ABBV-400 + Chemotherapy for Colorectal Cancer
Recruiting in Palo Alto (17 mi)
+57 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: AbbVie
Must be taking: Fluorouracil, Folinic acid, Bevacizumab
Must not be taking: Anticancer therapy
Disqualifiers: BRAF V600E mutation, dMMR+/MSI-H, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial tests a new drug, ABBV-400, combined with three existing drugs to treat advanced colorectal cancer in adults. It aims to find the best dose that controls cancer growth and minimizes side effects. The study involves regular hospital visits and various medical tests.
Will I have to stop taking my current medications?
The trial requires that you have not received any anticancer therapy, including chemotherapy, radiation, immunotherapy, biologic, or investigational therapy, within 28 days or 5 half-lives of the drug (whichever is shorter) before starting ABBV-400. This means you may need to stop certain medications before joining the trial.
What data supports the effectiveness of the drug ABBV-400 + Chemotherapy for Colorectal Cancer?
Research shows that bevacizumab, when combined with chemotherapy drugs like irinotecan, fluorouracil, and leucovorin, provides a survival benefit in metastatic colorectal cancer. This suggests that similar combinations, like those in the ABBV-400 trial, may also be effective.
12345What safety data exists for ABBV-400 and related treatments in colorectal cancer?
Bevacizumab, used in combination with chemotherapy for colorectal cancer, has been associated with side effects like gastrointestinal perforation (a hole in the stomach or intestines), bleeding, blood clots, and protein in the urine. However, in some studies, it was generally well-tolerated with no specific adverse reactions directly linked to bevacizumab. Irinotecan and 5-fluorouracil, often used together, have shown safety in treating colorectal cancer, with manageable side effects.
35678What makes the drug ABBV-400 + Chemotherapy unique for colorectal cancer?
The drug ABBV-400 combined with chemotherapy is unique because it includes Telisotuzumab adizutecan (ABBV-400), which is not a standard component in existing colorectal cancer treatments. This combination may offer a novel approach by potentially targeting cancer cells differently compared to traditional regimens like FOLFOX or FOLFIRI, which are commonly used with bevacizumab.
12349Eligibility Criteria
Adults with confirmed unresectable metastatic colorectal cancer that can be measured by certain medical criteria. Participants must have been treated before and are able to attend regular study visits at a participating institution.Inclusion Criteria
My colorectal cancer cannot be removed by surgery and has spread.
You have a quantifiable illness according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Participant Groups
The trial is testing ABBV-400, an experimental drug, in combination with Fluorouracil, Folinic Acid, and Bevacizumab for treating colorectal cancer. It involves different doses of ABBV-400 and compares it to the standard chemotherapy regimen in about 206 patients worldwide over approximately 3 years.
7Treatment groups
Experimental Treatment
Group I: FFB+Irinotecan (Standard of Care [SOC])Experimental Treatment4 Interventions
Participants will receive SOC during the 3 year study duration.
Group II: ABBV-400+Fluorouracil, Folinic Acid, and Bevacizumab (FFB) AExperimental Treatment4 Interventions
Participants will receive escalating ABBV-400 in combination with FFB on dose schedule A as part of the safety lead in, during the 3 year study duration.
Group III: ABBV-400+FFB B LowExperimental Treatment4 Interventions
Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule B as part of the dose optimization , during the 3 year study duration.
Group IV: ABBV-400+FFB B HighExperimental Treatment4 Interventions
Participants will receive ABBV-400 in combination with FFB at the high dose determined in the safety lead in on dose schedule B as part of the dose optimization, during the 3 year study duration.
Group V: ABBV-400+FFB BExperimental Treatment4 Interventions
Participants will receive escalating ABBV-400 in combination with FFB on dose schedule B as part of the safety lead in, during the 3 year study duration.
Group VI: ABBV-400+FFB A LowExperimental Treatment4 Interventions
Participants will receive ABBV-400 in combination with FFB at the low dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
Group VII: ABBV-400+FFB A HighExperimental Treatment4 Interventions
Participants will receive ABBV-400 in combination with FFB at the high dose determined in the safety lead in on dose schedule A as part of the dose optimization, during the 3 year study duration.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Inova Schar Cancer Institute - Fairfax - Innovation Park Drive /ID# 257448Fairfax, VA
MD Anderson Cancer Center /ID# 258713Houston, TX
Yale School of Medicine /ID# 257494New Haven, CT
Comprehensive Cancer Centers of Nevada /ID# 257642Henderson, LA
More Trial Locations
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Who Is Running the Clinical Trial?
