Open-label Study Evaluating the Effect of Tusamitamab Ravtansine on the QTc Interval in Participants With Metastatic Solid Tumors

Status: Terminated
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Mary Crowley Cancer Research Center Site Number : 8400002
Dallas
Other Locations
Belgium
Investigational Site Number : 0560001
Edegem
France
Investigational Site Number : 2500001
Dijon
Investigational Site Number : 2500002
Marseille
Spain
Investigational Site Number : 7240002
Barcelona
Investigational Site Number : 7240001
Madrid
Turkey
Investigational Site Number : 7920001
Ankara
Time Frame
Start Date: 2022-10-03
Completion Date: 2024-04-10
Participants
Target number of participants: 56
Treatments
Experimental: Tusamitamab ravtansine
Participants will receive tusamitamab ravtansine intravenous (IV) infusion 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.
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov

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