Clinical trial · Interventional
Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors
A Phase I Study to Evaluate Safety and Pharmacokinetics of SAR408701 Administered Intravenously as Monotherapy in Japanese Patients With Advanced Malignant Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Malignant | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| diphenhydramine | Drug | — | UNRESOLVED |
| naphazoline | Drug | — | UNRESOLVED |
| SAR408701 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SAR408701 Monotherapy
- description
- SAR408701 Dose escalation administered as a single agent intravenously, on Day 1 and once every two weeks, to patients with malignant solid tumors
- interventionNames
- Drug: SAR408701
- Drug: dexamethasone
- Drug: naphazoline
- Drug: diphenhydramine
Primary outcomes (1)
- measure
- IMP-related dose limiting toxicities (DLT)
- timeFrame
- 4 weeks, Dose escalation q3w part: 3 weeks
- description
- 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 (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTMuro 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. PMID 40413667