NeoplasmPhase 1TusaRav-QTNCT05429762
Effect of Tusamitamab Ravtansine on QTc Interval in Participants With Metastatic Solid Tumors
A Phase 1 study testing Tusamitamab ravtansine in people with Neoplasm, run by Sanofi at 7 sites in 5 countries.
Trial 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/… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm
- What is being tested?
- Tusamitamab ravtansine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 3 Oct 2022to 10 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
France2 sites
Investigational Site Number : 2500001
Dijon, 21079
Investigational Site Number : 2500002
Marseille, 13385
Spain2 sites
Investigational Site Number : 7240002
Barcelona, Catalunya [Cataluña], 08023
Investigational Site Number : 7240001
Madrid, Madrid, Comunidad de, 28040
United States1 site
Mary Crowley Cancer Research Center Site Number : 8400002
Dallas, Texas, 75230
Turkey (Türkiye)1 site
Investigational Site Number : 7920001
Ankara, 06800
About this study
Official title: Open-label Study Evaluating the Effect of Tusamitamab Ravtansine on the QTc Interval in Participants With Metastatic Solid Tumors
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.
Read the 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 participant's or Investigator's decision to stop the treatment, whichever comes first.
- Conditions
- Neoplasm
- Being tested
- Tusamitamab ravtansine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tusamitamab ravtansineDrug
Also called SAR408701
Pharmaceutical form: Concentrated solution for intravenous (IV) administration; Route of administration: IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tusamitamab ravtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QT-interval corrected (QTcF) centrally assessed
Measured: Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)
Secondary outcomes (10)
Electrocardiogram (ECG) parameter: heart rate (HR)
To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as heart rate (HR).
Measured: Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)
ECG parameter: QT interval
To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as QT interval.
Measured: Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)
ECG parameter: QT interval corrected according to the Bazett's formula (QTcB)
To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as QT interval corrected according to the Bazett's formula (QTcB).
Measured: Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)
ECG parameter: QRS interval
To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as QRS interval.
Measured: Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)
ECG parameter: PR interval
To assess the effect of tusamitamab ravtansine (i.e., change from baseline) on cardiac parameters such as PR interval.
Measured: Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)
Maximum concentration observed (Cmax)
Measured: Multiple timepoint at Cycle 1 (1 Cycle = 2 weeks)
Area under the plasma concentration versus time curve from time 0 to 14 days (AUC0-14d)
Measured: Multiple timepoint at Cycle 1 (1 Cycle = 2 weeks)
Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities
Assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: From the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks
Overall response rate (ORR)
The ORR, defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as the best overall response as determined by investigator/local radiologist review per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria
Measured: Up to approximately 30 weeks
Duration of response (DOR)
The DOR, defined as the time from the first documented evidence of confirmed complete response (CR) or partial response (PR) until progressive disease (PD) as determined by investigator/local radiologist review per RECIST v1.1 criteria or death (due to any cause), whichever comes first
Measured: Up to approximately 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start3 Oct 2022
- Primary completion1 Aug 2023
- Study completion10 Apr 2024
Why it stopped: Tusamitamab ravtansine clinical development program is discontinued as CARMEN-LC03 trial did not meet dual primary endpoint of improving progression-free survival. The decision is not related to any safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429762
- Sponsor's protocol ID
- TES16382
- Other IDs
- U1111-1269-6291, 2022-001213-39
- Acronym
- TusaRav-QT
- Status last verified
- Apr 2025
- First submitted
- 8 Jun 2022
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study Evaluating the Effect of Tusamitamab Ravtansine on the QTc Interval in Participants With Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05429762
- Acronym / sponsor ID
- TusaRav-QT / TES16382
- Conditions
- Neoplasm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Tusamitamab ravtansine clinical development program is discontinued as CARMEN-LC03 trial did not meet dual primary endpoint of improving progression-free survival. The decision is not related to any safety concern.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 10 Apr 2024 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 participant's or Investigator's decision to stop the treatment, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tusamitamab ravtansine | Experimental | Drug: Tusamitamab ravtansineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tusamitamab ravtansineAlso: SAR408701Pharmaceutical form: Concentrated solution for intravenous (IV) administration; Route of administration: IV infusion | Drug | Tusamitamab ravtansine |
Primary outcome
Change from baseline in QT-interval corrected (QTcF) centrally assessed
Time frame: Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)
10 secondary outcomes
Electrocardiogram (ECG) parameter: heart rate (HR)
Time frame: Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)
ECG parameter: QT interval
Time frame: Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)
ECG parameter: QT interval corrected according to the Bazett's formula (QTcB)
Time frame: Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)
ECG parameter: QRS interval
Time frame: Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)
ECG parameter: PR interval
Time frame: Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)
Maximum concentration observed (Cmax)
Time frame: Multiple timepoint at Cycle 1 (1 Cycle = 2 weeks)
Area under the plasma concentration versus time curve from time 0 to 14 days (AUC0-14d)
Time frame: Multiple timepoint at Cycle 1 (1 Cycle = 2 weeks)
Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities
Time frame: From the date of first infusion up to approximately 30 days after the last infusion i.e., up approximately 34 weeks
Overall response rate (ORR)
Time frame: Up to approximately 30 weeks
Duration of response (DOR)
Time frame: Up to approximately 30 weeks
Results and safety
The study was stopped early (reason given: Tusamitamab ravtansine clinical development program is discontinued as CARMEN-LC03 trial did not meet dual primary endpoint of improving progression-free survival. The decision is not related to any safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- TES16382 Plain language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tusamitamab ravtansine in people with Neoplasm, run by Sanofi at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Spain, United States, Belgium, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Tusamitamab ravtansine clinical development program is discontinued as CARMEN-LC03 trial did not meet dual primary endpoint of improving progression-free survival. The decision is not related to any safety concern.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in QT-interval corrected (QTcF) centrally assessed (time frame: Baseline, Cycle 1, and Cycle 2 (1 Cycle = 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.