This study is currently not recruiting participants.

Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors

Study on Investigational Medication's Effect on Heart Rhythm (QTc Interval) in Metastatic Solid Tumors

Not Recruiting
18 years or above
All
Phase 1
56 participants needed

Study Overview

This is a Phase1, single-arm study for treatment. This is a prospective multicenter, multinational, open-label study to assess the effect of tusamitamab ravtansine on the QT interval in participants with metastatic colorectal cancer (CRC), nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GEJ) adenocarcinoma for which in the judgement of the Investigator, no standard alternative therapy is available.

Study Details

This is a single arm study in which participants will receive treatment with tusamitamab ravtansine until disease progression, unacceptable toxicity, the start of a new anti-cancer therapy, or the participant's or Investigator's decision to stop the treatment, whichever comes first.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Neoplasm
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of colorectal cancer (CRC) adenocarcinoma, nonsquamous non small cell lung cancer (NSQ NSCLC), or gastric/ gastroesophageal junction (GC/GEJ) adenocarcinoma, metastatic disease at study entry.
  • Participants with documented disease progression, for which, in the judgment of the Investigator, no alternative medical therapy is available.
  • Expression of carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) will be assessed centrally using the most recent archival tumor tissue (or, if not available, a fresh biopsy sample) and at least 5 fresh-cut slides of formalin-fixed paraffin embedded (FFPE) tumor tissue sectioned. If less material is available, the participant could still be considered eligible after discussion with the Sponsor.
    • Participants with CRC tumors may be assumed to have adequate CEACAM5 expression without testing results (it will be assessed retrospectively),
    • Participants with NSQ NSCLC must have tumors expressing CEACAM5 or high circulating CEA if tumor tissue is not available.
    • Participants with GC/GEJ must have tumors expressing CEACAM5
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as

    determined by the Investigator.

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to1.
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) and is a WOCBP and agrees to use a contraceptive method that is highly effective and for at least 7 months after the last dose of treatment. administration.
  • Male participant who agrees to use effective contraception methods during and for at least 4 months after the last dose of treatment administration.
  • Capable of giving signed informed consent.

Exclusion Criteria:

  • Untreated brain metastases that may be considered active or leptomeningeal metastasis. A participant with asymptomatic brain metastasis/metastases is eligible.
  • Significant concomitant illness
  • History within the last 2 years of an invasive malignancy other than that treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
  • Any major surgery within 3 weeks prior to of first study intervention administration.
  • Known uncontrolled infection with human immunodeficiency virus (HIV). Participants with a well-controlled HIV infection/disease must be on antiretroviral therapy (ART) to be eligible.
  • Active infection with hepatitis A, B, or C.
  • Nonresolution of any prior treatment-related toxicity .
  • Unresolved corneal disorder or any previous corneal disorder.
  • Use of contact lenses is not permitted.
  • Prior history of Torsades de Pointes, or congenital long QT syndrome.
  • Patient receives (and cannot discontinue) or is scheduled to receive a QT-prolonging drug unless if deemed necessary for the participant as per the investigators' judgment and started at least 4 weeks prior IMP administration at the same dose and the same frequency.
  • QTcF interval >480 msec on screening ECG.
  • Poor bone marrow, liver, kidney functions, or electrolytes values
  • Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

This study investigates the effect of an investigational medication on the QTc interval in people with metastatic colorectal cancer, nonsquamous non-small cell lung cancer, or gastric/gastroesophageal junction adenocarcinoma. The purpose of this study is to understand how the investigational medication affects the heart's electrical activity in these conditions.

The study focuses on evaluating the safety and impact of the investigational medication on the QTc interval. Researchers will look at how the medication interacts with the heart's rhythm and overall safety in participants.

  • Who can participate: Adults with metastatic colorectal cancer, nonsquamous non-small cell lung cancer, or gastric/gastroesophageal junction adenocarcinoma may be eligible. Participants must have progressed in their disease and have no alternative treatments available. They should have a good performance status and meet other health criteria.
  • Study details: Participants will receive the investigational medication until their disease progresses, they experience unacceptable side effects, or they or their doctor decide to stop. The study includes monitoring the heart's electrical activity. An inactive substance that looks like the investigational medicine but does not contain any medicine is known as a placebo.
Updated on 23 May 2026. Study ID: NCT05429762