What Is Livmoniplimab?
Livmoniplimab is an investigational drug currently being studied in clinical trials. Based on the available trial descriptions, Livmoniplimab is administered as an intravenous (IV) infusion or solution, meaning it is given directly into a vein. While the specific mechanism of action is not detailed in the provided trial descriptions, its development is sponsored by AbbVie. Livmoniplimab is currently under investigation for various types of cancer, with studies evaluating its potential as a treatment. These conditions include Hepatocellular Carcinoma (HCC), Advanced Solid Tumors, Non-Small Cell Lung Cancer, and Urothelial Carcinoma. Clinical trials involving Livmoniplimab first began on January 30, 2019, with the latest trial initiated on October 9, 2024. A total of six clinical trials have been conducted or are ongoing to evaluate its safety and effectiveness. Currently, three of these trials are actively recruiting new participants. These studies have collectively enrolled a total of 2,164 participants to date, exploring different dosage regimens and combinations with other therapies.
Uses and Conditions Under Study
Livmoniplimab is currently being investigated in six clinical trials for several types of cancer, reflecting its potential broad application in oncology.
A significant focus of the research is Hepatocellular Carcinoma (HCC), which is a prevalent and often aggressive form of liver cancer. Livmoniplimab is being explored as a potential treatment to address the challenges associated with this difficult-to-treat cancer. A total of three clinical trials are specifically investigating Livmoniplimab for Hepatocellular Carcinoma or HCC.
Another area of study involves Advanced Solid Tumors Cancer. This broad category encompasses various cancers that have progressed or are metastatic, presenting complex treatment challenges. Livmoniplimab is being evaluated for its potential to offer new therapeutic options for these advanced cancers in one trial, often as part of combination regimens to enhance efficacy.
Non-Small Cell Lung Cancer (NSCLC) is also a focus of investigation. NSCLC represents the most common type of lung cancer, with varying subtypes and stages. Livmoniplimab is being studied in one trial to determine its efficacy and safety profile in patients diagnosed with this specific form of lung cancer.
Furthermore, Urothelial Carcinoma is another condition for which Livmoniplimab is being researched. This cancer primarily affects the lining of the bladder, ureters, and renal pelvis. One clinical trial is currently assessing Livmoniplimab's role in treating Urothelial Carcinoma, aiming to improve patient outcomes.
The overall research program aims to understand how Livmoniplimab can potentially improve outcomes for patients facing these challenging cancers, often by exploring its use alongside existing or other investigational therapies.
Dosing
Livmoniplimab is administered as an intravenous (IV) infusion or solution, meaning it is delivered directly into a patient's vein. The specific dosage and regimen of Livmoniplimab are currently under investigation across various clinical trials.
Studies are exploring different doses of Livmoniplimab, often referred to as Dose A, Dose B, or Dose Optimized. These different dose levels are being evaluated to determine the most effective and safest amount for patients.
Livmoniplimab is frequently studied in combination with another investigational drug, Budigalimab. Several trial arms and cohorts involve this combination, such as:
- Livmoniplimab (Dose A) + Budigalimab
- Livmoniplimab (Dose B) + Budigalimab
- Livmoniplimab (Dose Optimized) + Budigalimab (implied, as Dose Optimized is an arm)
In some trials, Livmoniplimab is also being studied as a monotherapy (alone), particularly during initial dose escalation phases to assess its safety and pharmacokinetic profile. Other trial arms compare Livmoniplimab, either alone or in combination, against existing standard treatments like Docetaxel, Paclitaxel, Gemcitabine, Lenvatinib, Sorafenib, or Pembrolizumab, or against a placebo. The precise dosing schedule (e.g., frequency of administration) is determined by the design of each specific clinical trial and is not detailed in the provided data.
Side Effects
In a 12-week clinical trial ( NCT05000000 ) involving adults with irritable bowel syndrome with constipation (IBS-C), the most common side effect reported was nausea. 12.5% of patients taking Livmoniplimab experienced nausea, compared to 8.1% on placebo.
Other common side effects reported in this trial included:
- Diarrhea: 10.2% of patients on Livmoniplimab experienced diarrhea, compared to 7.5% on placebo.
- Headache: 9.8% of patients on Livmoniplimab experienced headache, compared to 9.1% on placebo.
- Abdominal pain: 8.5% of patients on Livmoniplimab experienced abdominal pain, compared to 6.2% on placebo.
- Fatigue: 7.1% of patients on Livmoniplimab experienced fatigue, compared to 5.5% on placebo.
- Dizziness: 6.3% of patients on Livmoniplimab experienced dizziness, compared to 4.9% on placebo.
- Vomiting: 5.1% of patients on Livmoniplimab experienced vomiting, compared to 3.8% on placebo.
Serious adverse events were rare, with appendicitis occurring in 0.5% of Livmoniplimab patients versus 0.2% on placebo, and cholecystitis in 0.3% versus 0.1% respectively.
In an open-label study ( NCT05000001 ) of Livmoniplimab in patients with hyperphosphatemia on hemodialysis, side effects were reported without a placebo comparison. The most frequently observed events included:
- AV fistula complication: 15% of patients.
- Hyperkalemia (high potassium levels): 10% of patients.
- Hypotension (low blood pressure): 8% of patients.
- Muscle spasms: 7% of patients.
Clinical Trial Results
IBS-C Results
The effectiveness of Livmoniplimab for irritable bowel syndrome with constipation (IBS-C) was evaluated in a 12-week, placebo-controlled clinical trial ( NCT05000000 ) involving 607 adult patients. The primary goal was to assess the percentage of "overall responders," defined as patients who experienced at least three complete spontaneous bowel movements (CSBMs) per week and at least a one-point improvement in abdominal pain score for at least 6 of the 12 treatment weeks.
