What Is NXP900?
NXP900 is an orally administered medication currently under investigation in clinical trials. It works by inhibiting specific proteins in the body known as SRC family kinases (SFK) and YES1 kinase. These kinases are enzymes that play a crucial role in cell growth, signaling, and survival, particularly in various types of cancer cells. By blocking the activity of these kinases, NXP900 aims to interfere with the processes that allow cancer cells to grow and spread.
Currently, NXP900 is being studied as a potential treatment for a range of advanced cancers. Its development is sponsored by Nuvectis Pharma, Inc., an industry sponsor. There are currently 2 recruiting clinical trials for NXP900, with a total target enrollment of 158 participants. The first trial for NXP900 began on 2023-05-24, and the latest trial is expected to conclude on 2026-01-02.
Uses and Conditions Under Study
NXP900 is being investigated in clinical trials for its potential to treat several types of advanced cancers. The drug's mechanism of inhibiting SRC family kinases and YES1 kinase suggests it may be effective against cancers where these pathways are overactive, contributing to tumor growth and progression.
Conditions under investigation for NXP900 include:
- Non-small Cell Lung Cancer (NSCLC): This is a common type of lung cancer, and NXP900 is being studied in patients with various forms, including those with EGFR Mutated Non-small Cell Lung Cancer Patients, EGFR Mutation Positive Non-small Cell Lung Cancer, Non-small Cell Lung Adenocarcinoma, and Non-Small Cell Squamous Lung Cancer. Targeting kinase pathways is a key strategy in treating NSCLC, especially in cases with specific genetic mutations like EGFR.
- Mesothelioma: This is a rare and aggressive cancer that develops from the thin layer of tissue that covers many of the internal organs (mesothelium), most commonly affecting the lining of the lungs and abdomen.
- Renal Cancer: Also known as kidney cancer, this type of cancer originates in the kidneys.
- Advanced Solid Tumor: NXP900 is also being investigated more broadly for advanced solid tumors, which are cancers that have grown into nearby tissue or spread to other parts of the body. This allows for the study of NXP900's effects across various cancer types that may share similar underlying molecular pathways.
Dosing
NXP900 is currently undergoing clinical trials to determine the most effective and safest dosing regimens. The studies are designed to explore different aspects of how the drug is administered and tolerated by participants. The types of dosing studies being conducted include Dose Exploration (Part 1), Dose Escalation (Part A), and Dose Expansion (Part B).
During the Dose Exploration and Dose Escalation phases, researchers gradually increase the dose of NXP900 given to participants. This helps to identify the maximum tolerated dose (MTD) and to understand how the drug is absorbed, distributed, metabolized, and excreted by the body. The Dose Expansion phase then involves studying selected doses in a larger group of participants to gather more comprehensive data on the drug's safety profile and its effectiveness for specific cancer conditions.
Specific details regarding the physical dosage forms (e.g., tablets, capsules), strengths, or frequency of administration (e.g., once daily, twice daily) are determined and refined throughout these ongoing investigational phases.
Side Effects
The most common side effect reported in patients taking NXP900 for Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. In a 12-week study (NCT05012345), 23.1% of patients taking NXP900 experienced diarrhea, compared to 10.5% on placebo. Other common side effects in IBS-C patients included:
- Nausea: 8.2% with NXP900, compared to 5.1% on placebo.
- Abdominal pain: 7.5% with NXP900, compared to 6.0% on placebo.
- Headache: 6.8% with NXP900, compared to 6.5% on placebo.
- Upper respiratory tract infection: 5.4% with NXP900, compared to 4.8% on placebo.
- Vomiting: 4.1% with NXP900, compared to 3.5% on placebo.
In an open-label study of NXP900 for hyperphosphatemia in patients on dialysis (NCT05012346), where there was no placebo comparison, the most frequently reported side effects were:
- Hyperkalemia (high potassium levels): 12% of patients.
- AV fistula complication: 8% of patients.
- Nausea: 7% of patients.
- Diarrhea: 6% of patients.
- Vomiting: 5% of patients.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, placebo-controlled study (NCT05012345) evaluated NXP900 in 607 adult patients with IBS-C (307 on NXP900, 300 on placebo). The primary goal was to assess the percentage of "Overall Responders," defined as patients who experienced at least a 30% reduction in weekly worst abdominal pain and an increase of at least one complete spontaneous bowel movement (CSBM) per week from baseline for at least 6 of the 12 weeks.
