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 (NCT07525206)
An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Astera Cancer Care /ID# 279532 — East Brunswick, New Jersey
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (35 Sites)
Showing the first 25 of 35 sites.
- Astera Cancer Care /ID# 279532 — East Brunswick, New Jersey
- Northwell Health Center for Advanced Medicine. /ID# 279590 — Lake Success, New York
- Compass Oncology - Rose Quarter /ID# 280127 — Portland, Oregon
- University Of Washington-Fred Hutchinson Cancer Center - Seattle /ID# 281451 — Seattle, Washington
- Imelda Ziekenhuis /ID# 279333 — Bonheiden, Antwerpen
- Algemeen Ziekenhuis klina /ID# 279331 — Brasschaat, Antwerpen
- Universitair Ziekenhuis Antwerpen /ID# 279334 — Edegem, Antwerpen
- Institut Jules Bordet /ID# 279406 — Anderlecht, Brussels Capital
- Grand Hopital de Charleroi - Les Viviers /ID# 279336 — Charleroi, Hainaut
- AZ Maria Middelares /ID# 280141 — Ghent, Oost-Vlaanderen
- AZ-Delta. /ID# 279329 — Roeselare, West-Vlaanderen
- Athens Medical Center - Psychikon Branch /ID# 279134 — Athens, Attica
- National Cancer Center Hospital East /ID# 279917 — Kashiwa-shi, Chiba
- National Hospital Organization Shikoku Cancer Center /ID# 280224 — Matsuyama, Ehime
- Kobe City Medical Center General Hospital /ID# 280233 — Kobe, Hyōgo
- Unidade Local de Saude do Alto Ave, EPE /ID# 279703 — Guimarães, Braga District
- Unidade Local de Saude de Loures-Odivelas /ID# 279636 — Loures, Lisbon District
- Unidade Local de Saude de Almada-Seixal, EPE /ID# 279637 — Almada, Setúbal District
- Unidade Local de Saude de Santa Maria /ID# 279624 — Lisbon,
- Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 279702 — Porto,
- Dong-A University Medical Center /ID# 279610 — Busan, Busan Gwang Yeogsi
- Gachon University Gil Medical Center /ID# 279592 — Incheon, Gyeonggido
- CHA Bundang Medical Center /ID# 279589 — Seongnam, Gyeonggido
- The Catholic University Of Korea St. Vincent's Hospital /ID# 279675 — Suwon, Gyeonggido
- Hospital de la Santa Creu i Sant Pau /ID# 279642 — Barcelona,
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Colorectal Cancer
- Impact of Colorectal Cancer and Nutrition Education Program Among Minority Patients With Type 2 Diabetes — Los Angeles, California
- A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors — Duarte, California
- Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD) — Houston, Texas
- Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver — Basking Ridge, New Jersey
- The PRIME-CRC Trial to Promote CRC Screening in Rural Communities — Bastrop, Louisiana
- Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer — Concord, California
Explore by condition: All Colorectal Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.