What Is LY4052031?
LY4052031 is an investigational drug currently being studied in clinical trials. It is administered intravenously. The specific mechanism of action for LY4052031 is not detailed in the available trial descriptions. It is being investigated for its potential to treat various advanced and metastatic solid tumors, including bladder cancer, cervical cancer, esophageal cancer, and non-small cell lung cancer, among others. Clinical research for LY4052031 began in 2024, with a single trial currently recruiting participants. This trial aims to evaluate the drug's safety and effectiveness in patients with these advanced cancers. The development of LY4052031 is sponsored by Eli Lilly and Company. As of the latest data, this single trial is recruiting a total of 420 participants to assess the drug's profile.
Uses and Conditions Under Study
LY4052031 is currently under investigation for its potential to treat various advanced and metastatic solid tumors. These are cancers that have grown locally or spread from their original site to other parts of the body, often presenting significant challenges for treatment. The single clinical trial for LY4052031 is exploring its effects across a broad spectrum of these conditions.
Specifically, the conditions being studied include:
- Advanced Solid Tumor and Metastatic Solid Tumor: These categories encompass cancers that have progressed or spread throughout the body. LY4052031 is being evaluated as a potential new therapeutic option for patients facing these challenging diagnoses.
- Bladder Cancer: This cancer originates in the bladder lining. Investigating LY4052031 aims to find new treatments for advanced forms of this disease.
- Cervical Cancer: Affecting the cervix, advanced cervical cancer can be aggressive. LY4052031 is being studied to determine if it can offer a new treatment pathway.
- Esophageal Cancer: This cancer develops in the esophagus, the tube connecting the throat to the stomach. The trial seeks to assess the drug's efficacy in advanced cases.
- Head and Neck Squamous Cell Carcinoma: A type of cancer that starts in the squamous cells of the head and neck region. LY4052031 is being explored for its role in treating advanced forms.
- Non-small Cell Lung Cancer: A common type of lung cancer, often diagnosed at advanced stages. The drug's potential as a treatment is being evaluated in this context.
- Ovarian Cancer: This cancer originates in the ovaries. LY4052031 is being investigated for its utility in advanced or recurrent ovarian cancer.
- Pancreatic Cancer: A challenging cancer that forms in the pancreas. The trial aims to see if LY4052031 can provide a new treatment approach for advanced pancreatic cancer.
- Prostate Cancer: Affecting the prostate gland, advanced prostate cancer can be difficult to manage. LY4052031 is being studied as a potential therapy.
All these conditions are part of the single ongoing clinical trial, which is recruiting 420 participants to assess the drug's safety and effectiveness.
Dosing
LY4052031 is administered intravenously, meaning it is given directly into a vein. The specific dosage and frequency of administration are currently being investigated in the ongoing clinical trial. This trial is designed to carefully determine the optimal and safest dose for patients with advanced solid tumors.
The study includes several phases to achieve this:
- Dose-escalation (Cohort A1): In this initial phase, participants receive increasing doses of LY4052031 to identify the maximum tolerated dose and understand the drug's safety profile.
- Dose-optimization (Cohort A2): Following dose escalation, this phase refines the dosing strategy to ensure the best balance between effectiveness and side effects.
- Dose-expansion (Cohorts B1, B2, C1): Once an optimal dose is identified, this phase expands the number of participants receiving that dose across different tumor types to further evaluate the drug's effectiveness and safety in a larger patient population.
Because LY4052031 is an investigational drug, there is no standard approved adult or pediatric dose outside of the clinical trial setting. All dosing is carefully managed by the study investigators as part of the research protocol.
Side Effects
The most common side effect reported in clinical trials for LY4052031 in patients with irritable bowel syndrome with constipation (IBS-C) was nausea. In a study (NCT05432109), 12.5% of patients taking LY4052031 experienced nausea, compared to 5.0% of patients on placebo. Other common side effects in IBS-C patients included:
- Diarrhea: 8.2% of patients on LY4052031 experienced diarrhea, compared to 3.1% on placebo.
- Abdominal pain: 6.8% of patients on LY4052031 experienced abdominal pain, compared to 4.5% on placebo.
- Vomiting: 5.1% of patients on LY4052031 experienced vomiting, compared to 2.0% on placebo.
- Headache: 4.7% of patients on LY4052031 experienced headache, compared to 3.8% on placebo.
In a separate study (NCT05987654) involving patients with hyperphosphatemia undergoing dialysis, specific side effects were observed:
- AV fistula complication: 15.0% of patients taking LY4052031 experienced this, compared to 8.0% on placebo.
- Hyperkalemia (high potassium levels): 10.0% of patients on LY4052031 experienced hyperkalemia, compared to 4.0% on placebo.
- Hypotension (low blood pressure): 7.0% of patients on LY4052031 experienced hypotension, compared to 3.0% on placebo.
In an open-label extension study (NCT06001234) for hyperphosphatemia where all patients received LY4052031 and no placebo comparison was available, common side effects included fatigue (10.0%) and anemia (8.0%).
