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NCT06820463 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer
A Phase 2 study of Metastatic Colorectal Cancer, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 390
- Enrollment target
- 20
- Study locations
NCT06820463: Recruiting Phase 2 study of Metastatic Colorectal Cancer, sponsored by AbbVie.
NCT06820463 is a Phase 2 study of Metastatic Colorectal Cancer that is actively recruiting participants, run by AbbVie. The registered enrollment target is 390 participants, above the 177-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (120% higher). The trial reports 20 study locations across 19 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06820463, a Phase 2 study of Metastatic Colorectal Cancer, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 390 participants
- Enrollment target
- 20
- Study locations
Study Summary
CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU/LV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU/LV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU/LV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab/pantitumumab. The study will run for a duration of approximately 6 years. 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, questionna
Primary Outcome
OR is defined as confirmed CR or PR as assessed by the investigator per RECIST, version 1.1.
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Telisotuzumab Adizutecan
- DRUG Oxaliplatin
Study Locations (20)
Texas
- Texas Oncology - Austin Midtown /ID# 271354 - Austin
- Texas Oncology - Deke Slayton Cancer Center /ID# 271355 - Webster
California
- City of Hope National Medical Center /ID# 270255 - Duarte
Connecticut
- Yale New Haven Hospital /ID# 270565 - New Haven
Illinois
- Hope And Healing Cancer Services /ID# 271562 - Hinsdale
Massachusetts
- Dana-Farber Cancer Institute /ID# 270624 - Boston
Missouri
- Saint Lukes Hospital of Kansas City /ID# 270633 - Kansas City
Nebraska
- Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646 - Omaha
North Carolina
- University of North Carolina Medical Center /ID# 267786 - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2025-04-24 |
| Est. Completion | 2028-04 |
| Phase | Phase 2 |
What NCT06820463 shows while recruiting
NCT06820463 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, above the 177-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (120% higher).
The record links to 1 condition, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Bevacizumab is the first listed.
NCT06820463 names 20 study sites across 19 states, led by Texas, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06820463 about?
NCT06820463 is a clinical study titled "A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer". CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (...
What is the current status of trial NCT06820463?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 390 participants. The study started on 2025-04-24. Estimated completion is 2028-04.
What conditions does trial NCT06820463 study?
This clinical trial studies the following conditions: Metastatic Colorectal Cancer.
What interventions are being tested in trial NCT06820463?
The interventions under investigation include: Bevacizumab (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), Telisotuzumab Adizutecan (DRUG), Oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT06820463?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06820463 being conducted?
This trial has 20 study locations across California, Connecticut, Illinois, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06820463's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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