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A Randomized, Open-label, Phase 2 study of Botensilimab (AGEN1181) as Monotherapy and in Combination with Balstilimab (AGEN2034) or Investigator’s Choice Standard of Care (Regorafenib or Trifluridine and Tipiracil) for the Treatment of Refractory Metastatic Colorectal Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502065-23-00
Acronym
C-800-25
Enrollment
102
Registered
2023-03-06
Start date
2023-06-01
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Refractory Metastatic Colorectal Cancer

Brief summary

ORR, defined as the proportion of patients with a complete response or partial response as assessed by RECIST 1.1 criteria.

Detailed description

01. DOR, defined as the time from initial objective radiographic response until disease progression or death, whichever occurs first., 02. PFS, defined as the time from randomization until disease progression or death, whichever occurs first., 03. OS, defined as the time from randomization until death due to any cause.

Interventions

DRUGBOTENSILIMAB
DRUGStivarga 40 mg film-coated tablets.
DRUGBALSTILIMAB

Sponsors

Agenus Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
ORR, defined as the proportion of patients with a complete response or partial response as assessed by RECIST 1.1 criteria.

Secondary

MeasureTime frame
01. DOR, defined as the time from initial objective radiographic response until disease progression or death, whichever occurs first., 02. PFS, defined as the time from randomization until disease progression or death, whichever occurs first., 03. OS, defined as the time from randomization until death due to any cause.

Countries

Belgium, France, Italy, Spain

Outcome results

None listed

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