Status:
COMPLETED
Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors
Lead Sponsor:
Sanofi
Conditions:
Neoplasm Malignant
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief 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 (DL...
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 aroun...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03324113
Start Date
October 17 2017
End Date
December 26 2022
Last Update
August 5 2025
Active Locations (3)
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1
Investigational Site Number : 3920002
Nagoya, Aichi-ken, Japan, 464-8681
2
Investigational Site Number : 3920003
Kashiwa-shi, Chiba, Japan, 277-8577
3
Investigational Site Number : 3920001
Sunto-gun, Shizuoka, Japan, 411-8777