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
Public ClinicalTrials.gov record NCT06820463. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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, questionnaires and side effects.
Study identification
- NCT ID
- NCT06820463
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 390 participants
Conditions and interventions
Conditions
Interventions
- Telisotuzumab Adizutecan Drug
- Fluorouracil Drug
- Oxaliplatin Drug
- Leucovorin Drug
- Bevacizumab Drug
- Panitumumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 23, 2025
- Primary completion
- Feb 29, 2028
- Completion
- Mar 31, 2028
- Last update posted
- Sep 1, 2026
2025 – 2028
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center /ID# 270255 | Duarte | California | 91010 | Recruiting |
| UCLA - Santa Monica /ID# 270621 | Santa Monica | California | 90404 | Recruiting |
| Yale New Haven Hospital /ID# 270565 | New Haven | Connecticut | 06510 | Recruiting |
| AdventHealth Orlando /ID# 270789 | Orlando | Florida | 32803 | Recruiting |
| Northwest Georgia Oncology Centers /ID# 270245 | Marietta | Georgia | 30060 | Recruiting |
| University of Chicago Medical Center /ID# 271688 | Chicago | Illinois | 60637 | Recruiting |
| Hope And Healing Cancer Services /ID# 271562 | Hinsdale | Illinois | 60521 | Recruiting |
| Dana-Farber Cancer Institute /ID# 270624 | Boston | Massachusetts | 02215 | Recruiting |
| University Of Michigan /ID# 270790 | Ann Arbor | Michigan | 48109-5000 | Recruiting |
| Saint Lukes Hospital of Kansas City /ID# 270633 | Kansas City | Missouri | 64111 | Recruiting |
| Nebraska Cancer Specialists - Omaha - Wright Street /ID# 271646 | Omaha | Nebraska | 68130 | Recruiting |
| University of North Carolina Medical Center /ID# 267786 | Chapel Hill | North Carolina | 27514 | Recruiting |
| Oncology Hematology Care - Eastgate /ID# 271493 | Cincinnati | Ohio | 45245 | Recruiting |
| Texas Oncology - Austin Midtown /ID# 271354 | Austin | Texas | 78705 | Recruiting |
| Texas Oncology - Deke Slayton Cancer Center /ID# 271355 | Webster | Texas | 77598 | Recruiting |
| Virginia Cancer Specialists - Fairfax /ID# 271351 | Fairfax | Virginia | 22031 | Recruiting |
| University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 271298 | Seattle | Washington | 98109 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06820463, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 1, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06820463 live on ClinicalTrials.gov.