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
NCT06107413
Phase
Phase 2
Recruitment status
Active, not recruiting
Participants
Lead sponsor
AbbVie
Start date
2023-11-12
Number of sites
- Summary
- 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.
- Short title
- 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
- Official title
- A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Folinic Acid, and Bevacizumab and to Evaluate Safety and Efficacy of ABBV-400 in Combination With Bevacizumab in Previously Treated Subjects With Unresectable Metastatic Colorectal Cancer
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2026-12-01
- First posted
- 2023-10-30
- Registry last updated
- 2025-12-12
- Primary completion date
- 2026-12-01
- Start date
- 2023-11-12
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- AbbVie
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06107413
- ClinicalTrials.gov ID
- NCT06107413
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Percentage of Participants with Objective Response
Timeframe: Up to 24 Weeks
OR is defined as complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, as assessed by the investigator.
Progression Free Survival (PFS)
Timeframe: Up to 11 Months
PFS is defined as the time from the first dose of study drug to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by the investigator or death from any cause, whichever occurs earlier.
Number of Participants with Adverse Events (AEs)
Timeframe: Up to 3 Years
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Duration of Response (DOR)
Timeframe: Up to 7 Months
DOR is defined as The time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by the investigator or death from any cause, whichever occurs first.
Overall Survival (OS)
Timeframe: Up to 3 Years
OS is defined as the time from first dose of study drug to the event of death from any cause.
Percentage of Participants Achieving Best Overall Response (BOR)
Timeframe: Up to 18 Weeks
BOR is defined as confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, version 1.1 as determined by the investigator.
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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.
Sources for eligibility
- Mayo Clinic Arizona /ID# 262610Phoenix, United States
- Highlands Oncology Group, PA /ID# 259424Springdale, United States
- City of Hope National Medical Center /ID# 257576Duarte, United States
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 268365Irvine, United States
- Yale School of Medicine /ID# 257494New Haven, United States
- Mayo Clinic Hospital Jacksonville /ID# 262609Jacksonville, United States
- University of Illinois Hospital and Health Sciences System /ID# 257300Chicago, United States
- Northwestern Medicine - Northwestern Memorial Hospital /ID# 260563Chicago, United States
- Fort Wayne Medical Oncology and Hematology- South Office /ID# 259601Fort Wayne, United States
- Indiana University Melvin and Bren Simon Cancer Center /ID# 258789Indianapolis, United States
- Community Health Network, Inc. /ID# 257078Indianapolis, United States
- Comprehensive Cancer Centers of Nevada /ID# 257642Henderson, United States
- Mayo Clinic - Rochester /ID# 257301Rochester, United States
- Atrium Health Levine Cancer Institute /ID# 258840Charlotte, United States
- Duke Cancer Institute /ID# 257236Durham, United States
- Oregon Health & Science University, Knight Cancer Institute- /ID# 259190Portland, United States
- Medical University of South Carolina /ID# 258486Charleston, United States
- Avera Cancer Institute /ID# 257949Sioux Falls, United States
- MD Anderson Cancer Center /ID# 258713Houston, United States
- Texas Oncology PA /ID# 257780Houston, United States
- Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 257448Fairfax, United States
- Virginia Cancer Specialists - Fairfax /ID# 257261Fairfax, United States
- Imelda Ziekenhuis /ID# 257082Bonheiden, Belgium
- Universitair Ziekenhuis Antwerpen /ID# 257080Edegem, Belgium
- Cliniques Universitaires UCL Saint-Luc /ID# 257081Brussels, Belgium
And 39 more, listed on the interactive page.
Sources for sites
- 2023
- 2023-505110-14
Sources for references
Related records
Drugs (4)
Lead sponsors (1)
Conditions (1)
- Colorectal cancer Primary condition