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Mk-1200

MK-1200 is an investigational drug currently being studied in clinical trials for patients with advanced solid tumors. This article provides an overview of the ongoing research, including the study’s objectives, eligibility criteria, and potential benefits for patients with certain types of cancer.

Table of Contents

What is MK-1200?

MK-1200, also known as SKB315, is a new investigational drug being developed for the treatment of advanced solid tumors[1]. It is classified as a biological product, which means it is derived from living organisms or contains components of living organisms[1]. The drug is currently undergoing clinical trials to evaluate its safety and effectiveness in patients with specific types of advanced cancers.

What conditions does MK-1200 target?

MK-1200 is being studied for the treatment of advanced solid tumors. Specifically, the clinical trial is focusing on patients with the following types of cancer[1]:

  • Gastric cancer (including cancer of the gastroesophageal junction)
  • Esophageal cancer
  • Biliary tract cancer
  • Pancreatic ductal adenocarcinoma

These cancers are considered advanced when they are unresectable (cannot be removed by surgery) and/or have metastasized (spread to other parts of the body).

Current Clinical Trial Information

MK-1200 is currently being evaluated in a Phase 1/2 clinical trial[1]. This trial is designed to assess both the safety and efficacy of the drug. Here are some key points about the trial:

  • It is an open-label study, which means both the researchers and participants know which treatment is being administered.
  • The trial is divided into two parts: Part 1 and Part 2.
  • The main objective is to evaluate the safety and tolerability of MK-1200 when used alone (monotherapy).
  • Secondary objectives include assessing the drug’s effectiveness in shrinking tumors and its effects on patient survival.

How MK-1200 Works

While the exact mechanism of action is not provided in the available information, we know that MK-1200 is a biological product[1]. Biological drugs often work by targeting specific proteins or processes in cancer cells or by enhancing the body’s immune response against cancer. The ongoing clinical trial will help researchers better understand how MK-1200 works in patients with advanced solid tumors.

Who is eligible for the MK-1200 trial?

The trial has specific inclusion and exclusion criteria. Some key eligibility factors include[1]:

Inclusion Criteria:

  • Confirmed advanced solid tumor of the types mentioned earlier
  • Have received and progressed on 1 or 2 prior lines of therapy
  • Recovered from side effects of previous cancer treatments
  • HIV-positive patients may be eligible if their condition is well-controlled with antiretroviral therapy

Exclusion Criteria:

  • Active severe digestive disease
  • Known active brain metastases
  • Active infections requiring systemic therapy
  • History of hepatitis B or active hepatitis C
  • Recent major surgery or cardiovascular events
  • Uncontrolled diabetes or hypertension
  • Recent anticancer treatments or radiation therapy

Safety and Efficacy Evaluation

The trial is designed to carefully assess both the safety and effectiveness of MK-1200. Key measures include[1]:

Safety Assessments:

  • Dose-limiting toxicities (DLTs): These are side effects severe enough to prevent increasing the dose of the drug.
  • Adverse events (AEs): Any unfavorable medical occurrences during the trial.
  • Number of participants who stop treatment due to side effects.

Efficacy Assessments:

  • Objective response rate (ORR): The proportion of patients whose tumors shrink or disappear after treatment.
  • Duration of response (DOR): How long the tumor response lasts.
  • Progression-free survival (PFS): The time from start of treatment until the cancer progresses or the patient dies.
  • Overall survival (OS): The time from start of treatment until death from any cause.

These outcomes will be assessed by both trial investigators and an independent review committee to ensure accuracy.

How is MK-1200 administered?

MK-1200 is given as an intravenous infusion. This means it is delivered directly into the bloodstream through a vein[1]. The drug comes in the form of a powder that is made into a solution for infusion. The exact dosing schedule and duration of treatment will be determined as part of the clinical trial.

Aspect Details
Drug Name MK-1200
Trial Phase Phase 1/2
Target Conditions Advanced solid tumors (gastric, esophageal, biliary tract, pancreatic ductal adenocarcinoma)
Main Objective Evaluate safety and tolerability of MK-1200 monotherapy
Key Secondary Objectives Assess antitumor activity, pharmacokinetics, objective response rate
Administration Method Intravenous infusion
Key Eligibility Criteria Confirmed advanced solid tumor, progressed on 1-2 prior therapies
Primary Endpoints Number of participants with dose-limiting toxicities, adverse events, and treatment discontinuation due to adverse events
Key Secondary Endpoints Objective response rate, duration of response, progression-free survival, overall survival

FAQ

  • What is MK-1200? MK-1200 is an investigational drug being studied for the treatment of advanced solid tumors, including gastric, esophageal, biliary tract, and pancreatic ductal adenocarcinoma cancers.
  • What is the main goal of the MK-1200 clinical trial? The main goal is to evaluate the safety and tolerability of MK-1200 when used alone (monotherapy) in patients with advanced solid tumors.
  • Who is eligible to participate in the MK-1200 clinical trial? Eligible participants include those with confirmed advanced solid tumors who have received and progressed on 1 or 2 prior lines of therapy. Specific cancer types include gastric, esophageal, biliary tract, and pancreatic ductal adenocarcinoma.
  • How is MK-1200 administered to patients? MK-1200 is administered through intravenous infusion, which means it is given directly into the bloodstream through a vein.
  • What are some of the key outcomes being measured in the MK-1200 trial? Key outcomes include the number of participants experiencing side effects, objective response rate (how well tumors respond to treatment), duration of response, progression-free survival, and overall survival.

Ongoing Clinical Trials on Mk-1200

  • Study on the Safety and Effectiveness of MK-1200 for Patients with Advanced Solid Tumors

    Not recruiting

    1 1 1 1
    Investigated drugs:
    France Italy Poland Spain

Glossary

  • Advanced solid tumor: A cancer that has spread from where it started to other areas of the body and is usually unable to be completely removed with surgery.
  • Monotherapy: Treatment using a single drug or method, rather than a combination of treatments.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • RECIST 1.1: Response Evaluation Criteria In Solid Tumors version 1.1, a standard way to measure how well a cancer patient responds to treatment.
  • Blinded Independent Central Review (BICR): A method where medical experts who don't know the patient's treatment review their test results to determine how well the treatment is working.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives without their cancer getting worse.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Dose-Limiting Toxicity (DLT): Side effects of a drug that are severe enough to prevent increasing the dose or continuing treatment.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease that occurs during the use of a medical treatment, whether or not it is caused by the treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-mk-1200-for-patients-with-advanced-solid-tumors/