200 Participants NeededMy employer runs this trial

MK-2010 + Sacituzumab Tirumotecan for Cancer

Recruiting at 3 trial locations
TF
Overseen ByToll Free Number
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat certain advanced solid tumors, which occur in organs or tissues rather than blood. It examines the combination of two trial drugs, MK-2010 and sacituzumab tirumotecan (sac-TMT), to determine if they can effectively shrink or eliminate tumors together. Researchers aim to assess the safety and efficacy of this combination. Individuals with advanced cancer that hasn't responded to other treatments and who can perform normal daily activities might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant advancements in cancer treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that sacituzumab tirumotecan (sac-TMT) generally has a manageable safety profile. In studies, patients with advanced solid tumors could undergo the treatment without major issues. Some side effects occurred, but they rarely required stopping treatment. Sac-TMT has also been tested with other drugs like pembrolizumab, and patients generally tolerated these combinations well.

There is less information about MK-2010 specifically, but the manageable safety profile of sac-TMT provides some insight into its potential safety when used with MK-2010. This trial is in an early phase, so MK-2010 is still under study for safety, but past results for sac-TMT are promising.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about MK-2010 combined with sacituzumab tirumotecan because this combination targets cancer cells in a unique way. Unlike current treatments that might use chemotherapy to kill rapidly dividing cells indiscriminately, sacituzumab tirumotecan links a cancer-killing agent to an antibody that specifically targets tumor cells, potentially reducing harm to healthy cells. Additionally, MK-2010 is designed to enhance the immune system's ability to fight cancer, offering a dual-action approach that could improve effectiveness and lessen side effects compared to standard treatments. This innovative mechanism of action could mean better outcomes for patients with fewer side effects.

What evidence suggests that this trial's treatments could be effective for advanced solid tumors?

Research has shown that sacituzumab tirumotecan (sac-TMT) may effectively treat certain cancers. Studies have found that sac-TMT can shrink tumors in advanced or metastatic cancers, such as cervical cancer. As an antibody-drug conjugate (ADC), this drug targets cancer cells directly to deliver potent treatment. In this trial, participants will receive MK-2010 combined with sac-TMT. MK-2010 is designed to boost the immune system to help fight cancer. Although limited information exists on MK-2010 alone, researchers are studying whether its combination with sac-TMT might more effectively treat solid tumors.678910

Who Is on the Research Team?

MD

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 that can't be treated with surgery or radiation, or have come back after previous treatment. Participants need to be in good physical condition, have well-controlled HIV/HBV/HCV if present, and have healthy major organs.

Inclusion Criteria

I have had hepatitis C but my viral load is now undetectable.
My organs are working well enough for treatment.
I am fully active or restricted in physically strenuous activity only.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-In

Participants will receive MK-2010 in combination with sac-TMT to determine the safe dose

4 weeks

Signal-Finding

Participants will receive MK-2010 in combination with sac-TMT at the dose determined in Part 1

Up to approximately 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 60 months

What Are the Treatments Tested in This Trial?

Interventions

  • MK-2010
  • Sacituzumab tirumotecan

Trial Overview

The study tests a new immune therapy drug (MK-2010) combined with sacituzumab tirumotecan (Sac-TMT), which targets cancer cells directly. Supportive medicines are also used to help manage side effects. The main goal is to see how safe this combination is and if it helps shrink the cancer.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part 2: Signal-Finding CohortsExperimental Treatment8 Interventions
Group II: Part 1: Safety Lead-In CohortExperimental Treatment8 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Citations

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK ...

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, People With Breast Cancer ・ performance status of 0 or 1 performed within 28 days before cycle1 day 1 (c ...

Kelun-Biotech to Present Results from Multiple Clinical ...

Efficacy and Safety of sacituzumab tirumotecan (Sac-TMT) Monotherapy in Advanced/Metastatic Cervical Cancer: Results from a Phase 1/2 Study

Clinical Trial

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With ...

CTU: A Phase 3, Randomized, Open-label Study ...

Study to Evaluate the Efficacy and Safety of sac-TMT (Sacituzumab Tirumotecan, MK-2870) egative Breast Cancer or Hormone. Breast Cancer or Hormone

A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) ...

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this ...

A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) ...

The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer ...

Results of a phase 1/2 study of sacituzumab tirumotecan in ...

Sac-TMT demonstrated manageable safety profile in patients with unresectable locally advanced/metastatic solid tumors and promising antitumor ...

Kelun-Biotech Announces Results from the SKB264-II-06/ ...

The data showed that median progression-free survival (PFS) in the overall population was 20.9 months; median overall survival (OS) was not ...

A Clinical Study of Sacituzumab Tirumotecan in Combination ...

The goals of this study are to learn: * About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together,

Sacituzumab Tirumotecan Plus Pembrolizumab Is Set to ...

Prior data from the study revealed that sac-TMT significantly improved PFS compared with chemotherapy, with a 69% lower risk of disease ...