Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors
- Conditions
- Neoplasm Malignant
- Interventions
- Registration Number
- NCT03324113
- Lead Sponsor
- Sanofi
- 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 (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.
- 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 around 30 days after the last administration of IMP, and at least one follow-up (FU) visit after the EOT visit.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SAR408701 Monotherapy SAR408701 SAR408701 Dose escalation administered as a single agent intravenously, on Day 1 and once every two weeks, to patients with malignant solid tumors SAR408701 Monotherapy diphenhydramine SAR408701 Dose escalation administered as a single agent intravenously, on Day 1 and once every two weeks, to patients with malignant solid tumors SAR408701 Monotherapy dexamethasone SAR408701 Dose escalation administered as a single agent intravenously, on Day 1 and once every two weeks, to patients with malignant solid tumors SAR408701 Monotherapy naphazoline SAR408701 Dose escalation administered as a single agent intravenously, on Day 1 and once every two weeks, to patients with malignant solid tumors
- Primary Outcome Measures
Name Time Method IMP-related dose limiting toxicities (DLT) 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 Outcome Measures
Name Time Method Time to reach maximum concentration (Tmax) of SAR408701 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
Assessment of anti-tumor activity Up to an average of 10 months Assessment of tumor response using standard imaging, as defined by RECIST 1.1 criteria
Treatment emergent adverse events 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
AUC of DM4 and Me-DM4 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
Assessment of PDy effect Up to an average of 10 months Assessment of plasma CEACAM5 levels in main dose-escalation part
Cmax of DM4 and Me-DM4 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
Detection of anti-SAR408701 antibody Up to an average of 10 months Immunogenicity evaluation for anti-SAR408701 antibodies
Area under the concentration-time curve (AUC) of SAR408701 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
Maximum observed concentration (Cmax) of SAR408701 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
Tmax of DM4 and Me-DM4 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
Trial Locations
- Locations (3)
Investigational Site Number 3920002
🇯🇵Nagoya-Shi, Japan
Investigational Site Number 3920003
🇯🇵Kashiwa-Shi, Japan
Investigational Site Number 3920001
🇯🇵Sunto-Gun, Japan