AbbVieLead Sponsor
References
Response-independent survival benefit in metastatic colorectal cancer: a comparative analysis of N9741 and AVF2107. [2022]In the phase III study AVF2107g, bevacizumab (BV) demonstrated a survival benefit when added to irinotecan, fluorouracil, and leucovorin (IFL) in first-line metastatic colorectal cancer (mCRC). In a parallel phase III study, Intergroup N9741, oxaliplatin plus fluorouracil and leucovorin (FOLFOX) also demonstrated a survival benefit compared with IFL. As these two superior therapies have differing mechanisms of action, we explored whether the improved survival associated with the superior therapy was dependent on tumor response.
Retrospective analysis on the efficacy of bevacizumab with FOLFOX as a first-line treatment in Japanese patients with metastatic colorectal cancer. [2015]Past reports have suggested that the addition of bevacizumab (BV) to oxaliplatin combined with 5-fluorouracil (5-FU) and folinic acid (leucovorin) (FOLFOX4) provides a limited survival benefit in metastatic colorectal cancer (mCRC). Our study aimed to evaluate the survival benefits of a FOLFOX4 + BV regimen.
Irinotecan, continuous 5-fluorouracil, and low dose of leucovorin (modified FOLFIRI) as first line of therapy in recurrent or metastatic colorectal cancer. [2019]Irinotecan, in combination with 5-fluorouracil (5-FU) and a high dose of leucovorin (LV), known as FOLFIRI regimen, has shown activity in recurrent or metastatic colorectal cancer. Therefore, we evaluated the efficacy and safety of irinotecan, 5-FU and a low dose of LV (modified FOLFIRI) as a first line of therapy for patients with relapsed or metastatic colorectal cancer.
Predictors of the efficacy of FOLFIRI plus bevacizumab as second-line treatment in metastatic colorectal cancer patients. [2021]Fluoropyrimidine-based chemotherapy plus bevacizumab (BV) is the standard treatment for metastatic colorectal cancer (mCRC). The aim of this study was to investigate the efficacy of BV plus FOLFIRI (5-fluorouracil, leucovorin, irinotecan) as second-line treatment in mCRC patients refractory to first-line oxaliplatin-based chemotherapy, and determine potential predictive factors affecting survival.
Dual Inhibition of EGFR and VEGF in Heavily Pretreated Patients with Metastatic Colorectal Cancer. [2018]The aim of this study was to evaluate the efficacy and safety of combining irinotecan, bevacizumab, and cetuximab/panitumumab as a 4th-line treatment in patients with metastatic colorectal cancer.
Bevacizumab in combination with cetuximab and irinotecan after failure of cetuximab and irinotecan in patients with metastatic colorectal cancer. [2018]The efficacy and safety of concurrent administration of irinotecan with the two monoclonal antibodies cetuximab and bevacizumab as fourth line therapy in heavily pretreated patients with metastatic colorectal cancer were evaluated.
Bevacizumab, Irinotecan, and Biweekly Trifluridine/Tipiracil for Metastatic Colorectal Cancer: MODURATE, a Phase Ib Study. [2023]In this phase Ib study MODURATE, we optimized the dosing schedule and tested the efficacy and safety of trifluridine/tipiracil, irinotecan, and bevacizumab in patients with metastatic colorectal cancer with fluoropyrimidine and oxaliplatin treatment failure.
[A clinical experience in treatment with bevacizumab for unresectable colorectal cancer]. [2016]Bevacizumab, a humanized monoclonal antibody to VEGF for advanced recurrent colorectal cancer, has been known for complications of gastrointestinal perforation, hemorrhage, thromboembolism and proteinuria, as adverse effects. These findings must be taken care as well as adverse drug reactions (ADR) caused by combination chemotherapy. We here in present a clinical experience in treatment with bevacizumab for unresectable colorectal cancer. Six patients treated with bevacizumab for over two courses until April 2008 were analyzed for this study. PR was obtained in one case with mFOLFOX6. Even though, grade 3 neutropenia was observed in only one case with FOLFIRI, the other cases had grade 2 or less in ADR. In addition, there were no any specific ADRs related with bevacizumab, so we concluded that combination chemotherapy for advanced recurrent colorectal cancer with bevacizumab was well-tolerated.
The impact of 5-FU-based bolus chemotherapy on survival in patients with advanced colorectal cancer. [2013]An analysis was performed to evaluate whether bolus chemotherapy with 5-fluorouracil (5-FU) and leucovorin (LV) improves survival for patients with advanced colorectal cancer (ACC).