Neoplasm MalignantPhase 1NCT03324113

Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors

A Phase 1 study testing SAR408701, dexamethasone and naphazoline in people with Neoplasm Malignant, run by Sanofi at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary Objective: To evaluate tolerability and safety of SAR408701 when administered as a single agent according to the investigational medicinal product (IMP) related dose limiting toxicities (DLTs) to determine the recommended dose (RD) of SAR408701 in Japanese patients with advanced malignant solid tumors. Read more about this study

Who is it for?: Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for: Neoplasm Malignant
What is being tested?: SAR408701, dexamethasone and naphazoline
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 3 sitesJapan
Study dates: 17 Oct 2017to 26 Dec 2022
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 20 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Locally advanced or metastatic solid malignant tumor disease for which, in the judgement of the investigator, no standard alternative therapy is available.
At least 6 x 5 μm slides from formalin-fixed paraffin-embedded (FFPE) archival tissue should be available for retrospective central evaluation of CEACAM5 expression.
Patient understands and has signed the Written Informed Consent form and is willing and able to comply with the requirements of the trial.

Who cannot join

Patient less than 20 years old.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥2.
Life expectancy <12 weeks.
Known or symptomatic brain metastasis (other than totally resected or previously irradiated and non-progressive/relapsing) or lepto-meningeal carcinomatosis.
Female patients of childbearing potential and male patients with female partners of childbearing potential who do not agree to use accepted and effective method of contraception during the study treatment period and for 6 months following discontinuation of IMP.
Significant concomitant illnesses, including all severe medical conditions which, in the opinion of the Investigator or Sponsor, would impair the patient's participation in the study or interpretation of the results.

Show all 12Show fewer

Prior therapy targeting CEACAM5.
Prior maytansinoid treatments (maytansinoid derivative 1 [DM1] or maytansinoid derivative 4 [DM4] antibody drug conjugates).
Previous history and or unresolved corneal disorders.
Medical conditions requiring concomitant administration of medications with narrow therapeutic window, metabolized by cytochrome P450 (CYP) and for which a dose reduction cannot be considered.
Medical conditions requiring concomitant administration of strong CYP3A inhibitor, unless it can be discontinued at least 2 weeks before first administration of SAR408701.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Investigational Site Number : 3920003
Kashiwa-shi, Chiba, 277-8577
Investigational Site Number : 3920002
Nagoya, Aichi-ken, 464-8681
Investigational Site Number : 3920001
Sunto-gun, Shizuoka, 411-8777

Other trials in Japan

About this study

Official title: A Phase I Study to Evaluate Safety and Pharmacokinetics of SAR408701 Administered Intravenously as Monotherapy in Japanese Patients With Advanced Malignant Solid Tumors

Primary Objective:

To evaluate tolerability and safety of SAR408701 when administered as a single agent according to the investigational medicinal product (IMP) related dose limiting toxicities (DLTs) to determine the recommended dose (RD) of SAR408701 in Japanese patients with advanced malignant solid tumors.

Secondary Objectives:

To characterize the overall safety profile of SAR408701 monotherapy.
To characterize the pharmacokinetic (PK) profile of SAR408701 and its metabolites.
To evaluate the pharmacodynamic (PDy) effect of SAR408701 on levels of circulating carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) for main dose escalation part.
To assess preliminary efficacy according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and other indicators of antitumor activity.
To assess the potential immunogenicity of SAR408701.

Read the detailed description

The study duration per participant will include a period to assess eligibility (screening period) of up to approximately 4 weeks (28 days), a treatment period and an End-of-Treatment (EOT) visit around 30 days after the last administration of IMP, and at least one follow-up (FU) visit after the EOT visit.

