Evaluation of SAR408701 in Patients With Advanced Solid Tumors
- Registration Number
- NCT02187848
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objectives:
* To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W).
* To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle).
* To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without a loading dose at Cycle 1.
Secondary Objectives:
* To characterize the overall safety profile of SAR408701.
* To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential circulating derivatives.
* To identify the recommended phase 2 dose (RP2D) of SAR408701.
* To assess the potential immunogenicity of SAR408701.
- Detailed Description
The study duration for an individual patient will start from the signature of the informed consent, 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 visit around 30 days following the last administration of study drug, and at least one follow-up visit after the end-of-treatment visit. Additional follow-up visits may be required until resolution or stabilization of adverse events (at least 30 days). Treatment may continue until precluded by toxicity, progression, or upon patient's request. If the patient stops study treatment for reason other than disease progression, follow-up visit will be performed every 3 months until disease progression or initiation of another anti-tumor treatment or death, whichever comes first.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 254
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR408701 Expansion Cohort gastric adenocarcinoma SAR408701 Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing gastric adenocarcinoma SAR408701 Loading Dose Escalation cohorts (Escalation bis) SAR408701 Loading dose escalation administered intravenously at first cycle, followed by MTD, once every 2 weeks SAR408701 Expansion Cohort non-squamous NSCLC (Lung bis) SAR408701 Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing non-squamous NSCLC of at least 1% but below 50% of tumor cells at or above 2+ intensity SAR408701 Main Dose Escalation Cohort SAR408701 Dose escalation administered intravenously, once every two weeks SAR408701 Expansion Cohort colorectal cancer (CRC) SAR408701 Administered intravenously at the maximum tolerated dose (MTD), once every 2 weeks, to patients with colorectal cancer SAR408701 Expansion Cohort non-squamous NSCLC SAR408701 Administered intravenously at the MTD, once every 2 weeks, to patients with carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expressing non-squamous non-small cell lung cancer (NSCLC) of at least 50% of tumor cells at or above 2+ intensity SAR408701 Expansion Cohort colorectal cancer (CRC-L) SAR408701 Loading dose of determined MTD-L administered intravenously at first cycle, followed by MTD, once every 2 weeks SAR408701 Expansion Cohort small cell lung cancer (SCLC) SAR408701 Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing SCLC SAR408701 Dose Escalation every 3 weeks cohort SAR408701 Dose escalation administered intravenously, once every three weeks
- Primary Outcome Measures
Name Time Method Number of dose limiting adverse events (every 2 week cycle) 4 weeks Assessment of overall response rate using standard imaging and RECIST 1.1 criteria Up to 40 months Number of dose limiting adverse events (every 3 week cycle) 3 weeks
- Secondary Outcome Measures
Name Time Method Duration of response Up to 40 months - assessment every 6-8 weeks Number of treatment emergent adverse events Up to 4 years Maximum concentration (Cmax) 2 months Time to reach maximum concentration (tmax) 2 months Trough plasma concentrations (Ctrough) Intensive testing within first 2 months, then every 2 weeks Accumulation ratio (Rac) on AUC0-14day and Cmax 2 months Area under the plasma concentration versus time curve between 0 and 14 days (AUC0-14day) for Q2W or between 0 and 21 days (AUC-21 day) for Q3W 2 months Mean systemic clearance (CL) 2 months Clearance at steady state (CLss) 2 months Detection of the development of anti-SAR408701 antibody Up to 40 months Time to Progression Up to 40 months - assessment every 6-8 weeks
Trial Locations
- Locations (20)
Dana Farber Cancer Institute- Site Number : 840005
🇺🇸Boston, Massachusetts, United States
Yale University School of Medicine Site Number : 840002
🇺🇸New Haven, Connecticut, United States
Investigational Site Number : 124001
🇨🇦Toronto, Ontario, Canada
Investigational Site Number : 250003
🇫🇷Bordeaux Cedex, France
Investigational Site Number : 250006
🇫🇷Dijon, France
Investigational Site Number : 250004
🇫🇷Marseille, France
Investigational Site Number : 250007
🇫🇷Rennes, France
Investigational Site Number : 250005
🇫🇷Saint Mande, France
Investigational Site Number : 250002
🇫🇷TOULOUSE Cedex 9, France
Investigational Site Number : 250001
🇫🇷Villejuif, France
Investigational Site Number : 410002
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 410005
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 410003
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 410004
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 410001
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 724001
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 724004
🇪🇸Madrid / Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 724003
🇪🇸Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 724002
🇪🇸Majadahonda, Madrid, Spain
Investigational Site Number : 724006
🇪🇸Madrid, Spain