MK-1200 for Solid Tumors

No longer recruiting at 16 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Corticosteroids, Anticancer agents

Disqualifiers: Severe digestive disease, Uncontrolled diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 15 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MK-1200, an experimental drug for certain advanced cancers, including those of the stomach, esophagus, bile duct, and pancreas. The trial aims to determine the best dose and assess the safety and effectiveness of MK-1200 when previous treatments have failed or were intolerable. Participants will receive MK-1200 through an IV every two weeks. Suitable candidates have an advanced solid tumor in one of these areas and have already tried one or two other treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received prior systemic anticancer therapy within 4 weeks before the study, which might imply a need to stop certain treatments. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that MK-1200 is likely to be safe for humans?

Research shows that specific safety information for MK-1200 is not yet available. The study remains in its early stages, providing limited knowledge about individual reactions. This phase aims to determine the correct dose and monitor for side effects. Although similar treatments have been studied, they may not cause the same reactions. Participants in these studies receive close monitoring to detect any side effects early. Prospective participants should discuss any concerns with the trial team before joining. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MK-1200 for solid tumors because it offers a novel approach compared to standard treatments like chemotherapy, targeted therapy, or immunotherapy. Unlike traditional therapies, MK-1200 is designed to be administered via intravenous infusion every two weeks, potentially offering a more consistent delivery of the medication. Additionally, MK-1200 may introduce a new mechanism of action, which could target tumor cells more effectively or with fewer side effects. This innovative approach has the potential to improve patient outcomes and provide new hope for those with solid tumors.

What evidence suggests that MK-1200 might be an effective treatment for advanced/metastatic gastric, GEJ, esophageal, biliary tract, and pancreatic ductal adenocarcinoma?

Research has shown that MK-1200 is a promising new treatment for advanced solid tumors, such as stomach, esophagus, bile duct, and pancreatic cancers. In early studies, MK-1200 effectively targeted specific parts of cancer cells that aid their growth. This approach aims to slow or stop the cancer from spreading. Although detailed results in humans remain limited, the targeted nature of MK-1200 has shown initial promise in research settings. Participants in this trial will receive MK-1200 in different cohorts to evaluate its effectiveness and safety. As more information becomes available, researchers hope to confirm its benefits for people with these difficult-to-treat cancers. ^{1 2 5 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have recovered from side effects of previous cancer treatments.

My cancer is advanced and cannot be removed by surgery.

My HIV is well controlled with medication.

Exclusion Criteria

I have a severe digestive condition.

I have a history of serious heart diseases.

Cardiac pacemaker use

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of MK-1200 via IV infusion every 2 weeks to determine the maximum tolerated dose (MTD)

Up to 28 days

Bi-weekly visits (in-person)

Treatment

Participants receive MK-1200 at determined doses via IV infusion every 2 weeks

Up to 15 months

Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-1200

Trial Overview 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.

How Is the Trial Designed?

Group I: Part 2: MK-1200 Cohort B Experimental Treatment 2 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 A Experimental Treatment 2 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-1200 Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

The maximum-tolerated dose (MTD) of CKD-516, a new vascular disrupting agent, was established at 12 mg/m²/day, with safety evaluations revealing manageable side effects primarily related to gastrointestinal issues and hypertension.

In a study of 23 patients with advanced solid tumors, CKD-516 demonstrated preliminary antitumor efficacy, with 26.1% of patients achieving stable disease and a median progression-free survival of 39 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I Study of CKD-516, a Novel Vascular Disrupting Agent, in Patients with Advanced Solid Tumors. Oh, DY., Kim, TM., Han, SW., et al.[2018]

MK-0888, a VEGFR-2 inhibitor, was generally well tolerated in both healthy volunteers and cancer patients at doses up to 100 mg, indicating a favorable early safety profile.