Conditions: Neoplasm Malignant
Being tested: SAR408701, dexamethasone, naphazoline, diphenhydramine
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SAR408701Drug
Also called Tusamitamab ravtansine
Pharmaceutical form: solution for infusion
Route of administration: intravenous
dexamethasoneDrug
Also called Santeson ophthalmic solution
Pharmaceutical form: solution for eye drop
Route of administration: eye drop
naphazolineDrug
Also called Clearine
Pharmaceutical form: solution for eye drop
Route of administration: eye drop
diphenhydramineDrug
Also called Restamin Kowa
Pharmaceutical form: tablet
Route of administration: oral

Study groups in NCT03324113
Study group	Role	What they receive
SAR408701 Monotherapy	Experimental	SAR408701 Dose escalation administered as a single agent intravenously, on Day 1 and once every two weeks, to patients with malignant solid tumors Receives: Drug: SAR408701; Drug: dexamethasone; Drug: naphazoline; Drug: diphenhydramine

What is being measured

The primary outcome is the main question the study is designed to answer.

IMP-related dose limiting toxicities (DLT)
IMP-related DLTs are defined as adverse events (AE) related to the IMPs in absence of clear evidence to the contrary, after validation by the Study Committee, and if not related to a disease progression, graded using National Cancer Institute common Toxicity Criteria (NCI-CTC) scale v4.03
Measured: 4 weeks, Dose escalation q3w part: 3 weeks

Secondary outcomes (10)

Treatment emergent adverse events
Overall safety profile characterized in terms of the type, frequency, severity, seriousness, and relationship to study therapy of any AEs based on standard and systematic assessment including physical findings, laboratory tests or other investigations
Measured: Up to an average of 9 months
Maximum observed concentration (Cmax) of SAR408701
Cmax for SAR408701 will be assessed after single and repeat doses, as relevant
Measured: Main dose-escalation part: Cycle 1 and Cycle 4 (each cycle is 14 days); Dose-escalation bis part with loading dose: Cycle 1 (Cycle 1 is 14 days), Dose-escalation q3w part: Cycle 1 and Cycle2 day 1 (Cycle 1 is 21 days)
Cmax of DM4 and Me-DM4
Cmax for DM4 and Me-DM4 will be assessed after single and repeat doses, as relevant
Measured: Main dose-escalation part: Cycle 1 and Cycle 4 (each cycle is 14 days); Dose-escalation bis part with loading dose: Cycle 1 (Cycle 1 is 14 days), Dose-escalation q3w part: Cycle 1 and Cycle2 day 1 (Cycle 1 is 21 days)
Time to reach maximum concentration (Tmax) of SAR408701
Tmax for SAR408701 will be assessed after single and repeat doses, as relevant
Measured: Main dose-escalation part: Cycle 1 and Cycle 4 (each cycle is 14 days); Dose-escalation bis part with loading dose: Cycle 1 (Cycle 1 is 14 days), Dose-escalation q3w part: Cycle 1 and Cycle2 day 1 (Cycle 1 is 21 days)
Tmax of DM4 and Me-DM4
Tmax for DM4 and Me-DM4 will be assessed after single and repeat doses, as relevant
Measured: Main dose-escalation part: Cycle 1 and Cycle 4 (each cycle is 14 days); Dose-escalation bis part with loading dose: Cycle 1 (Cycle 1 is 14 days), Dose-escalation q3w part: Cycle 1 and Cycle2 day 1 (Cycle 1 is 21 days)
Area under the concentration-time curve (AUC) of SAR408701
AUC of SAR408701 from time zero extrapolated to infinity
Measured: Main dose-escalation part: Cycle 1 and Cycle 4 (each cycle is 14 days); Dose-escalation bis part with loading dose: Cycle 1 (Cycle 1 is 14 days), Dose-escalation q3w part: Cycle 1 and Cycle2 day 1 (Cycle 1 is 21 days)
AUC of DM4 and Me-DM4
AUC of DM4 and Me-DM4 from time zero extrapolated to infinity
Measured: Main dose-escalation part: Cycle 1 and Cycle 4 (each cycle is 14 days); Dose-escalation bis part with loading dose: Cycle 1 (Cycle 1 is 14 days), Dose-escalation q3w part: Cycle 1 and Cycle2 day 1 (Cycle 1 is 21 days)
Assessment of PDy effect
Assessment of plasma CEACAM5 levels in main dose-escalation part
Measured: Up to an average of 10 months
Assessment of anti-tumor activity
Assessment of tumor response using standard imaging, as defined by RECIST 1.1 criteria
Measured: Up to an average of 10 months
Detection of anti-SAR408701 antibody
Immunogenicity evaluation for anti-SAR408701 antibodies
Measured: Up to an average of 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 201726 Dec 2022

