Evaluation of SAR408701 in Patients With Advanced Solid Tumors

February 6, 2025 updated by: Sanofi

A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumor Activity of SAR408701 in Patients With Advanced Solid Tumors

Primary Objectives:

  • To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W).
  • To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle).
  • To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without a loading dose at Cycle 1.

Secondary Objectives:

  • To characterize the overall safety profile of SAR408701.
  • To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential circulating derivatives.
  • To identify the recommended phase 2 dose (RP2D) of SAR408701.
  • To assess the potential immunogenicity of SAR408701.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study duration for an individual patient will start from the signature of the informed consent, 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 visit around 30 days following the last administration of study drug, and at least one follow-up visit after the end-of-treatment visit. Additional follow-up visits may be required until resolution or stabilization of adverse events (at least 30 days). Treatment may continue until precluded by toxicity, progression, or upon patient's request. If the patient stops study treatment for reason other than disease progression, follow-up visit will be performed every 3 months until disease progression or initiation of another anti-tumor treatment or death, whichever comes first.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
254

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Investigational Site Number : 124001
  • France
      • Bordeaux Cedex, France, 33076
        • Investigational Site Number : 250003
      • Dijon, France, 21079
        • Investigational Site Number : 250006
      • Marseille, France, 13385
        • Investigational Site Number : 250004
      • Rennes, France, 35000
        • Investigational Site Number : 250007
      • Saint Mande, France, 94163
        • Investigational Site Number : 250005
      • TOULOUSE Cedex 9, France, 31059
        • Investigational Site Number : 250002
      • Villejuif, France, 94800
        • Investigational Site Number : 250001
  • Korea, Republic of
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, Korea, Republic of, 03080
        • Investigational Site Number : 410002
      • Seoul, Seoul-teukbyeolsi, Korea, Republic of, 03722
        • Investigational Site Number : 410005
      • Seoul, Seoul-teukbyeolsi, Korea, Republic of, 06351
        • Investigational Site Number : 410003
      • Seoul, Seoul-teukbyeolsi, Korea, Republic of, 07061
        • Investigational Site Number : 410004
      • Seoul, Seoul-teukbyeolsi, Korea, Republic of, 138-736
        • Investigational Site Number : 410001
  • Spain
      • Madrid, Spain, 28041
        • Investigational Site Number : 724006
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Investigational Site Number : 724001
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Investigational Site Number : 724002
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28050
        • Investigational Site Number : 724003
      • Madrid / Madrid, Madrid, Comunidad De, Spain, 28040
        • Investigational Site Number : 724004
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8017
        • Yale University School of Medicine Site Number : 840002
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute- Site Number : 840005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Locally advanced or metastatic solid malignant tumor disease for which no standard alternative therapy is available.
  • Availability of archived tumor tissue for carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5 or CEA) testing.
  • For participants in the Dose Escalation Cohorts (Main Escalation and Loading Dose Cohorts at every 2 week cycle and Dose Escalation every 3 week cycle): patients with tumors expressing or likely to be expressing CEACAM5 which includes colorectal cancer (CRC), non-squamous non-small cell lung cancer (NSCLC), gastric adenocarcinoma, squamous cell carcinoma of the cervix, pancreas adenocarcinoma, bladder transitional cell carcinoma, cholangiocarcinoma, epithelial ovarian cancer and endometrial adenocarcinoma are favored, or if carcinoembryonic antigen (CEA) plasma levels >5 ng/mL.
  • For participants to the Expansion Phase cohorts: patients with CRC or with CEACAM5 positive non-squamous NSCLC, small cell lung cancer (SCLC) or gastric carcinoma (including esophago-gastric junction adenocarcinoma of the Siewert types II and III).
  • At least one measurable lesion by RECIST v1.1 in the Expansion Phase only.
  • At least one lesion amenable to biopsy (Expansion cohort - CRC and gastric cancer only). Patient must consent to a baseline biopsy for retrospective confirmation of tumor CEACAM5 expression, except if NSCLC or SCLC without lesion amenable to biopsy.
  • Signed informed consent.

