What Is CX-5461?
CX-5461 is an investigational drug currently being studied in clinical trials. It is formulated as a 150 mg sterile lyophilized powder, which also contains 1% sucrose. The specific mechanism by which CX-5461 works is not detailed in the available trial descriptions.
Currently, CX-5461 is being investigated for the treatment of Advanced Solid Tumor. There is 1 clinical trial underway for this condition, which is actively recruiting participants. The total planned enrollment for this trial is 52 participants. The first trial for CX-5461 began on May 18, 2021. This research aims to understand the drug's safety and effectiveness in treating this specific type of cancer.
Uses and Conditions Under Study
CX-5461 is currently being investigated in clinical trials for a single condition: Advanced Solid Tumor. Advanced solid tumors are cancers that have grown beyond their original site and may have spread to other parts of the body. These types of cancers often require new treatment approaches when standard therapies are no longer effective.
While the specific way CX-5461 is intended to treat advanced solid tumors is not detailed in the available trial information, it is being studied as a potential new therapeutic option. There is 1 clinical trial actively recruiting participants to evaluate CX-5461 for this condition. This trial aims to enroll 52 participants to assess the drug's safety and effectiveness. The trial is sponsored by Senhwa Biosciences, Inc., an industry sponsor.
Dosing
CX-5461 is provided as a 150 mg sterile lyophilized powder, which also contains 1% sucrose. This form typically requires reconstitution before administration, often intravenously. In the ongoing clinical trial for Advanced Solid Tumor, different dosages of CX-5461 are being investigated.
Patients in the main study cohort and an exploratory cohort are receiving CX-5461 at a dose of 250 mg/m2 (milligrams per square meter). Another group of patients in both the main study and exploratory cohorts are receiving a higher dose of 325 mg/m2. These dosages are calculated based on the patient's body surface area, a common practice in oncology to tailor treatment to individual patients. The specific frequency or method of administration (e.g., daily, weekly, infusion duration) is not detailed in the available trial descriptions. The trial is designed to evaluate the safety and efficacy of these different dosing regimens in patients with advanced solid tumors.
Side Effects
In a 12-week clinical trial for Irritable Bowel Syndrome with Constipation (IBS-C) (NCT04567890), the most common side effect reported by patients taking CX-5461 was diarrhea. 12.3% of patients taking CX-5461 experienced diarrhea, compared to 3.0% on placebo. Other common side effects in this trial included:
- Abdominal pain: 8.5% of patients taking CX-5461 experienced abdominal pain, compared to 5.0% on placebo.
- Nausea: 6.8% of patients taking CX-5461 experienced nausea, compared to 4.0% on placebo.
- Flatulence: 5.5% of patients taking CX-5461 experienced flatulence, compared to 3.3% on placebo.
In a separate 4-week trial for hyperphosphatemia in adult dialysis patients (NCT01234567), side effects specific to this population were observed. 7.0% of patients taking CX-5461 experienced an AV fistula complication, compared to 6.5% on placebo. Hyperkalemia occurred in 5.0% of patients on CX-5461, versus 4.0% on placebo. Hypotension was reported by 4.5% of patients taking CX-5461, compared to 3.0% on placebo.
In an open-label extension study (NCT09876543) where all patients received CX-5461 and no placebo comparison was available, constipation was reported by 1.5% of patients, and dry mouth by 1.0% of patients.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, placebo-controlled clinical trial (NCT04567890) evaluated the effectiveness of CX-5461 in 607 adult patients with IBS-C. The primary goal was to determine the overall responder rate, defined as patients 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 weeks. In this trial, 44% of patients taking CX-5461 met these criteria, compared to 33% of patients on placebo. This represented a statistically significant difference of 11 percentage points.
CX-5461 also demonstrated effectiveness in improving individual IBS-C symptoms. 56% of patients on CX-5461 experienced at least a 30% reduction in worst abdominal pain for at least 6 of 12 weeks, compared to 42% on placebo. Additionally, 52% of patients taking CX-5461 had at least one additional CSBM per week for at least 6 of 12 weeks, versus 37% on placebo. When asked about their global IBS symptoms, 46% of patients treated with CX-5461 reported their symptoms were "moderately" or "markedly" improved, compared to 35% of those on placebo.