First posted27 Oct 2017
Study start17 Oct 2017
Primary completion18 Nov 2022
Study completion26 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neoplasm MalignantStudies 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: Sequential
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03324113
Sponsor's protocol ID: TCD15054
Other IDs: U1111-1191-5464, TCD15054
Status last verified: Jul 2025
First submitted: 6 Oct 2017
Last updated: 5 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
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

Publications

Muro K, Yamazaki K, Kadowaki S, Mishima S, Kawakami T, Tanaka T, Tada K, Fagniez N, Ohshima S, Yoshino T. Phase 1 study evaluating safety and pharmacokinetics of tusamitamab ravtansine monotherapy in Japanese patients with advanced malignant solid tumors. Int J Clin Oncol. 2025 Aug;30(8):1522-1536. doi: 10.1007/s10147-025-02784-4. Epub 2025 May 25.
PubMed 40413667

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study to Evaluate Safety and Pharmacokinetics of SAR408701 Administered Intravenously as Monotherapy in Japanese Patients With Advanced Malignant Solid Tumors
ClinicalTrials.gov ID: NCT03324113
Acronym / sponsor ID: TCD15054
Conditions: Neoplasm Malignant
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: 17 Oct 2017 (actual)
Primary completion: 18 Nov 2022 (actual)
Study completion: 26 Dec 2022 (actual)
First posted: 27 Oct 2017 (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.

Primary Objective:

To evaluate tolerability and safety of SAR408701 when administered as a single agent according to the investigational medicinal product (IMP) related dose limiting toxicities (DLTs) to determine the recommended dose (RD) of SAR408701 in Japanese patients with advanced malignant solid tumors.

Secondary Objectives:

To characterize the overall safety profile of SAR408701 monotherapy.
To characterize the pharmacokinetic (PK) profile of SAR408701 and its metabolites.
To evaluate the pharmacodynamic (PDy) effect of SAR408701 on levels of circulating carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) for main dose escalation part.
To assess preliminary efficacy according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and other indicators of antitumor activity.
To assess the potential immunogenicity of SAR408701.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SAR408701 Monotherapy	Experimental	Drug: SAR408701, Drug: dexamethasone, Drug: naphazoline, Drug: diphenhydramineSAR408701 Dose escalation administered as a single agent intravenously, on Day 1 and once every two weeks, to patients with malignant solid tumors

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Locally advanced or metastatic solid malignant tumor disease for which, in the judgement of the investigator, no standard alternative therapy is available.
At least 6 x 5 μm slides from formalin-fixed paraffin-embedded (FFPE) archival tissue should be available for retrospective central evaluation of CEACAM5 expression.
Patient understands and has signed the Written Informed Consent form and is willing and able to comply with the requirements of the trial.

Key exclusion criteria (12 listed)

Patient less than 20 years old.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥2.
Life expectancy <12 weeks.
Known or symptomatic brain metastasis (other than totally resected or previously irradiated and non-progressive/relapsing) or lepto-meningeal carcinomatosis.
Female patients of childbearing potential and male patients with female partners of childbearing potential who do not agree to use accepted and effective method of contraception during the study treatment period and for 6 months following discontinuation of IMP.