Exclusion criteria:

  • Aged less than 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status more than 1.
  • New or progressing brain involvement.
  • Concurrent treatment with any other anticancer therapy or inadequate wash-out period for prior anticancer therapies before first administration of SAR408701, or non-resolution of toxicities induced by these anticancer therapies.
  • Female or male patients with reproductive potential who do not agree to use an accepted effective method of contraception during the study treatment period and for at least 3 months following completion of study treatment.
  • Pregnancy or breast-feeding.
  • Participation to any clinical research study evaluating another investigational drug or therapy within 3 weeks of initiation of study regimen.
  • Prior therapy targeting CEACAM5.
  • Prior maytansinoid treatments (DM1 or DM4 antibody drug conjugates).
  • Poor bone marrow reserve resulting in low blood cell counts.
  • Poor kidney and liver functions.
  • Any of the following within 6 months prior to study enrolment: infectious or inflammatory bowel disease, diverticulitis, gastrointestinal perforation, intestinal obstruction, and gastrointestinal hemorrhage. Patients with malabsorption syndrome are excluded.
  • Previous history and or unresolved corneal disorders. The use of contact lenses is not permitted.
  • Unresolved signs and symptoms of neuropathy; Grade 1 is acceptable if prior neurotoxic drugs such as cisplatin or taxanes.
  • Abnormal cardiac function defined by a left ventricular ejection fraction (LVEF) of <50%.
  • Cardiac conduction defects, or any other clinically significant arrhythmias.
  • Known intolerance to infused protein products.
  • Medical conditions requiring concomitant administration of medications with narrow therapeutic window, metabolized by cytochrome P450 (CYPs) enzymes 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 1st administration of SAR408701.
  • Contraindications to the use of ophthalmic vasoconstrictor and/or corticosteroid as per package insert of each drug, including the following: increase intraocular pressure, prior or current glaucoma, narrow-angle glaucoma, ongoing eye infection, uncontrolled hypertension, known/suspected allergy to constituents of the preparation (such as sodium bisulfite).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SAR408701 Main Dose Escalation Cohort
Dose escalation administered intravenously, once every two weeks
Drug: SAR408701
Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous
Experimental: SAR408701 Expansion Cohort colorectal cancer (CRC)
Administered intravenously at the maximum tolerated dose (MTD), once every 2 weeks, to patients with colorectal cancer
Drug: SAR408701
Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous
Experimental: SAR408701 Expansion Cohort non-squamous NSCLC
Administered intravenously at the MTD, once every 2 weeks, to patients with carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expressing non-squamous non-small cell lung cancer (NSCLC) of at least 50% of tumor cells at or above 2+ intensity
Drug: SAR408701
Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous
Experimental: SAR408701 Expansion Cohort gastric adenocarcinoma
Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing gastric adenocarcinoma
Drug: SAR408701
Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous
Experimental: SAR408701 Loading Dose Escalation cohorts (Escalation bis)
Loading dose escalation administered intravenously at first cycle, followed by MTD, once every 2 weeks
Drug: SAR408701
Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous
Experimental: SAR408701 Expansion Cohort non-squamous NSCLC (Lung bis)
Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing non-squamous NSCLC of at least 1% but below 50% of tumor cells at or above 2+ intensity
Drug: SAR408701
Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous
Experimental: SAR408701 Expansion Cohort colorectal cancer (CRC-L)
Loading dose of determined MTD-L administered intravenously at first cycle, followed by MTD, once every 2 weeks
Drug: SAR408701
Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous
Experimental: SAR408701 Expansion Cohort small cell lung cancer (SCLC)
Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing SCLC
Drug: SAR408701
Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous
Experimental: SAR408701 Dose Escalation every 3 weeks cohort
Dose escalation administered intravenously, once every three weeks
Drug: SAR408701
Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of dose limiting adverse events (every 2 week cycle)
Time Frame: 4 weeks
4 weeks
Assessment of overall response rate using standard imaging and RECIST 1.1 criteria
Time Frame: Up to 40 months
Up to 40 months
Number of dose limiting adverse events (every 3 week cycle)
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of treatment emergent adverse events
Time Frame: Up to 4 years
Up to 4 years
Maximum concentration (Cmax)
Time Frame: 2 months
2 months
Time to reach maximum concentration (tmax)
Time Frame: 2 months
2 months
Trough plasma concentrations (Ctrough)
Time Frame: Intensive testing within first 2 months, then every 2 weeks
Intensive testing within first 2 months, then every 2 weeks
Area under the plasma concentration versus time curve between 0 and 14 days (AUC0-14day) for Q2W or between 0 and 21 days (AUC-21 day) for Q3W
Time Frame: 2 months
2 months
Mean systemic clearance (CL)
Time Frame: 2 months
2 months
Clearance at steady state (CLss)
Time Frame: 2 months
2 months
Accumulation ratio (Rac) on AUC0-14day and Cmax
Time Frame: 2 months
2 months
Detection of the development of anti-SAR408701 antibody
Time Frame: Up to 40 months
Up to 40 months
Duration of response
Time Frame: Up to 40 months - assessment every 6-8 weeks
Up to 40 months - assessment every 6-8 weeks
Time to Progression
Time Frame: Up to 40 months - assessment every 6-8 weeks
Up to 40 months - assessment every 6-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 23, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TED13751
  • 2014-001130-29 (EudraCT Number)
  • U1111-1153-3461 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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