Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors (TusaRav-QT)

  • STATUS
    Recruiting
  • End date
    Dec 3, 2024
  • participants needed
    50
  • sponsor
    Sanofi
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Updated on 24 April 2023
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primary cancer
adenocarcinoma

Summary

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.

Description

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.

Details
Condition Neoplasm
Treatment tusamitamab ravtansine
Clinical Study IdentifierNCT05429762
SponsorSanofi
Last Modified on24 April 2023

Eligibility

 Yes No Not Sure

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
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