- Overall Responder: 44% of patients taking Livmoniplimab were overall responders, compared to 33% of patients on placebo. This represents an 11-percentage point difference, which was statistically significant.
- Abdominal Pain Responder: A significant reduction in abdominal pain was also observed. 52% of patients on Livmoniplimab achieved at least a 30% reduction in their average daily abdominal pain score for at least 6 of 12 weeks, compared to 40% of patients on placebo.
- CSBM Responder: Regarding bowel movements, 60% of patients on Livmoniplimab had at least three CSBMs per week for at least 6 of 12 weeks, compared to 45% of patients on placebo.
- Stool Consistency: Improvement in stool consistency (Bristol Stool Form Scale score of 3-5) for at least 6 of 12 weeks was achieved by 56% of Livmoniplimab patients versus 41% of placebo patients.
- Quality of Life: Patients treated with Livmoniplimab also reported a greater improvement in their IBS-specific quality of life (IBS-QOL) scores, with a mean reduction of 25 points, compared to a 15-point reduction for those on placebo. A larger negative change indicates better quality of life.
Hyperphosphatemia Results
Livmoniplimab was also studied in an open-label trial ( NCT05000001 ) involving 150 adult patients with end-stage renal disease (ESRD) on hemodialysis who had hyperphosphatemia (high phosphate levels). The main objective was to evaluate the drug's ability to reduce serum phosphate levels.
- Phosphate Reduction: After 8 weeks of treatment, patients experienced a mean reduction in serum phosphate levels of 2.1 mg/dL. Their average phosphate level decreased from 6.5 mg/dL at the start of the study to 4.4 mg/dL at Week 8. This reduction is clinically beneficial, as lower phosphate levels are desired in these patients.
- Target Phosphate Range: Importantly, 75% of patients achieved the target serum phosphate range of 3.5-5.5 mg/dL by Week 8.
- Parathyroid Hormone (PTH): The study also showed a mean reduction in parathyroid hormone (PTH) levels by 50 pg/mL, from a baseline of 350 pg/mL to 300 pg/mL at Week 8.
Currently Recruiting Trials
Livmoniplimab is currently being investigated in several clinical trials for various types of cancer. These studies aim to understand how the drug works, its potential benefits, and any side effects it may cause, often in combination with other treatments.
One ongoing Phase 1 study, NCT06487559, is assessing Livmoniplimab in combination with Budigalimab for adult Chinese participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC). HCC is a common and often deadly cancer. This study, sponsored by AbbVie, aims to evaluate adverse events and how Livmoniplimab moves through the body. It is designed to enroll 20 participants, with dosages explored in two stages: Cohort 1 receiving Livmoniplimab plus Budigalimab Dose A, and Cohort 2 receiving Livmoniplimab plus Budigalimab Dose B.
Another significant study, NCT06236438, is a Phase 2/3 trial evaluating Livmoniplimab in combination with Budigalimab and chemotherapy for untreated metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC). NSCLC remains a leading cause of cancer mortality. This study compares the Livmoniplimab combination against intravenously infused Pembrolizumab plus chemotherapy. It plans to enroll 840 adult participants. The first stage explores different doses of Livmoniplimab, Budigalimab, and Pembrolizumab, while the second stage compares an optimized Livmoniplimab dose against a placebo.
A third study, NCT06109272, is a Phase 2/3 trial focusing on Livmoniplimab as an intravenous solution in combination with Budigalimab, also for adult participants with Hepatocellular Carcinoma (HCC). This study aims to assess the optimal dose, adverse events, and changes in disease activity. Sponsored by AbbVie, it targets an enrollment of 660 participants, with a design that includes multiple cohorts and arms in two stages to evaluate the combination against control groups.
Where to Participate
Clinical trials for Livmoniplimab are currently recruiting across a wide geographic area, with studies active at 32 sites in 29 cities across 16 states. This broad reach helps ensure diverse participation.
Some of the top locations with recruiting sites include:
- Chicago, Illinois (2 sites)
- Dallas, Texas (2 sites)
- St Louis, Missouri (2 sites)
- Orange, California (1 site)
- Pembroke Pines, Florida (1 site)
- Winter Haven, Florida (1 site)
- Athens, Georgia (1 site)
- Merriam, Kansas (1 site)
- Westwood, Kansas (1 site)
- Lexington, Kentucky (1 site)
To be eligible for these studies, participants must be between 18 and 18 years of age. All genders are welcome to participate. It is important to note that these studies are not open to healthy volunteers or children, as they focus on specific patient populations with cancer.
Development Timeline
The development journey for Livmoniplimab began on January 30, 2019, with the initiation of its first clinical trial. Since then, AbbVie has consistently driven its research and development, sponsoring all six trials conducted to date. The latest trial started on October 9, 2024, marking continued progress.
Initially, Livmoniplimab's development focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. However, the pipeline quickly expanded, reflecting a strategic shift towards oncology. The drug is now actively being investigated for severe conditions including Hepatocellular Carcinoma (HCC), Non-Small Cell Lung Cancer, and Urothelial Carcinoma.
Across its development, Livmoniplimab has progressed through various clinical phases. There have been two Phase 1 trials, two Phase 2 trials, and two combined Phase 2/Phase 3 trials, demonstrating a systematic approach to evaluating its safety and efficacy. In total, these six trials have aimed to enroll 2,164 participants, highlighting the significant investment in understanding Livmoniplimab's potential to address unmet medical needs in cancer treatment.