A Phase 1b Dose-escalation Study of the Safety and Pharmacokinetics of SAR245408 Administered in Combination With SAR256212 in Patients With Solid Tumor Cancers
Overview
- Phase
- Phase 1
- Intervention
- MM-121 (SAR256212)
- Conditions
- Solid Tumor Cancers
- Sponsor
- Sanofi
- Enrollment
- 26
- Locations
- 3
- Primary Endpoint
- Maximum tolerated dose
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Primary Objective:
- To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of SAR245408 administered in combination with SAR256212 in adult patients with locally advanced or metastatic solid tumors.
Secondary Objectives:
- To characterize the global safety profile of SAR245408 in combination with SAR256212
- To evaluate the pharmacokinetic (PK) profile of SAR245408 and SAR256212 used in combination
- To evaluate the objective response rate (ORR) and tumor volume change (for expansion cohort only)
- To determine the immunogenicity of SAR256212 as administered with SAR245408
Detailed Description
There is a 28 day screening period followed by 28 day cycles (21 day cycle for the every three week dosing regimen, if used) . Patients will continue to receive SAR245408/SAR256212 as long as there is clinical benefit or until a study withdrawal criterion is met. The last posttreatment visit will be 60 days after the last dose or until IMP-related toxicities have resolved or are deemed irreversible, whichever is later.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
dose escalation and expansion
SAR245408 taken every day in the morning: no eating 2 hours prior and 1 hour after dose; SAR256212 will be given weekly by IV infusion over 1 hour, right after the SAR245408 oral dose
Intervention: MM-121 (SAR256212)
dose escalation and expansion
SAR245408 taken every day in the morning: no eating 2 hours prior and 1 hour after dose; SAR256212 will be given weekly by IV infusion over 1 hour, right after the SAR245408 oral dose
Intervention: SAR245408
Outcomes
Primary Outcomes
Maximum tolerated dose
Time Frame: 2 months to 12 months
Secondary Outcomes
- overall response rate(2 months to 2 years)
- Pharmacodynamic change in ErbB3 protein and mRNA levels as well as components of the PI3K pathway will be measured(1 month to 6 months)
- Number of patients who develop anti-MM-121 antibodies(1 month to 6 months)
- Peak and trough levels of SAR256212 and SAR245408(1 month to 6 months)
- Number of participants with adverse events(1 month to 2 years)