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
SAR408701Also: Tusamitamab ravtansinePharmaceutical form: solution for infusion Route of administration: intravenous	Drug	SAR408701 Monotherapy
dexamethasoneAlso: Santeson ophthalmic solutionPharmaceutical form: solution for eye drop Route of administration: eye drop	Drug	SAR408701 Monotherapy
naphazolineAlso: ClearinePharmaceutical form: solution for eye drop Route of administration: eye drop	Drug	SAR408701 Monotherapy
diphenhydramineAlso: Restamin KowaPharmaceutical form: tablet Route of administration: oral	Drug	SAR408701 Monotherapy

Primary outcome

IMP-related dose limiting toxicities (DLT)
Time frame: 4 weeks, Dose escalation q3w part: 3 weeks
IMP-related DLTs are defined as adverse events (AE) related to the IMPs in absence of clear evidence to the contrary, after validation by the Study Committee, and if not related to a disease progression, graded using National Cancer Institute common Toxicity Criteria (NCI-CTC) scale v4.03

10 secondary outcomes

Treatment emergent adverse events
Time frame: Up to an average of 9 months
Maximum observed concentration (Cmax) of SAR408701
Time frame: Main dose-escalation part: Cycle 1 and Cycle 4 (each cycle is 14 days); Dose-escalation bis part with loading dose: Cycle 1 (Cycle 1 is 14 days), Dose-escalation q3w part: Cycle 1 and Cycle2 day 1 (Cycle 1 is 21 days)
Cmax of DM4 and Me-DM4
Time frame: Main dose-escalation part: Cycle 1 and Cycle 4 (each cycle is 14 days); Dose-escalation bis part with loading dose: Cycle 1 (Cycle 1 is 14 days), Dose-escalation q3w part: Cycle 1 and Cycle2 day 1 (Cycle 1 is 21 days)
Time to reach maximum concentration (Tmax) of SAR408701
Time frame: Main dose-escalation part: Cycle 1 and Cycle 4 (each cycle is 14 days); Dose-escalation bis part with loading dose: Cycle 1 (Cycle 1 is 14 days), Dose-escalation q3w part: Cycle 1 and Cycle2 day 1 (Cycle 1 is 21 days)
Tmax of DM4 and Me-DM4
Time frame: Main dose-escalation part: Cycle 1 and Cycle 4 (each cycle is 14 days); Dose-escalation bis part with loading dose: Cycle 1 (Cycle 1 is 14 days), Dose-escalation q3w part: Cycle 1 and Cycle2 day 1 (Cycle 1 is 21 days)
Area under the concentration-time curve (AUC) of SAR408701
Time frame: Main dose-escalation part: Cycle 1 and Cycle 4 (each cycle is 14 days); Dose-escalation bis part with loading dose: Cycle 1 (Cycle 1 is 14 days), Dose-escalation q3w part: Cycle 1 and Cycle2 day 1 (Cycle 1 is 21 days)
AUC of DM4 and Me-DM4
Time frame: Main dose-escalation part: Cycle 1 and Cycle 4 (each cycle is 14 days); Dose-escalation bis part with loading dose: Cycle 1 (Cycle 1 is 14 days), Dose-escalation q3w part: Cycle 1 and Cycle2 day 1 (Cycle 1 is 21 days)
Assessment of PDy effect
Time frame: Up to an average of 10 months
Assessment of anti-tumor activity
Time frame: Up to an average of 10 months
Detection of anti-SAR408701 antibody
Time frame: Up to an average of 10 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
Results publication: PubMed 40413667Muro K, Yamazaki K, Kadowaki S, Mishima S, Kawakami T, Tanaka T, Tada K, Fagniez N, Ohshima S, Yoshino T. Phase 1 study evaluating safety and pharmacokinetics of tusamitamab ravtansine monotherapy in Japanese patients with advanced malignant solid tumors. Int J Clin Oncol. 2025 Aug;30(8):1522-1536. doi: 10.1007/s10147-025-02784-4. Epub 2025 May 25.
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

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAR408701, dexamethasone and naphazoline in people with Neoplasm Malignant, run by Sanofi at 3 sites in Japan.

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 3 inclusion and 12 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: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

IMP-related dose limiting toxicities (DLT) (time frame: 4 weeks, Dose escalation q3w part: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03324113, which also lists 1 linked publication.

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 5 Aug 2025.