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

NCT05429762 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: TES16382U1111-1269-62912022-001213-39
• Study Type: interventional
• Target: 56
• Locations: 5 countries
• Sites: 7

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 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.

Conditions

Neoplasm

Outcome Measures

Primary Outcomes (1)

• Change from baseline in QT-interval corrected (QTcF) centrally assessed

  Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)

Secondary Outcomes (10)

• Electrocardiogram (ECG) parameter: heart rate (HR)

  Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)

• ECG parameter: QT interval

  Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)

• ECG parameter: QT interval corrected according to the Bazett's formula (QTcB)

  Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)

• ECG parameter: QRS interval

  Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)

• ECG parameter: PR interval

  Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)

Study Arms (1)

Tusamitamab ravtansine

EXPERIMENTAL

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.

Drug: Tusamitamab ravtansine

Interventions

Tusamitamab ravtansine DRUG

Pharmaceutical form: Concentrated solution for intravenous (IV) administration; Route of administration: IV infusion

Also known as: SAR408701

Tusamitamab ravtansine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (7)

Mary Crowley Cancer Research Center Site Number : 8400002

Dallas, Texas, 75230, United States

Location

Investigational Site Number : 0560001

Edegem, 2650, Belgium

Location

Investigational Site Number : 2500001

Dijon, 21079, France

Location

Investigational Site Number : 2500002

Marseille, 13385, France

Location

Investigational Site Number : 7240002

Barcelona, Catalunya [Cataluña], 08023, Spain

Location

Investigational Site Number : 7240001

Madrid, Madrid, Comunidad de, 28040, Spain

Location

Investigational Site Number : 7920001

Ankara, 06800, Turkey (Türkiye)

Location

Related Links

• TES16382 Plain language Results Summary

MeSH Terms

Conditions

Neoplasms

Interventions

tusamitamab ravtansine

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 23, 2022
• Study Start: October 3, 2022
• Primary Completion: August 1, 2023
• Study Completion: April 10, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

TU (1); BE (1); FR (2); ES (2); US (1)