Status:
TERMINATED
Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors
Lead Sponsor:
Sanofi
Conditions:
Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 w...
Detailed 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 par...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05429762
Start Date
October 3 2022
End Date
April 10 2024
Last Update
April 6 2025
Active Locations (7)
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1
Mary Crowley Cancer Research Center Site Number : 8400002
Dallas, Texas, United States, 75230
2
Investigational Site Number : 0560001
Edegem, Belgium, 2650
3
Investigational Site Number : 2500001
Dijon, France, 21079
4
Investigational Site Number : 2500002
Marseille, France, 13385