Clinical trial · Interventional
Phase I, Dose Escalation of SAR125844 in Asian Solid Tumor Patients
Phase I, Dose Escalation Study of Safety, Pharmacokinetic and Pharmacodynamic of SAR125844 Administered Weekly as Intravenous Infusion in Asian Adult 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: In the dose escalation: to determine the maximum tolerated dose (MTD) of SAR125844. In the expansion cohort: to evaluate the preliminary anti-tumoral effect of SAR125844 in patients with measurable and MET gene amplification (including gastric cancer patients). Secondary Objectives: To characterize and confirm the global safety profile of SAR125844 including cumulative toxicities. To assess preliminary antitumor activity of SAR125844. To explore the pharmacodynamic effects (PDy) of SAR125844. To evaluate the pharmacokinetic profile of SAR125844. To explore the relationship of MET gene amplification status with antitumor effects. To evaluate other pharmacodynamic biomarkers.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SAR125844 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalation
- description
- SAR125844 will be administered as weekly IV infusion. Four weekly administrations are considered as 1 cycle. The starting dose will be either 1 dose level (DL) below the highest cleared dose level in a European TED11449 ongoing study or DL4 (260 mg/m\^2), if the highest cleared dose in TED11449 is \>340 mg/m\^2.
- interventionNames
- Drug: SAR125844
Primary outcomes (2)
- measure
- - DOSE ESCALATION To determine the maximum tolerated dose (MTD) of SAR125844
- timeFrame
- At d28 of Cycle 1 of each treated patient, DLT is assessed
- measure
- - EXPANSION Cohort To evaluate the preliminary anti-tumoral effect of SAR125844
- timeFrame
- Antitumor activity is assessed at the end of Cycle 1, then every 2 cycles up to treatment discontinuation
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion criteria: * Patients with solid tumor for which no standard therapy is available. * At the recommended dose (expansion cohort): only patients with measurable disease and MET gene amplification. Exclusion criteria: * Patient less than 20 years old. * ECOG performance status \>2. * Poor bone marrow reserve as defined by absolute neutrophils count \<1.5 x 10\^9/L or platelets \<100 x 10\^9/L. * Poor organ function as defined by one of the following: * Total bilirubin \>1.5 x ULN. * AST, ALT, alkaline phosphatase \>2.5 x ULN or \>5 x ULN in case of documented liver metastasis. * Serum creatinine \>1.5 x ULN, or serum creatinine between 1.0 and 1.5 x ULN associated with calculated creatinine clearance \<60 mL/min. * Proteinuria \>500mg/24h. * Pregnant or breast-feeding women. * Sexually active (males and females) who do not agree to use medically acceptable methods of contraception during the course of the study and for 3 months following discontinuation of study drug. * Female patients of childbearing potential must have a negative pregnancy test at screening. * Known or symptomatic brain metastasis (other than totally resected or previously pre-irradiated and no progressive/relapsing) or lepto-meningeal carcinomatosis. * No resolution of any specific toxicities (excluding alopecia) related to any prior anti-cancer therapy to grade ≤1 according to the NCI CTCAE v.4.03. * Wash out period of less than 3 weeks from previous antitumor therapy or any investigational treatment,(and less than 6 weeks in case of prior nitrozo-urea and or mitomycin C treatment). * Any surgery with major risk of bleeding performed less than 10 days prior to study treatment administration. * Any other severe underlying medical conditions, which could impair the ability to participate in the study. * Patients treated with potent CYP3A inhibitor. * Patients treated with potent and moderate CYP3A inducers. * Known hypersensitivity or any adverse event related to the study drug excipient (Captisol®). * Prior treatment with any MET inhibitor compound (selective or not). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available