Tovecimig plus FOLFIRI in second line metastatic colorectal cancer
11 evidence topics · 2 sources
Objective
Location and study date
Study dates, status, and site: registry record
| Milestone | Registry record |
|---|---|
| Study start (estimated) | “2026-08-31” |
| Primary completion (estimated) | “2030-08-31” |
| Enrollment (estimated) | “25” |
| Recruitment status | “Not yet recruiting” |
| Last update posted | “2026-06-23” |
Study design
Single-group open-label phase 2 design
Sponsor description of the investigator-sponsored trial
Eligibility criteria
Key inclusion criteria: registry record
| Criterion | Quoted registry text |
|---|---|
| Diagnosis | “Histologically or cytologically confirmed CRC.” |
| Prior therapy | “Patient must have advanced or metastatic disease, and have progressed on one line of standard of care therapy in the advanced/metastatic setting” |
| Measurable disease | “Measurable disease per RECIST 1.1.” |
| Age | “At least 18 years of age.” |
| Performance status | “ECOG performance status ≤ 2” |
Treatment
Study outcomes
Rationale for using overall response rate as the primary endpoint
Registered primary outcome measure
Justification of the primary endpoint
Not applicable.
Statistical analysis description
Number of participants (Planned and analyzed)
Planned enrollment
Description of analysis sets
No evidence found.
Results
Participant disposition
No evidence found.
Baseline characteristics
No evidence found.
Efficacy results
No evidence found.
Health-related quality of life and patient-reported outcomes
Registered performance-status outcome measure
Reported quality-of-life results
No evidence found.
Safety results
No evidence found.
Study limitations
Summary
This is an investigator-sponsored, open-label, single-group phase 2 trial at one institution with an estimated enrollment of 25 participants, in metastatic colorectal cancer rather than biliary tract cancer. As of the June 23, 2026 registry update it was not yet recruiting, with an estimated start of August 31, 2026 and estimated primary completion of August 31, 2030, so no results exist. The single-group design without a comparator means the primary outcome of overall response rate cannot be attributed to the addition of tovecimig to FOLFIRI, and the planned quality-of-life measure is change in Eastern Cooperative Oncology Group performance status rather than a patient-reported instrument.