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Study on MK-6070 and Ifinatamab Deruxtecan for Patients with Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as small cell lung cancer. This is a condition where cancer cells form in the tissues of the lung and can spread quickly to other parts of the body. The study is investigating two treatments: MK-6070 and Ifinatamab Deruxtecan, also known by its code name I-DXd. Both treatments are given as a solution through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and effectiveness of these treatments in people whose cancer has returned or has not responded to previous treatments. The study will be conducted in two parts. In the first part, participants will receive either a combination of MK-6070 and I-DXd or I-DXd alone, to see how well these treatments are tolerated and how effective they are. In the second part, the focus will be on the safety and tolerability of MK-6070 alone in participants in Japan.

Participants in the study will receive the treatments at different times and will be monitored for any side effects or changes in their condition. The study aims to gather information on how the body responds to these treatments, including how long the treatments stay in the body and how they are processed. This information will help researchers understand the potential benefits and risks of these new treatment options for small cell lung cancer.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of extensive-stage small cell lung cancer and ensuring previous treatment with platinum-based chemotherapy.

A tissue sample, either archival or fresh biopsy, is required for further analysis.

2 treatment phase 1

The first part of the treatment involves the administration of MK-6070 in combination with ifinatamab deruxtecan (I-DXd) or I-DXd alone. The method of administration is through an intravenous infusion.

The frequency of I-DXd monotherapy is every two weeks. The combination schedule may vary based on individual assessments.

3 monitoring and evaluation

Throughout the treatment, regular monitoring is conducted to evaluate safety and tolerability. This includes tracking any adverse events or dose-limiting toxicities.

The objective response rate (ORR) is assessed to determine the effectiveness of the treatment.

4 treatment phase 2

In the second part of the study, participants in Japan receive MK-6070 as a monotherapy. The focus remains on evaluating safety and tolerability.

The administration continues through intravenous infusion, with specific schedules determined by the study protocol.

5 ongoing assessments

Participants undergo continuous assessments to measure various pharmacokinetic parameters such as maximum concentration and time to maximum concentration of the drugs.

The duration of response and progression-free survival are also evaluated to understand the long-term effects of the treatment.

6 completion and follow-up

Upon completion of the treatment phases, a follow-up period is conducted to monitor any long-term effects or adverse events.

The study is estimated to conclude by December 16, 2027, with ongoing evaluations to ensure participant safety and gather comprehensive data.

Who Can Join the Study?

  • The patient must have small cell lung cancer that is in an extensive stage. This means the cancer has spread widely in the body. The patient should have already received at least one type of treatment that included platinum-based chemotherapy.
  • The patient must be able to provide a sample of their cancer tissue. This can be an archival tissue sample, which is a sample taken in the past, or a fresh biopsy tissue sample, which is a new sample taken from the body.
  • If the patient is infected with the human immunodeficiency virus (HIV), their HIV must be well controlled with antiretroviral therapy (ART). This means they are taking medication to manage their HIV effectively.
  • The study is open to both male and female participants.
  • The study is not specifically for vulnerable populations, meaning it does not focus on groups that might need special protection or care.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides small cell lung cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
  • Patients who have not met the specific health requirements set by the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have certain medical conditions that could interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have allergies to the study medications cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
Ivleguel Cygfiv Dkvukqueikatxjomz L'hospitalet De Llobregat Spain
Hsimdknm Vxhp dknlvjee Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
07.02.2025

Trial locations

Investigated drugs:

MK-6070 is a medication being studied for its safety and effectiveness in treating patients with relapsed or refractory extensive-stage small cell lung cancer. In this trial, it is being tested both alone and in combination with another medication to see how well it works and how well patients can tolerate it.

Ifinatamab Deruxtecan (I-DXd) is another medication involved in this study. It is being evaluated for its safety and effectiveness when used alone or in combination with MK-6070. The study aims to determine the best way to use this medication to help patients with extensive-stage small cell lung cancer who have not responded to previous treatments.

Investigated diseases:

Small Cell Lung Cancer – This is a fast-growing type of lung cancer that primarily affects smokers. It is characterized by small cells that multiply quickly and form large tumors. These tumors can spread rapidly to other parts of the body, including the brain, liver, and bones. The disease often starts in the bronchi, which are the main airways of the lungs. As it progresses, it can cause symptoms such as coughing, chest pain, and difficulty breathing. Due to its aggressive nature, it is often diagnosed at an advanced stage.

Trial ID:
2024-517926-25-00
Protocol code:
MK-6070-002
Trial Phase:
Human Pharmacology (Phase I) – Other

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