A Study of SAR428926 in Patients With Advanced Solid Tumors
- Registration Number
- NCT02575781
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objectives:
To determine the maximum tolerated dose (MTD) of SAR428926 when administered as a single agent in patients with advanced solid tumors.
To evaluate the anti-tumor response of SAR428926 when administered as a single agent in patients with advanced triple negative breast cancer (TNBC) positive for the protein targeted by SAR428926 To assess the preliminary anti-tumor response of SAR428926 when administered as a single agent in patients with advanced solid tumors positive for the protein targeted by SAR428926
Secondary Objectives:
To determine the overall safety profile of SAR428926 as a single agent. To characterize the pharmacokinetics (PK) profile of SAR428926 and its metabolites.
To identify the recommended Phase 2 dose (RP2D) of SAR428926 as a single agent. To evaluate the immunogenicity of SAR428926. To assess the tumor response and duration of tumor response in all treated patients.
To evaluate the benefit of primary prophylaxis on the occurrence of corneal (keratopathy/keratitis) toxicity (Expansion cohorts).
- Detailed Description
The study duration for an individual patient will include a screening period for inclusion of up to 28 days, a treatment period, an end-of-treatment (EOT) visit around 30 days following the last administration of SAR428926, and at least one follow-up visit around 30 days after the EOT visit. The treatment period may continue until disease progression, intolerable toxicity, or investigator, Sponsor, or patient decision to discontinue therapy. Patients who discontinue treatment for reasons other than progression of disease will be followed every 3 months until progression, initiation of subsequent therapy, or until the primary analysis cutoff date, whichever comes first.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SAR428926 in solid tumors-Expansion Cohort 2 SAR428926 SAR428926 will be administered intravenously at the MTD up to disease progression or unacceptable toxicity SAR428926-Escalating cohort SAR428926 SAR428926 will be administered intravenously up to disease progression or dose limiting toxicities SAR428926 in triple negative breast cancer-Expansion Cohort 1 SAR428926 SAR428926 will be administered intravenously at maximum tolerated dose (MTD) up to disease progression or unacceptable toxicity
- Primary Outcome Measures
Name Time Method Number of patients with dose limiting adverse events (Escalation cohort) 4 weeks Number of patients with corneal adverse events impacting study treatment (Escalation cohort) 8 weeks Assessment of overall response rate using standard imaging and RECIST v1.1 criteria (Expansion cohort) Tumor assessment every 2 months until disease progression or up to 36 months, whichever came first
- Secondary Outcome Measures
Name Time Method Assessment of PK parameter: accumulation ratio on AUC0-14 2 months Number of treatment emergent adverse events Up to 3 years Assessment of PK parameter: maximum concentration (Cmax) 2 months Assessment of PK parameter: trough plasma concentration (Ctrough) Every 2 weeks until approximately 14 weeks Assessment of PK parameter: area under the plasma concentration curve versus time curve between 1 and 14 days (AUC0-14 day) 2 months Assessment of PK parameter: clearance at steady state (CLss) 2 months Assessment of PK parameter: time to reach maximum concentration (tmax) 2 months Assessment of PK parameter: mean systemic clearance (CL) 2 months Assessment of PK parameter: accumulation ratio on Cmax 2 months Preliminary tumor response by RECIST v1.1 (Escalation) 2 months Number of corneal events according to the presence or not of preventive measures 12 weeks
Trial Locations
- Locations (3)
Investigational Site Number 2080001
🇩🇰København Ø, Denmark
Investigational Site Number 7240001
🇪🇸Barcelona, Spain
Investigational Site Number 2500001
🇫🇷Villejuif Cedex, France