A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer
Secondary endpoints: details revised at 3 of 5 entries
MinorEnrollment increased: 700 → 990 participantsv20Show 4 more changesShow less
Trial sites expanded: 62 → 69 locations
Trial sites expanded: 35 → 62 locations
Eligibility criteria expanded, about 18 words
Secondary endpoints revised (5)
MinorTrial sites expanded: 32 → 35 locations
Trial sites expanded: 27 → 32 locations
v19
MinorStudy sites: 27 to 32v18
MinorTrial sites expanded: 21 → 25 locationsv17
MinorStudy sites: 25 to 26v16
MinorStudy sites: 21 to 25v15
MinorStudy sites: 19 to 21v14
MinorStudy sites: 18 to 19v13
MinorStudy sites: 17 to 18v12
MinorStudy sites: 16 to 17v11
MinorTrial sites expanded: 10 → 13 locationsv10
MinorStudy sites: 13 to 14v9
MinorStudy sites: 10 to 13v8
MinorStudy sites: 9 to 10v7
MinorRe-verified, no change to tracked fieldsv6
MinorStudy sites: 8 to 9v5
MinorStudy completion pushed from May 2029 to Mar 2030
Study sites: 7 to 8
v4
NotableRecruitment opened
Trial sites expanded: 0 → 6 locations
Study completion date: May 2029 to Mar 2030
v3
NotableTrial status: Not Yet Recruiting to Recruiting
Study sites: 0 to 6
Start date changed from estimate of May 7, 2026 to May 22, 2026
v2
MinorStudy First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with refractory metastatic colorectal cancer (mCRC).
Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 990 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally.
In this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine/tipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 months.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.