A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
← catalyst calendarNCT05584670 · readout in 152 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
542estimated
Sites
22
Countries
Chile, Israel, Japan +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-11-29 | actual | When the study began enrolling |
| Primary completion | 2027-01-19 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-06-28 | estimated | The whole study's end, after follow-up |
| First posted | 2022-10-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Solid Tumor
Interventions
- Drug: SAR445877
- Drug: Cetuximab — also filed as Erbitux
- Drug: ADG126
- Drug: Bevacizumab — also filed as bevacizumab-bvzr, Zirabev®
- Drug: Nivolumab — also filed as Opdivo®
- Drug: Ipilimumab — also filed as Yervoy®
Primary outcomes
what the primary-completion date above is the date OFDose escalation part 1A, 1C and Japan Cohort F: Presence of dose-limiting toxicities (DLTs) in Cycles 1 and 2
measured Cycles 1 & 2 - 14 days per cycle
Dose escalation part 1B: Presence of dose-limiting toxicities (DLTs) in Cycle 1 to 3 in part B
measured Cycle 1 to 3 -14 days per cycle
Dose escalation and Japan Cohort F: Percentage of participants experiencing treatment-emergent adverse events (TEAEs)
measured The time from the first dose of study interventions up to 30 days after last dose of study interventions
Dose expansion/optimization: Objective response rate (ORR)
measured From baseline to the end of dose expansion/optimization (up to 2 years)
Permalink · SNY's whole pipeline · Catalyst calendar · Every registered study · What changed