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Completed

NCT Number: NCT03324113

Evaluation of SAR408701 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.

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Key information

Conditions

Neoplasm Malignant Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site Number : 3920002, Nagoya, Aichi-ken, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Locally advanced or metastatic solid malignant tumor disease for which, in the judgement of the investigator, no standard alternative therapy is available.
  • Inclusion is likely to be expressing CEACAM5.
  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

SAR408701

Drug

Pharmaceutical form: solution for infusion

Route of administration: intravenous

Other names: Tusamitamab ravtansine

Dexamethasone

Drug

Pharmaceutical form: solution for eye drop

Route of administration: eye drop

Other names: Santeson ophthalmic solution

naphazoline

Drug

Pharmaceutical form: solution for eye drop

Route of administration: eye drop

Other names: Clearine

diphenhydramine

Drug

Pharmaceutical form: tablet

Route of administration: oral

Other names: Restamin Kowa

Primary outcomes

  1. 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

Secondary outcomes

  1. Treatment emergent adverse events

    Time frame: Up to an average of 9 months

    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

  2. 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 for SAR408701 will be assessed after single and repeat doses, as relevant

  3. 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)

    Cmax for DM4 and Me-DM4 will be assessed after single and repeat doses, as relevant

  4. 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 for SAR408701 will be assessed after single and repeat doses, as relevant

  5. 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)

    Tmax for DM4 and Me-DM4 will be assessed after single and repeat doses, as relevant

  6. 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 SAR408701 from time zero extrapolated to infinity

  7. 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)

    AUC of DM4 and Me-DM4 from time zero extrapolated to infinity

  8. Assessment of PDy effect

    Time frame: Up to an average of 10 months

    Assessment of plasma CEACAM5 levels in main dose-escalation part

  9. Assessment of anti-tumor activity

    Time frame: Up to an average of 10 months

    Assessment of tumor response using standard imaging, as defined by RECIST 1.1 criteria

  10. Detection of anti-SAR408701 antibody

    Time frame: Up to an average of 10 months

    Immunogenicity evaluation for anti-SAR408701 antibodies

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Oct 27, 2017
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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