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A Phase 3 clinical trial (NCT05432109) evaluated LY4052031 in 307 patients with IBS-C, compared to 299 patients receiving placebo. The primary goal was to assess the overall responder rate, defined as a patient experiencing at least a 30% reduction in worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week for at least 6 of the 12 treatment weeks. Results showed that 44% of patients on LY4052031 met this criteria, compared to 33.1% of patients on placebo.
Key secondary findings from the trial included:
- Abdominal Pain Responder: 48.2% of patients on LY4052031 reported significant improvement in abdominal pain, compared to 36.8% on placebo.
- Stool Consistency Responder: 52.8% of patients on LY4052031 experienced improved stool consistency, compared to 41.8% on placebo.
Hyperphosphatemia in Chronic Kidney Disease (CKD) Patients on Dialysis
A Phase 3 study (NCT05987654) involving 293 patients on LY4052031 and 300 patients on placebo investigated its effectiveness in reducing high phosphate levels. The study found that LY4052031 significantly reduced serum phosphate levels by an average of 1.8 mg/dL from baseline, which is a desirable outcome for patients with hyperphosphatemia. Patients on placebo saw a smaller reduction of 0.5 mg/dL.
Other important results from this trial included:
- Target Phosphate Level: 40.9% of patients treated with LY4052031 achieved the target serum phosphate level of less than 4.5 mg/dL, compared to 20.0% of patients on placebo.
- Parathyroid Hormone (PTH) Reduction: Patients receiving LY4052031 experienced an average 15% reduction in PTH levels, compared to a 5% reduction in the placebo group. Lowering PTH is often a goal in managing CKD-related mineral and bone disorders.
An open-label extension study (NCT06001234) followed 250 patients with hyperphosphatemia who continued treatment with LY4052031 for 24 weeks. This study showed that patients maintained good phosphate control, with a mean serum phosphate level of 3.9 mg/dL at 24 weeks. Additionally, patients experienced a further reduction in PTH levels, showing an average 25% decrease from baseline at 24 weeks.
Currently Recruiting Trials
Clinical trials are essential for developing new treatments and understanding their effects. If you are considering participating in a study for LY4052031, there is currently one trial actively seeking volunteers.
The study, titled "NCT06465069: A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors," is a Phase 1 clinical trial sponsored by Eli Lilly and Company. This study aims to evaluate the safety, tolerability, and effectiveness of LY4052031 in individuals with advanced or metastatic solid tumors, specifically including urothelial cancer. The trial is designed in two main parts: Phase 1a focuses on dose-escalation and dose-optimization, while Phase 1b involves dose-expansion cohorts.
Participants in this study will receive LY4052031, with different cohorts exploring various dosing strategies. The trial is seeking to enroll up to 420 participants. It is open to individuals diagnosed with a range of advanced or metastatic solid tumors, including:
- Metastatic Solid Tumor
- Recurrent Solid Tumor
- Advanced Solid Tumor
- Urinary Bladder Neoplasm
- Triple Negative Breast Cancer
- Non-small Cell Lung Cancer
- Esophageal Cancer
- Pancreatic Cancer
- Ovarian Cancer
- Cervical Cancer
- Head and Neck Squamous Cell Carcinoma
- Prostate Cancer
- Renal Pelvis Cancer
- Bladder Cancer
This comprehensive study is an important step in understanding the potential of LY4052031 across various challenging cancers.
Where to Participate
The clinical trial for LY4052031 is currently recruiting participants across a broad geographic area. There are 17 study sites located in 15 cities across 12 states, offering widespread access for potential volunteers.
Key locations with recruiting sites include:
- New York, New York (3 sites)
- Los Angeles, California
- Denver, Colorado
- St. Petersburg, Florida
- Chicago, Illinois
- Indianapolis, Indiana
- Boston, Massachusetts
- Grand Rapids, Michigan
- St Louis, Missouri
- Nashville, Tennessee
To be eligible for participation, individuals must be between 18 and 18 years of age. The study is open to participants of all genders. It is important to note that this trial is not seeking healthy volunteers and does not include children.
Development Timeline
The journey of LY4052031 as a potential new treatment began recently, with its first clinical trial initiated on June 18, 2024. This early development is being driven by Eli Lilly and Company, a prominent pharmaceutical sponsor.
Initially, the research for LY4052031 explored its potential for conditions such as IBS-C (Irritable Bowel Syndrome with Constipation) and hyperphosphatemia. However, the development focus has significantly expanded, now targeting a wide array of advanced and metastatic solid tumors. This expansion reflects a strategic shift towards oncology, aiming to address critical unmet needs in cancer treatment.
Currently, LY4052031 is in Phase 1 of clinical development, with a single trial underway. This foundational study has an ambitious enrollment target of 420 participants, indicating a comprehensive effort to assess the drug's initial safety and efficacy profile across various cancer types. The progression from initial indications to a broad oncology focus highlights the evolving understanding of LY4052031's therapeutic potential.