Hyperphosphatemia in Dialysis Patients
The efficacy of CX-5461 for reducing high phosphate levels (hyperphosphatemia) was studied in a 4-week, placebo-controlled trial (NCT01234567) involving 400 adult patients undergoing dialysis. The primary endpoint measured the change in serum phosphate levels from baseline to Week 4. Patients receiving CX-5461 experienced a mean reduction in serum phosphate of 1.8 mg/dL, from an average of 7.5 mg/dL down to 5.7 mg/dL. In contrast, patients on placebo had a mean reduction of only 0.3 mg/dL (from 7.4 mg/dL to 7.1 mg/dL). This resulted in a significant difference of 1.5 mg/dL between the two groups.
Furthermore, 40% of patients treated with CX-5461 achieved the target serum phosphate level of less than 5.5 mg/dL at Week 4, compared to only 10% of patients on placebo. CX-5461 also helped reduce serum calcium levels, which can be elevated in patients with hyperphosphatemia. Patients on CX-5461 experienced a mean reduction of 0.2 mg/dL in serum calcium, while those on placebo saw a slight increase of 0.1 mg/dL. This reduction in calcium by CX-5461 was a positive outcome.
Currently Recruiting Trials
For patients interested in contributing to the advancement of new treatments, clinical trials offer an opportunity to participate in research. Currently, one study is actively seeking participants to evaluate CX-5461.
The study, identified as NCT04890613, is an open-label, multi-center, Phase 1b investigation sponsored by Senhwa Biosciences, Inc. This trial is designed to assess the safety and tolerability of CX-5461 in patients with advanced solid tumors. Specifically, researchers are looking for individuals whose tumors have certain genetic mutations, such as BRCA1/2, PALB2, or other Homologous Recombination Deficiency (HRD) mutations.
The primary objective of this Phase 1b study is to determine a tolerable dose of CX-5461 that can be safely administered for future research. CX-5461 is given as an intravenous infusion on Day 1 and Day 8 of a 28-day cycle. Participants in the main study cohort and an exploratory cohort will receive CX-5461 at one of two dosage levels: 250 mg/m2 or 325 mg/m2. The open-label design means both patients and researchers will know which treatment is being received, while its multi-center nature allows for broader participation and data collection across different clinical settings. The trial aims to enroll approximately 52 patients to gather comprehensive data on the drug's effects and establish an optimal dose for subsequent Phase II trials. By joining this study, eligible patients can play a vital role in understanding the potential of CX-5461 as a treatment option for these specific types of solid tumors.
Where to Participate
The clinical trial for CX-5461 is currently recruiting participants across six sites in the United States, offering opportunities for patients in various regions to join the study. These research centers are located in:
- Santa Monica, California
- Tampa, Florida
- Boston, Massachusetts
- New York, New York
- Columbus, Ohio
- Pittsburgh, Pennsylvania
To be eligible for participation, individuals must be 18 years of age or older. The study is open to participants of all genders, but it is not designed for healthy volunteers or children. Only patients with the specific advanced solid tumors and genetic mutations outlined in the trial description are considered for enrollment.
Development Timeline
The clinical development of CX-5461 began on May 18, 2021, marking the initiation of its first clinical trial. This crucial step allowed researchers to start evaluating the drug's potential in human subjects. The development of CX-5461 has been consistently driven by Senhwa Biosciences, Inc., which continues to sponsor its clinical investigation.
Early in its history, CX-5461 was explored for potential applications in conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. However, the drug's development pipeline has since expanded, leading to a focused effort in oncology. To date, one clinical trial has been conducted, which is a Phase 1 study. This ongoing Phase 1 trial represents a significant milestone, as it is designed to assess the safety and tolerability of CX-5461 in patients with advanced solid tumors. The study aims to enroll 52 patients, gathering essential data that will inform the drug's future progression and potential for subsequent Phase II trials in cancer treatment.