Hours. Blood samples were collected at pre-specified timepoints to determine AUC0-336 of KL610023. | The subset of participants in Part 1 and Part 2 who complied with the protocol and had available data from at least one treatment administration were to be analyzed. No participants were enrolled in Part 2; thus, no data were collected or analyzed for Part 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
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| Secondary | Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of MK-1200-ADC - Parts 1 and 2 | AUC0-tau was defined as the area under the concentration versus time curve of MK-1200-ADC from time 0 to the end of the 14-day dosing period (Cycle 4, 336 hours post-dose). Blood samples were collected at pre-specified timepoints to determine AUC0-tau of the MK-1200-ADC. | The subset of participants in Part 1 and Part 2 who complied with the protocol and had available data from at least one treatment administration were to be analyzed. No participants were enrolled in Part 2; thus, no data were collected or analyzed for Part 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*μg/mL | Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
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| Secondary | AUC0-tau of KL610023 - Parts 1 and 2 | AUC0-tau is defined as the area under the concentration versus time curve of KL610023 from time 0 to the end of the 14-day dosing period (Cycle 4, 336 hours post-dose). Blood samples were collected at pre-specified timepoints to determine AUC0-tau of KL610023. | The subset of participants in Part 1 and Part 2 who complied with the protocol and had available data from at least one treatment administration were to be analyzed. No participants were enrolled in Part 2; thus, no data were collected or analyzed for Part 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
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| Secondary | Minimum Concentration (Cmin) of MK-1200-ADC - Part 1 & Part 2 | Cmin was defined as the minimum concentration of MK-1200-ADC observed in plasma after its administration and just prior to administration of a subsequent dose. Blood samples were collected at pre-specified timepoints to determine Cmin of the MK-1200-ADC. | The subset of participants in Part 1 and Part 2 who complied with the protocol and had available data from at least one treatment administration were to be analyzed. No participants were enrolled in Part 2; thus, no data were collected or analyzed for Part 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
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| Secondary | Cmin of KL610023 - Part 1 & Part 2 | Cmin was defined as the minimum concentration of KL610023 observed in plasma after its administration and just prior to administration of a subsequent dose. Blood samples were collected at pre-specified timepoints to determine Cmin of KL610023. | The subset of participants in Part 1 and Part 2 who complied with the protocol and had available data from at least one treatment administration were to be analyzed. No participants were enrolled in Part 2; thus, no data were collected or analyzed for Part 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
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| Secondary | Maximum Concentration (Cmax) of MK-1200-ADC - Part 1 & Part 2 | Cmax was defined as the maximum or 'peak' concentration of MK-1200-ADC observed after its administration. Blood samples were collected at pre-specified timepoints to determine Cmax of the MK-1200-ADC. | The subset of participants in Part 1 and Part 2 who complied with the protocol and had available data from at least one treatment administration were to be analyzed. No participants were enrolled in Part 2; thus, no data were collected or analyzed for Part 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
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| Secondary | Cmax of KL610023 - Part 1 & Part 2 | Cmax was defined as the maximum or 'peak' concentration of KL610023 observed after its administration. Blood samples were collected at pre-specified timepoints to determine Cmax of KL610023. | The subset of participants in Part 1 and Part 2 who complied with the protocol and had available data from at least one treatment administration were to be analyzed. No participants were enrolled in Part 2; thus, no data were collected or analyzed for Part 2. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days. |
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| Secondary | Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A | For participants demonstrating a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from the first documented evidence of a CR or a PR until Progressive Disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. As pre-specified by the protocol, DOR for Part 2 Cohort A was planned to be assessed by BICR and was to include all participants randomized to Part 2 Cohort A who received at least one dose of study intervention. | As pre-specified by the protocol, this analysis was to only include all participants randomized to Part 2 Cohort A who received at least 1 dose of study intervention and achieved CR or PR. No participants enrolled in Part 2; thus, no data were collected or analyzed. | Posted | Up to approximately 13 months |
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| Secondary | DOR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B | For participants demonstrating a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from the first documented evidence of a CR or a PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by the investigator is reported. | All randomized participants in Part 1 and Part 2 Cohort B who received at least one dose of study intervention and achieved CR or PR were analyzed. No participants were enrolled in Part 2; thus, no data were collected or analyzed for Part 2. | Posted | Up to approximately 13 months |
