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

Part of paid clinical trials in East Brunswick, New Jersey.

Sponsor
AbbVie
Study ID
NCT07525206
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telisotuzumab adizutecan — DRUG
    Intravenous (IV)
  • Bevacizumab — DRUG
    Intravenous (IV)
  • Trifluridine/Tipiracil — DRUG
    Oral

Study Details

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 c-Met over-expressed 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 700 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.

Key Dates

Start date
May 22, 2026
Status verified
Jun 2026
Primary completion
May 31, 2029
Completion
Mar 31, 2030

Study Design

Enrollment
700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ph 3: Telisotuzumab Adizutecan + Bevacizumab
    Participants will receive telisotuzumab adizutecan + Bevacizumab as part of an approximately 36 months study duration.
  • Experimental: Ph 3: SOC Trifluridine and Tipiracil + Bevacizumab
    Participants will receive standard of care (SOC) trifluridine and tipiracil +Bevacizumab as part of an an approximately 36 months study duration.

Primary Outcome Measure

Phase 3: Objective Response (OR) as assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to Approximately 15 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Astera Cancer Care /ID# 279532East BrunswickNew Jersey08816-4096-

Find similar trials in East Brunswick, NJ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Astera Cancer Care· East Brunswick, NJ

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