Advanced Solid TumorsPhase 1/2NCT06242691
Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002)
A Phase 1/2 study testing MK-1200 and Antiemetic in people with Advanced Solid Tumors, run by Merck Sharp & Dohme LLC at 16 sites in 6 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- MK-1200 and Antiemetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 16 sitesin 6 countries
- Study dates
- 28 Feb 2024to 17 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed advanced (unresectable and/or metastatic) solid tumor: gastric cancer (including gastroesophageal junction cancer), esophageal cancer, biliary tract cancer, or pancreatic ductal adenocarcinoma
- Participants who experienced Adverse Events (AEs) due to previous anticancer therapies must have recovered to < Grade 1 or baseline
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
- Participants with a history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable
- Received and progressed on or after 1 or 2 prior lines of therapy
Who cannot join
- Active severe digestive disease
- History of acute myocardial infarction; unstable angina; stroke or transient ischemic attack within 6 months prior to the first dose of study intervention
- Diabetes or hypertension that cannot be controlled by medication
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before study intervention
- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
Show all 10Show fewer
- Known additional malignancy that is progressing or has required active treatment within the past 2 years
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active infection requiring systemic therapy
- Have not adequately recovered from major surgery or have ongoing surgical complications
Trial locations and contacts
16 sites in 6 countries.
16 sites in 6 countries
United States5 sites
University of Virginia Health System-Hematology-Oncology ( Site 0009)
Charlottesville, Virginia, 22908
START Midwest ( Site 0014)
Grand Rapids, Michigan, 49546
The University of Louisville, James Graham Brown Cancer Center ( Site 0004)
Louisville, Kentucky, 40202
South Texas Accelerated Research Therapeutics (START) ( Site 0005)
San Antonio, Texas, 78229
START Mountain Region ( Site 0015)
West Valley City, Utah, 84119
Israel5 sites
Rambam Health Care Campus-Oncology Division ( Site 0602)
Haifa, 3109601
Hadassah Medical Center ( Site 0604)
Jerusalem, 9112001
Rabin Medical Center-Oncology ( Site 0603)
Petah Tikva, 4941492
Sheba Medical Center ( Site 0605)
Ramat Gan, 5265601
Sourasky Medical Center ( Site 0601)
Tel Aviv, 6423906
China3 sites
Beijing Cancer hospital-Digestive Oncology ( Site 0401)
Beijing, Beijing Municipality, 100142
Fujian Cancer Hospital-oncology department ( Site 0409)
Fuzhou, Fujian, 350000
First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0415)
Huai'an, Jiangsu, 223300
Chile1 site
Bradfordhill-Clinical Area ( Site 0301)
Santiago, Region M. de Santiago, 8420383
South Korea1 site
Samsung Medical Center-Division of Hematology/Oncology ( Site 1003)
Seoul, 06351
About this study
Official title: A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors
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
- Conditions
- Advanced Solid Tumors
- Being tested
- MK-1200, Antiemetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-1200Biological
IV Infusion
AntiemeticDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: MK-1200; Drug: Antiemetic |
| 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. Receives: Biological: MK-1200; Drug: Antiemetic |
| 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. Receives: Biological: MK-1200; Drug: Antiemetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Grade 4 nonhematologic toxicity (not laboratory). Any nonhematologic AE ≥Grade 3 in severity was considered a DLT, with pre-specified exceptions
- Any Grade 3 or Grade 4 laboratory value (hematologic or nonhematologic), with pre-specified exceptions
- Febrile neutropenia Grade 3 or Grade 4 as prespecified by the protocol
- Prolonged delay (>2 weeks) in initiating Cycle 2 due to intervention-related toxicity
- Any intervention-related toxicity that caused the participant to discontinue intervention during Cycle 1
- Missed >25% of MK-1200 doses as a result of drug-related AEs during the first cycle
- Grade 5 toxicity
Measured: 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.
Measured: 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.
Measured: Up to approximately 9 months
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start28 Feb 2024
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242691
- Sponsor's protocol ID
- 1200-002
- Other IDs
- 2023-508684-68-00, U1111-1298-7820, MK-1200-002, 2023
- Status last verified
- May 2026
- First submitted
- 26 Jan 2024
- Last updated
- 5 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06242691
- Acronym / sponsor ID
- 1200-002
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Posted 5 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: MK-1200 | Experimental | Biological: MK-1200, Drug: AntiemeticIn Part 1, participants will receive escalating doses of MK-1200 via intravenous (IV) infusion every 2 weeks (Q2W) until any discontinuation criteria are met. |
| Part 2: MK-1200 Cohort A | Experimental | Biological: MK-1200, Drug: AntiemeticIn 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. |
| Part 2: MK-1200 Cohort B | Experimental | Biological: MK-1200, Drug: AntiemeticIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed advanced (unresectable and/or metastatic) solid tumor: gastric cancer (including gastroesophageal junction cancer), esophageal cancer, biliary tract cancer, or pancreatic ductal adenocarcinoma
- Participants who experienced Adverse Events (AEs) due to previous anticancer therapies must have recovered to < Grade 1 or baseline
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
- Participants with a history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable
Key exclusion criteria (10 listed)
- Active severe digestive disease
- History of acute myocardial infarction; unstable angina; stroke or transient ischemic attack within 6 months prior to the first dose of study intervention
- Diabetes or hypertension that cannot be controlled by medication
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before study intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-1200IV Infusion | Biological | Part 1: MK-1200, Part 2: MK-1200 Cohort A, Part 2: MK-1200 Cohort B |
| AntiemeticOne 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 | Drug | Part 1: MK-1200, Part 2: MK-1200 Cohort A, Part 2: MK-1200 Cohort B |
Primary outcome
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Part 1
Time frame: During the first two 14-day cycles (Up to approximately 28 days)
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: * Grade 4 nonhematologic toxicity (not laboratory). Any nonhematologic AE ≥Grade 3 in severity was considered a DLT, with pre-specified exceptions * Any Grade 3 or Grade 4 laboratory value (hematologic or nonhematologic), with pre-specified exceptions * Febrile neutropenia Grade 3 or Grade 4 as prespecified by the protocol * Prolonged delay (>2 weeks) in initiating Cycle 2 due to intervention-related toxicity * Any intervention-related toxicity that caused the participant to discontinue intervention during Cycle 1 * Missed >25% of MK-1200 doses as a result of drug-related AEs during the first cycle * Grade 5 toxicity
Number of Participants Who Experience One or More Adverse Events (AEs) - Part 1 & Part 2
Time frame: Up to approximately 12 months
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.
Number of Participants Who Discontinue Study Intervention Due to an AE - Part 1 & Part 2
Time frame: Up to approximately 9 months
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.
15 secondary outcomes
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
Time frame: Up to approximately 13 months
ORR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to approximately 13 months
DOR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
Time frame: Up to approximately 13 months
Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A
Time frame: Up to approximately 13 months
PFS Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
Time frame: Up to approximately 13 months
Overall Survival (OS) - Part 1 & Part 2
Time frame: Up to approximately 13 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
16 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MK-1200 and Antiemetic in people with Advanced Solid Tumors, run by Merck Sharp & Dohme LLC at 16 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Israel, China, Australia, Chile and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Part 1 (time frame: During the first two 14-day cycles (Up to approximately 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.