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Monoclonal Antibodies

Part 2: MK-1200 Cohort B for Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 36 months

Awards & highlights

Study Summary

This trial aims to test a new drug, MK-1200, as a standalone treatment for patients with advanced stomach, esophageal, biliary tract, or pancreatic cancer who have already tried other

Who is the study for?

This trial is for adults with advanced solid tumors like stomach, esophagus, biliary tract, or pancreatic cancers who've tried all other treatments without success. They should be recovered from previous treatment side effects and have controlled HIV or hepatitis if present.Check my eligibility

What is being tested?

MK-1200 is being tested to see how safe and effective it is for certain advanced cancers. The study has two parts: first finding the highest dose patients can take without serious side effects (MTD), then testing this dose's safety and effectiveness.See study design

What are the potential side effects?

Possible side effects of MK-1200 are not detailed here but typically include reactions at the injection site, nausea which may require antiemetic drugs to manage, fatigue, and potentially others as determined during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants who Discontinue Study Intervention Due to an AE

Number of Participants who Experience One or More Adverse Events (AEs)

Number of Participants who Experience One or More Dose-Limiting Toxicities (DLTs)

Secondary outcome measures

Area under the curve (AUC) of MK-1200

DOR per RECIST 1.1 as Assessed by Investigator

Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR

+7 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 2: MK-1200 Cohort BExperimental Treatment2 Interventions

In Part 2, participants in Cohort B will receive Dose 1 of MK-1200 via IV infusion Q2W until any discontinuation criteria are met.

Group II: Part 2: MK-1200 Cohort AExperimental Treatment2 Interventions

In Part 2, participants in Cohort A will receive either Dose 1 or Dose 2 of MK-1200 via IV infusion Q2W until any discontinuation criteria are met.

Group III: Part 1: MK-1200Experimental Treatment2 Interventions

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,892 Previous Clinical Trials

5,060,842 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,915 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the risks associated with Part 1: MK-1200 when used by individuals?

"According to our assessment at Power, the safety rating for Part 1: MK-1200 is a 2 on a scale of 1 to 3. This Phase 2 trial has some evidence supporting its safety profile but lacks data confirming efficacy."

Answered by AI

What is the total number of participants being recruited for this research endeavor?

"Affirmative. Information on clinicaltrials.gov indicates that this particular clinical trial is actively seeking eligible individuals to participate. The study was initially posted on March 26, 2024, and the most recent update was made on March 12, 2024. Recruitment aims to enroll a total of 304 participants across three designated sites."

Answered by AI

What is the primary objective of conducting this clinical trial?

"The primary aim of this investigation, which is expected to span around 28 days, focuses on the count of participants discontinuing the study due to an adverse event. Additional goals involve assessing the Maximum Concentration (Cmax) of MK-1200, defined as its peak concentration post-administration with blood samples collected at specific time intervals for Cmax determination; calculating the Area under the Curve (AUC) of MK-1200 by measuring its concentration over time through blood sample analysis at specified intervals; and examining Overall Survival (OS), characterized as the duration from randomization until death from any cause."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors

2024. "Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06242691.

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