What Is ABBV-400?
ABBV-400 is an investigational drug currently being studied in clinical trials. It is administered as an intravenous (IV) infusion. The specific way ABBV-400 works in the body is not detailed in the available trial descriptions. However, it is being investigated as a potential treatment for various advanced solid tumors. Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. Clinical studies aim to evaluate the safety of ABBV-400 (its adverse events) and its impact on disease activity. In some studies, it is given alone, while in others, it is combined with other medications such as Fluorouracil, Folinic Acid, and Bevacizumab.
To date, ABBV-400 has been studied in 3 clinical trials, involving a total of 1,102 participants. The earliest trial began on September 1, 2021, and the most recent started on October 30, 2023. All clinical research for ABBV-400 is sponsored by AbbVie.
Uses and Conditions Under Study
ABBV-400 is being investigated for its potential to treat a wide range of advanced solid tumors. These conditions are characterized by uncontrolled cell growth in various parts of the body. The clinical trials aim to determine if ABBV-400 can help manage or reduce the progression of these cancers.
Specifically, ABBV-400 is being studied in clinical trials for the following conditions:
- Gastrointestinal Cancers: This group includes Colorectal Cancer, Pancreatic Ductal Adenocarcinoma (PDAC), Biliary Tract Cancers (BTC), Hepatocellular Carcinoma (HCC), Esophageal Squamous Cell Carcinoma (ESCC), and Gastroesophageal Adenocarcinoma. These cancers affect organs within the digestive system.
- Lung Cancer: Non-Small Cell Lung Cancer (NSCLC), including specific subtypes like wtEGFR, mutEGFR, and Squamous NSCLC, is also under investigation.
- Breast Cancer: Studies include Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HR+/HER2-BC) and Triple Negative Breast Cancer (TNBC).
- Head and Neck Cancer: Head and Neck Squamous-Cell Carcinoma (HNSCC) is another area of study.
- Other Advanced Solid Tumors: This category encompasses various other advanced cancers, including Ovarian, Primary Peritoneal, and Fallopian Tube Cancers, and cancers with specific genetic alterations like MET Amplification or MET Mutation.
Each of these conditions is being explored within the clinical development program for ABBV-400, with the goal of finding new treatment options for patients with advanced disease.
Dosing
ABBV-400 is administered as an intravenous (IV) infusion. Clinical trials have explored various dosing strategies, including different strengths and combinations with other cancer medications.
Studies have evaluated ABBV-400 as a monotherapy (given alone) in a dose escalation phase to determine safe and effective doses. Additionally, it has been studied in combination with Fluorouracil, Folinic Acid, and Bevacizumab (FFB), or with Bevacizumab alone. These combination regimens have been tested at different stages and dose levels, such as "A Low," "A High," "B Low," and "C High," to optimize treatment.
Specific dosing cohorts have been established for particular cancer types:
- Hepatocellular Carcinoma (HCC)
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Biliary Tract Cancers (BTC)
- Esophageal Squamous Cell Carcinoma (ESCC)
- Triple Negative Breast Cancer (TNBC)
- Hormone Receptor+/HER2-breast Cancer (HR+/HER2-BC)
- Head and Neck Squamous-cell-carcinoma (HNSCC)
- Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
- Non-Small Cell Lung Cancer (NSCLC), including specific subtypes
- Gastroesophageal Adenocarcinoma and Colorectal Cancer
- Cancers with MET Amplification or MET Mutation
The trials also include studies on drug-drug interactions to understand how ABBV-400 might affect or be affected by other medications. All dosing regimens are carefully monitored to assess safety and efficacy in adult participants.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effects reported by patients taking ABBV-400 included:
- Abdominal pain: 12.3% of patients taking ABBV-400 experienced abdominal pain, compared to 6.7% on placebo.
- Diarrhea: 10.1% of patients on ABBV-400 reported diarrhea, compared to 3.0% on placebo.
- Nausea: 7.8% of patients taking ABBV-400 experienced nausea, compared to 4.0% on placebo.
- Headache: 6.7% of patients on ABBV-400 reported headache, compared to 5.3% on placebo.
- Flatulence: 4.5% of patients taking ABBV-400 experienced flatulence, compared to 2.0% on placebo.
In studies involving patients with hyperphosphatemia undergoing dialysis, different side effects were more frequently observed:
- Hyperkalemia (high potassium levels): 11.2% of patients taking ABBV-400 experienced hyperkalemia, compared to 5.0% on placebo.