However, the pharmacokinetic analysis revealed that MK-0888 did not achieve the necessary drug levels for efficacy, suggesting that further development of this compound may not be warranted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic/pharmacodynamic-based decision making in the development of MK-0888, a VEGFR-2/FLT-3 kinase inhibitor. Iwamoto, M., Friedman, EJ., Sepp-Lorenzino, L., et al.[2015]

In a phase II study involving 14 patients with advanced uterine serous carcinoma (USC), the AKT inhibitor MK-2206 showed limited efficacy, with a clinical benefit rate of 14.3% and a median progression-free survival of only 2 months.

Despite the overall limited activity, one patient achieved a partial response and remained progression-free for 6 months, suggesting that some patients may benefit from this treatment, warranting further research to identify responsive patient characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of MK-2206, an AKT inhibitor, in uterine serous carcinoma. Stover, EH., Xiong, N., Myers, AP., et al.[2022]

The maximum-tolerated dose (MTD) of MK-0457, a novel pan-Aurora kinase inhibitor, was determined to be 64 mg/m²/h, with dose-limiting toxicities including severe neutropenia and herpes zoster observed at higher doses.

MK-0457 was generally well tolerated, with nearly half of the 27 patients experiencing stable disease, suggesting potential efficacy, particularly in combination with other cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I dose escalation study of MK-0457, a novel Aurora kinase inhibitor, in adult patients with advanced solid tumors. Traynor, AM., Hewitt, M., Liu, G., et al.[2022]

In a study involving 20 Japanese patients with advanced colorectal cancer, the combination of MK-0646 with cetuximab and irinotecan was found to be well tolerated, with only one patient experiencing a dose-limiting toxicity (grade 3 hyperglycemia).

The combination therapy increased the exposure of MK-0646 by 25% without affecting the pharmacokinetics of cetuximab and irinotecan, although it did reduce the levels of SN-38, the active metabolite of irinotecan, indicating minimal drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 pharmacokinetic study of MK-0646 (dalotuzumab), an anti-insulin-like growth factor-1 receptor monoclonal antibody, in combination with cetuximab and irinotecan in Japanese patients with advanced colorectal cancer. Doi, T., Muro, K., Yoshino, T., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06242691

Safety and Efficacy of MK-1200 in Participants With ... The purpose of this study is to assess the efficacy and safety of MK-1200 monotherapy in participants with advanced/metastatic gastric/gastroesophageal ...

2. trialx.com trialx.com/clinical-trials/listings/286381/safety-and-efficacy-of-mk-1200-in-participants-with-advanced-solid-tumors/

Safety and Efficacy of MK-1200 in Participants With ... Overview. The purpose of this study is to assess the efficacy and safety of MK-1200 monotherapy in participants with advanced/metastatic ...

3. clinicaltrials.eu clinicaltrials.eu/inn/mk-1200/

MK-1200: A Promising Treatment for Advanced Solid Tumors MK-1200 is an investigational drug being studied for the treatment of advanced solid tumors, including gastric, esophageal, biliary tract, and pancreatic ductal ...

4. withpower.com withpower.com/trial/phase-2-neoplasms-2-2024-bed4a

MK-1200 for Solid Tumors · Info for Participants The purpose of this study is to assess the efficacy and safety of MK-1200 monotherapy in participants with advanced/metastatic gastric/gastroesophageal ...

5. trialstransparency.merckclinicaltrials.com trialstransparency.merckclinicaltrials.com/Upload/1144_D1_PPLS_2023-508684-68_for%20pub_14Jun2024_V3.0_MK-1200-002-04.pdf

A clinical study of MK-1200 to treat advanced solid tumors (MK ... MK-1200, the study medicine, is designed to treat advanced solid tumors. MK-1200 is a type of targeted therapy.

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

Study on the Safety and Effectiveness of MK-1200 for ... The results of the study will contribute to understanding the safety and efficacy of MK-1200 for treating advanced solid tumors.

7. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-03209

Safety and Efficacy of MK-1200 in Participants ... The purpose of this study is to assess the efficacy and safety of MK-1200 monotherapy in participants with advanced/metastatic gastric/gastroesophageal ...