Study on TAK-186 (MVC-101) for Adults with Advanced or Metastatic Cancer

Sponsor: Takeda

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04844073

Provider View

This clinical trial is testing a new drug, TAK-186 (also known as MVC-101), to see if it is safe and well-tolerated in adults with advanced or metastatic cancer that cannot be surgically removed. Participants may receive treatment for up to 13 months and will have follow-up visits for up to 48 weeks after the last treatment.

Patient Parameters

Program Overview

The main goal of this study is to evaluate the safety and side effects of TAK-186 (MVC-101) in adults with advanced or metastatic cancer that cannot be removed by surgery. The study will also assess how well the drug works against tumors. Participants may receive treatment for up to 13 months and will be monitored at 30 days, 90 days, and every 12 weeks for up to 48 weeks after their last treatment.

Description

This study is in Phase 1/2 and is open-label, meaning both the researchers and participants know what treatment is being given. The study will first determine the safety and any dose-limiting side effects of TAK-186. The dose will be increased in participants with advanced solid tumors to find the best dose. In the next phase, more participants with tumors that express a protein called EGFR, including certain types of lung, colorectal, and head and neck cancers, will be enrolled to further evaluate the drug's safety and initial effectiveness against tumors.

Eligibility Criteria

Inclusion Criteria

  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must be able to provide informed consent and agree to follow study procedures, including providing research samples.
  • Must have a life expectancy of at least 12 weeks.
  • Must have measurable disease as defined by specific criteria and confirmed by scans.
  • Must have a type of cancer that is known to express EGFR, such as certain lung, colorectal, or head and neck cancers.
  • Must provide a tumor sample for research purposes.
  • Must have acceptable blood and organ function as determined by specific lab tests.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study and for 90 days after the last dose.
  • Men must use barrier contraception during the study and for 120 days after the last dose and ensure their partners use contraception as well.
  • Must have resolved any side effects from previous immune checkpoint inhibitor therapy to a mild level or baseline.
  • Must have treated and stable brain metastases, if present, with no ongoing treatment required.

Exclusion Criteria

  • History of autoimmune diseases, except for certain conditions like vitiligo, well-controlled diabetes, or hypothyroidism managed with medication.
  • Recent major surgery or injury that has not healed.
  • Recent radiation therapy or treatment with high doses of steroids or other immune-suppressing drugs.
  • Recent treatment with certain cancer therapies.
  • Significant heart or blood vessel diseases, such as recent heart attack or uncontrolled high blood pressure.
  • Significant gastrointestinal issues, such as recent perforation or bleeding.
  • Active infections requiring treatment or recent vaccination with live vaccines.
  • Known HIV or hepatitis B or C infection, unless well-controlled.
  • Another invasive cancer not in remission for at least 3 years, with some exceptions.
  • Any serious medical or psychiatric condition that would prevent understanding the study or receiving treatment.
  • Known allergy to TAK-186 or its components.
  • Individuals who are detained or unable to consent.
  • Women who are breastfeeding.

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