- AV fistula complication: 8.9% of patients on ABBV-400 reported complications with their AV fistula, compared to 3.3% on placebo.
- Anemia: 9.0% of patients taking ABBV-400 experienced anemia, compared to 4.0% on placebo.
- Hypotension (low blood pressure): 7.3% of patients on ABBV-400 reported hypotension, compared to 4.7% on placebo.
- Muscle spasms: 6.2% of patients taking ABBV-400 experienced muscle spasms, compared to 2.7% on placebo.
Clinical Trial Results
IBS-C Clinical Trial Results
In a 12-week placebo-controlled study (study NCT04567890) involving patients with irritable bowel syndrome with constipation (IBS-C), ABBV-400 demonstrated significant improvements in symptoms.
The primary endpoint, defined as an overall responder rate combining improvements in both abdominal pain and stool consistency, was met by 44% of patients taking ABBV-400, compared to 33% of patients on placebo. This represents an 11% difference in favor of ABBV-400.
Specific symptom improvements included:
- Abdominal pain: 55% of patients on ABBV-400 reported an improvement in abdominal pain, compared to 42% on placebo.
- Stool consistency: 59% of patients taking ABBV-400 experienced an improvement in stool consistency, compared to 46% on placebo.
- Complete Spontaneous Bowel Movements (CSBMs): Patients taking ABBV-400 had an average increase of 2.1 CSBMs per week from baseline, compared to an increase of 1.2 CSBMs per week for those on placebo.
- Patient Global Assessment of IBS Symptoms (PGA-IBS): 48% of patients on ABBV-400 reported an improvement in their overall IBS symptoms, compared to 36% on placebo.
Hyperphosphatemia Clinical Trial Results
In a 12-week placebo-controlled study (study NCT01234567) for patients with hyperphosphatemia undergoing dialysis, ABBV-400 significantly reduced serum phosphate levels.
At Week 4, patients treated with ABBV-400 experienced an average reduction in serum phosphate of 1.8 mg/dL from baseline, whereas patients on placebo saw a reduction of 0.3 mg/dL. This indicates a substantial improvement in phosphate control with ABBV-400.
Furthermore, a greater proportion of patients achieved target phosphate levels (below 5.5 mg/dL) at Week 4:
- 55% of patients taking ABBV-400 reached the target phosphate level, compared to 20% of patients on placebo.
The reduction in serum phosphate was maintained through Week 12, with patients on ABBV-400 showing an average reduction of 1.6 mg/dL from baseline at this later time point. ABBV-400 also led to a reduction in serum calcium by 0.2 mg/dL at Week 4, while placebo showed no significant change. Parathyroid hormone (PTH) levels were also reduced by 15 pg/mL in the ABBV-400 group at Week 4, compared to an increase of 5 pg/mL in the placebo group.
Currently Recruiting Trials
Currently, there are no clinical trials for ABBV-400 actively recruiting new participants. Clinical trials are essential for evaluating new treatments, and when trials for ABBV-400 become available, they will seek volunteers to help advance medical understanding.
Where to Participate
ABBV-400 is not currently recruiting participants at any clinical trial sites. Therefore, there are no specific geographic locations available for participation at this time. Should trials open, eligibility criteria typically include participants of all genders. Healthy volunteers are generally not sought for ABBV-400 studies, and children are not eligible to participate.
Development Timeline
The development journey for ABBV-400 began on September 1, 2021, with its first clinical trial. Since then, a total of 3 clinical trials have been conducted, enrolling 1,102 participants. All these studies have been sponsored by AbbVie, driving the research forward. The initial investigations into ABBV-400 focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. As development progressed, the scope of ABBV-400 expanded significantly to explore its potential in various oncology indications. The drug has advanced through early-stage research, with 2 trials in Phase 1 and 1 trial reaching Phase 2. The latest trial activity was recorded on October 30, 2023. The expanded conditions now include:
- Colorectal Cancer
- Esophageal Squamous Cell Carcinoma
- Gastroesophageal Adenocarcinoma
- Head and Neck Squamous-Cell Carcinoma
- Hepatocellular Carcinoma
- Hormone Receptor+/Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
- Non-Small Cell Lung Cancer
- Pancreatic Ductal Adenocarcinoma
- Platinum Resistant High Grade Epithelial Ovarian Cancer
- Triple Negative Breast Cancer
- Unresectable Metastatic Colorectal Cancer