Study to Assess Adverse Events and Change in Disease Activity in Previously Treated Adult Participants Receiving Intravenous (IV) ABBV-400 With Unresectable Metastatic Colorectal Cancer in Combination With IV Fluorouracil, Folinic Acid, and Bevacizumab

Running, not enrolling · Phase 2

Conditions studied: Unresectable Metastatic Colorectal Cancer

In brief

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given in combination with Fluorouracil, Folinic Acid, and Bevacizumab to adult participants to treat unresctable metastatic colorectal cancer. ABBV-400 is an investigational drug being developed for the treatment of unresectable metastatic colorectal cancer. Fluorouracil, folinic acid, and bevacizumab (FFB) is an approved drug for the treatment of unresectable metastatic colorectal cancer. Study doctors put the participants in groups called treatment arms. Each treatment arm receives a different dose of ABBV-400 in combination with FFB in escalating doses on two different schedules (safety lead in), followed by low or high doses of ABBV-400 in combination with FFB or fluorouracil, folinic acid, irinotecan, and bevacizumab (standard of care \[SOC\]) \[dose optimization\] on its own, ending with low or high doses of ABBV-400 in combination with FFB for continued dose optimization and expansion. Approximately 280 adult participants with unresectable metastatic colorectal cancer will be enrolled in the study in 65 sites worldwide. In the safety lead in, participants will receive escalating intravenous (IV) ABBV-400 in combination with IV FFB on two different schedules. During the dose optimization participants will receive IV ABBV-400 in combination with IV FFB at low or high doses determined in the safety lead in. The dose optimization arm will also include a comparator cohort in which participants will receive SOC. During the dose optimization and expansion stage, participants will receive IV ABBV-400 in combination with IV FFB at low or high doses that have been determined from the previous stages. The study will run for a duration of approximately 3 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.

Key facts

Study ID

NCT06107413

Run by

AbbVie

People needed

280

Starts

2023-11-12

Expected to finish

2026-12-01

Last updated by the study team

2025-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of histologically or cytologically confirmed unresectable metastatic colorectal cancer (mCRC).
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Progressed on only one first-line (1L) systemic treatment of combination chemotherapy in the metastatic setting with or without targeted therapy.

You may not qualify if…

• Harbor the BRAF V600E mutation.
• dMMR+/MSI-H.
• Received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days or 5 half-lives of the drug (whichever is shorter) prior to the first dose of ABBV-400.

Where it is running

• City of Hope - Orange County Lennar Foundation Cancer Center /ID# 268365 — Irvine, California, United States
• Mayo Clinic Arizona /ID# 262610 — Phoenix, Arizona, United States
• Highlands Oncology Group, PA /ID# 259424 — Springdale, Arkansas, United States
• Yale School of Medicine /ID# 257494 — New Haven, Connecticut, United States
• Mayo Clinic Hospital Jacksonville /ID# 262609 — Jacksonville, Florida, United States
• University of Illinois Hospital and Health Sciences System /ID# 257300 — Chicago, Illinois, United States
• Northwestern Medicine - Northwestern Memorial Hospital /ID# 260563 — Chicago, Illinois, United States
• Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601 — Fort Wayne, Indiana, United States
• Indiana University Melvin and Bren Simon Cancer Center /ID# 258789 — Indianapolis, Indiana, United States
• Community Health Network, Inc. /ID# 257078 — Indianapolis, Indiana, United States
• Comprehensive Cancer Centers of Nevada /ID# 257642 — Henderson, Louisiana, United States
• Mayo Clinic - Rochester /ID# 257301 — Rochester, Minnesota, United States
• Atrium Health Levine Cancer Institute /ID# 258840 — Charlotte, North Carolina, United States
• Duke Cancer Institute /ID# 257236 — Durham, North Carolina, United States
• Oregon Health & Science University, Knight Cancer Institute- /ID# 259190 — Portland, Oregon, United States
• Medical University of South Carolina /ID# 258486 — Charleston, South Carolina, United States
• Avera Cancer Institute /ID# 257949 — Sioux Falls, South Dakota, United States
• MD Anderson Cancer Center /ID# 258713 — Houston, Texas, United States
• Texas Oncology PA /ID# 257780 — Houston, Texas, United States
• Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 257448 — Fairfax, Virginia, United States
• Virginia Cancer Specialists - Fairfax /ID# 257261 — Fairfax, Virginia, United States
• Imelda Ziekenhuis /ID# 257082 — Bonheiden, Antwerpen, Belgium
• Universitair Ziekenhuis Antwerpen /ID# 257080 — Edegem, Antwerpen, Belgium
• Cliniques Universitaires UCL Saint-Luc /ID# 257081 — Brussels, Brussels Capital, Belgium
• City of Hope National Medical Center /ID# 257576 — Duarte, California, United States

Full record on ClinicalTrials.gov

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