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A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease
NCT07023289 · View on ClinicalTrials.gov ↗
Study Summary
Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess change in disease activity when telisotuzumab adizutecan is given alone compared to standard of care (SOC) given alone. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. This study will be divided into two groups called treatment arms. In arm 1 participants will receive telisotuzumab adizutecan alone. In arm 2 participants will receive SOC alone. Approximately 140 adult participants with CRC will be enrolled in the study in 45 sites worldwide. In arm 1, participants will receive intravenous (IV) doses of telisotuzumab adizutecan alone. In arm 2 Participants will receive SOC alone. The study will run for a duration of approximately 51 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.
Conditions Studied
Interventions
- DRUG Telisotuzumab Adizutecan
- DRUG Standard of Care
Study Locations (20)
Texas
- Texas Oncology - Central/South Texas /ID# 275154 — Austin
- The Center For Cancer And Blood Disorders /ID# 278512 — Fort Worth
- Texas Oncology-Grapevine /ID# 275155 — Grapevine
- The University of Texas MD Anderson Cancer Center /ID# 273539 — Houston
California
- Providence Medical Foundation /ID# 274207 — Fullerton
- USC Norris Comprehensive Cancer Center /ID# 274550 — Los Angeles
Florida
- Mayo Clinic Hospital Jacksonville /ID# 274472 — Jacksonville
- Moffitt Cancer Center /ID# 274372 — Tampa
Minnesota
- Scri Minnesota Oncology Hematology, P.A. /ID# 275149 — Minneapolis
- Mayo Clinic-Rochester /ID# 273508 — Rochester
Virginia
- Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 274586 — Fairfax
- Virginia Cancer Specialists - Fairfax /ID# 274339 — Fairfax
Alabama
- Clearview Cancer Institute - Huntsville - Cci Drive /ID# 278621 — Huntsville
Illinois
- University of Chicago Medical Center /ID# 274742 — Chicago
Maryland
- Johns Hopkins Hospital /ID# 275645 — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2025-08-07 |
| Est. Completion | 2029-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07023289
The ClinicalTrials.gov registry entry for NCT07023289 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 2 interventions — of which Telisotuzumab Adizutecan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07023289 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Texas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07023289 about?
NCT07023289 is a clinical study titled "A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease". Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess change in disease activity when telisotuzumab adizutecan is given alone compared to standard of care (SOC) given alone. Telisotuzumab adizutecan is an investigational drug bei...
What is the current status of trial NCT07023289?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2025-08-07. Estimated completion is 2029-11.
What conditions does trial NCT07023289 study?
This clinical trial studies the following conditions: Colorectal Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07023289?
The interventions under investigation include: Telisotuzumab Adizutecan (DRUG), Standard of Care (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07023289?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07023289 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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