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A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects with Metastatic Colorectal Cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512915-33-00
Acronym
XL092-303
Enrollment
328
Registered
2024-07-31
Start date
2022-12-22
Completion date
Unknown
Last updated
2026-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Brief summary

Overall Survival

Detailed description

PFS as assessed by the investigator per RECIST 1.1, ORR as assessed by the investigator per RECIST 1.1, DOR as assessed by the investigator per RECIST 1.1, Incidence and severity of Es, SAEs and adverse events of special interest (AESIs), Plasma concentration of XL092 given in combination with atezolizumab, serum concentration of atezolizumab given in combination with XL092, the incidence of antidrug antibody (ADA) response against atezolizumab given in combination with XL092.

Interventions

DRUGXL092
DRUGTecentriq 1 200 mg concentrate for solution for infusion

Sponsors

Exelixis Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall Survival

Secondary

MeasureTime frame
PFS as assessed by the investigator per RECIST 1.1, ORR as assessed by the investigator per RECIST 1.1, DOR as assessed by the investigator per RECIST 1.1, Incidence and severity of Es, SAEs and adverse events of special interest (AESIs), Plasma concentration of XL092 given in combination with atezolizumab, serum concentration of atezolizumab given in combination with XL092, the incidence of antidrug antibody (ADA) response against atezolizumab given in combination with XL092.

Countries

Belgium, France, Germany, Hungary, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026