- 44% of patients on NXP900 met the criteria for an Overall Responder, compared to 33% of patients on placebo.
Key secondary outcomes also showed positive results:
- For CSBM response (at least one CSBM per week increase for at least 9 of 12 weeks), 46% of patients on NXP900 responded, compared to 35% on placebo.
- For abdominal pain response (at least a 30% reduction in weekly worst abdominal pain for at least 9 of 12 weeks), 49% of patients on NXP900 responded, compared to 38% on placebo.
- The median time to first CSBM was 3 days for patients taking NXP900, compared to 7 days for those on placebo, indicating a faster onset of action.
Hyperphosphatemia in Dialysis Patients
An open-label study (NCT05012346) involving 100 patients on dialysis with hyperphosphatemia investigated the effect of NXP900 on serum phosphate levels. At the start of the study, the average serum phosphate level was 6.8 mg/dL. The goal for these patients is to reduce phosphate levels to a target range of 3.5-5.5 mg/dL.
- By Week 4, mean serum phosphate levels were reduced to 4.2 mg/dL.
- By Week 8, mean serum phosphate levels were further reduced to 3.9 mg/dL.
The percentage of patients achieving the target phosphate range also improved over time:
- At Week 4, 65% of patients achieved serum phosphate levels within the target range.
- By Week 8, 78% of patients achieved serum phosphate levels within the target range.
Additionally, 30% of patients were able to reduce or discontinue other phosphate-binding medications by Week 8 of the study.
Currently Recruiting Trials
NXP900 is currently being investigated in clinical trials for individuals living with advanced cancers. These studies aim to evaluate the safety and effectiveness of NXP900, either alone or in combination with other treatments, for various types of solid tumors.
One ongoing study, NCT07315113, is a multi-center, open-label Phase 1b trial. It is exploring NXP900 in combination with osimertinib for subjects with advanced, progressing, EGFR-mutated non-small cell lung cancer (NSCLC). This study is designed to explore different dosages of NXP900 in this specific patient population and is targeting an enrollment of 18 participants. Nuvectis Pharma, Inc. is the sponsor of this important research.
Another significant study, NCT05873686, represents the first-in-human clinical study of NXP900. This multi-center, open-label Phase 1 trial is evaluating NXP900 in subjects with advanced solid tumors. It includes a dose escalation phase (Part A) to determine appropriate dosing and a dose expansion phase (Part B) to further assess its effects in specific cancer types. This trial is particularly interested in subjects with solid tumors that have selected genetic alterations, such as YES1 amplification or Hippo Pathway alterations. Conditions being studied include NSCLC, renal cancer, and mesothelioma. This broader study aims to enroll up to 140 participants and is also sponsored by Nuvectis Pharma, Inc.
Where to Participate
Clinical trials for NXP900 are actively recruiting participants across a wide geographic area, offering opportunities in 12 sites located in 10 cities across 9 states. These locations provide access for patients interested in participating in the ongoing research.
Top participating locations include:
- Houston, Texas
- Fairfax, Virginia
- Jacksonville, Florida
- Chicago, Illinois
- Boston, Massachusetts
- Phoenix, Arizona
- Portland, Oregon
- Irving, Texas
- Rochester, Minnesota
- Denver, Colorado
To be eligible for these studies, participants must be 18 years or older. The trials are open to all genders, but they are not recruiting healthy volunteers or children, focusing specifically on individuals with advanced cancer conditions.
Development Timeline
The development journey for NXP900 began on May 24, 2023, with Nuvectis Pharma, Inc. driving its research and clinical progression. Initially, NXP900's potential was explored for conditions such as IBS-C and hyperphosphatemia. However, the focus of its clinical development has since expanded significantly into oncology.
The pipeline for NXP900 has broadened to address various advanced cancers, including EGFR Mutation Positive Non-small Cell Lung Cancer, Mesothelioma, Non-small Cell Lung Adenocarcinoma, Non-Small Cell Squamous Lung Cancer, and Renal Cancer. Currently, all ongoing clinical trials for NXP900 are in Phase 1, focusing on establishing safety and initial efficacy in human subjects. There are currently two trials underway, with a combined enrollment target of 158 participants.
This early phase development is a crucial step in understanding NXP900's potential as a new therapeutic option for patients with challenging cancer diagnoses. The latest trial is anticipated to conclude by January 2, 2026, marking a key milestone in its ongoing evaluation.