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| Secondary | Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A | PFS was defined as the time from randomization to the first documented PD by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. As pre-specified by the protocol, PFS for Part 2 Cohort A was planned to be assessed by BICR and was to only include all participants randomized to Part 2 Cohort A who received at least one dose of study intervention. | As pre-specified by the protocol, this analysis was to only include all participants randomized to Part 2 Cohort A who received at least 1 dose of study intervention. No participants enrolled in Part 2; thus, no data were collected or analyzed. | Posted | Up to approximately 13 months |
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| Secondary | PFS Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B | PFS was defined as the time from randomization to the first documented PD by investigator or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by the investigator is reported. | All randomized participants in Part 1 and Part 2 Cohort B who received at least one dose of study intervention. No participants were enrolled in Part 2; thus, no data were collected or analyzed for Part 2. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 13 months |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - Part 1 & Part 2 | OS was defined as the time from randomization to death due to any cause. | All randomized participants in Part 1 and Part 2 who received at least one dose of study intervention. No participants were enrolled in Part 2; thus, no data were collected or analyzed for Part 2. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 13 months |
|
Up to approximately 13 months
The population for all-cause mortality includes all allocated participants. The population for serious and nonserious AEs includes all participants in Part 1 and Part 2 who received at least one dose of study intervention and were analyzed according to treatment received. No participants were enrolled in Part 2; thus, no data were collected for Part 2.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: MK-1200 3.6 mg/kg | In Part 1, participants received 3.6 mg/kg of MK-1200 via IV infusion every 2 weeks (q2w) until any discontinuation criteria were met. | 2 | 3 | 1 | 3 | 3 | 3 |
| EG001 | Part 1: MK-1200 4.2 mg/kg | In Part 1, participants received 4.2 mg/kg of MK-1200 via IV infusion q2w until any discontinuation criteria were met. | 5 | 5 | 4 | 5 | 5 | 5 |
| EG002 | Part 1: MK-1200 4.8 mg/kg | In Part 1, participants received 4.8 mg/kg of MK-1200 via IV infusion q2w until any discontinuation criteria were met. | 4 | 5 | 0 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 28.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@msd.com |
| Apr 16, 2026 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000932 | Antiemetics |
| ID | Term |
|---|---|
| D001337 | Autonomic Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D005765 | Gastrointestinal Agents |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 |
| Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) |
In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria are met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
|
| OG003 |
| Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) |
In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
|
In Part 1, participants received 4.8 mg/kg of MK-1200 via IV infusion q2w until any discontinuation criteria were met. |
| OG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
| OG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
|
| OG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
|
| OG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
|
In Part 1, participants received 4.8 mg/kg of MK-1200 via IV infusion q2w until any discontinuation criteria were met.
| OG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
|
| OG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
|
| OG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
|
| OG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
|
| OG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
|
| OG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
|
| OG002 | Part 1: MK-1200 4.8 mg/kg | In Part 1, participants received 4.8 mg/kg of MK-1200 via IV infusion q2w until any discontinuation criteria were met. |
| OG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
| Part 1: MK-1200 4.8 mg/kg |
In Part 1, participants received 4.8 mg/kg of MK-1200 via IV infusion q2w until any discontinuation criteria were met. |
| OG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
| Part 1: MK-1200 4.8 mg/kg |
In Part 1, participants received 4.8 mg/kg of MK-1200 via IV infusion q2w until any discontinuation criteria were met. |
| OG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
In Part 1, participants received 4.8 mg/kg of MK-1200 via IV infusion q2w until any discontinuation criteria were met.
| OG003 | Part 2: MK-1200 Cohort A (Part 2-Not Enrolled) | In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
|
In Part 2, participants in Cohort A were to receive either Dose 1 or Dose 2 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm.
| OG004 | Part 2: MK-1200 Cohort B (Part 2-Not Enrolled) | In Part 2, participants in Cohort B were to receive Dose 1 of MK-1200 via IV infusion q2w until any discontinuation criteria were met. No participants were enrolled in this arm. |
|
|
|
|
|
|