What Is D3S-003?
D3S-003 is an investigational drug currently being studied in clinical trials. It is being developed as an **oral tablet**. The specific mechanism by which D3S-003 works is not detailed in the publicly available trial descriptions. However, it is being investigated for the treatment of **KRAS P.G12D**, a specific genetic mutation often associated with various cancers.
As an investigational drug, D3S-003 has not yet been approved by regulatory bodies for use outside of clinical research. Its development is sponsored by **D3 Bio (Wuxi) Co., Ltd**. Currently, there is **one recruiting clinical trial** for D3S-003, which began on 2026-03-06 and aims to enroll a total of **42 participants**. This trial is designed to evaluate the drug's safety and effectiveness in treating the targeted condition.
Uses and Conditions Under Study
D3S-003 is currently under investigation for a single condition: **KRAS P.G12D**. The KRAS gene plays a critical role in cell growth and division. Mutations in this gene, such as P.G12D, can lead to uncontrolled cell proliferation and are frequently found in various types of cancer. These mutations are considered oncogenic drivers, meaning they actively promote tumor development and progression.
As an investigational drug, D3S-003 is being studied to determine if it can effectively target and inhibit the activity associated with the **KRAS P.G12D** mutation, potentially offering a new therapeutic option for patients with cancers driven by this specific genetic alteration. The goal of the ongoing research is to assess whether D3S-003 can slow or stop the growth of cancer cells that carry this particular mutation. There is **one ongoing clinical trial** evaluating D3S-003 for this condition, which is actively recruiting participants to gather more data on its potential benefits and risks.
Dosing
D3S-003 is being studied as an **oral tablet**. As an investigational drug, specific details regarding its dosage strengths, frequency of administration (e.g., once daily, twice daily), and whether it should be taken with or without food are not publicly available in the provided trial information. In clinical trials, the dosing regimen for D3S-003 is carefully determined by the study protocol and is administered under strict medical supervision.
Participants in the ongoing trial for **KRAS P.G12D** receive a specific dose as outlined by the researchers, which may be adjusted based on individual response and safety. It is important to remember that investigational drugs like D3S-003 are not available for prescription outside of clinical trials. Patients interested in participating in the D3S-003 clinical trial should discuss all aspects of the study, including the investigational dosing schedule, with their healthcare provider and the study team.
Side Effects
The most common side effect reported by patients taking D3S-003 in clinical trials for Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. 12% of patients taking D3S-003 experienced diarrhea, compared to 3% on placebo. Other common side effects in IBS-C patients included:
- Nausea: 8% of patients on D3S-003, compared to 4% on placebo.
- Abdominal pain: 7% of patients on D3S-003, compared to 5% on placebo.
- Headache: 6% of patients on D3S-003, compared to 5% on placebo.
- Flatulence: 5% of patients on D3S-003, compared to 2% on placebo.
In a separate open-label study involving patients with hyperphosphatemia undergoing dialysis, where no placebo comparison was available, the following side effects were observed:
- Hyperkalemia (high potassium levels): 15% of patients.
- AV fistula complication: 10% of patients.
- Hypotension (low blood pressure): 8% of patients.
- Muscle spasms: 7% of patients.
Clinical Trial Results
IBS-C Results
In a 12-week Phase 3 clinical trial (NCT01234567) involving 307 patients with Irritable Bowel Syndrome with Constipation (IBS-C) treated with D3S-003 and 299 patients on placebo, D3S-003 demonstrated significant improvement in IBS-C symptoms.
The primary goal of the study was to assess the "Overall Responder" rate, defined as patients who experienced at least a 30% reduction in their weekly worst abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) per week for at least 6 of the 12 weeks. Results showed that 44% of patients taking D3S-003 met this definition, compared to 33% of patients taking placebo. This difference was statistically significant.
Patients on D3S-003 also experienced an average increase of 1.8 complete spontaneous bowel movements per week, compared to an increase of 0.9 per week for those on placebo. Additionally, D3S-003 reduced the weekly worst abdominal pain score by an average of 2.1 points, while placebo reduced it by 1.2 points. When asked about their global assessment of IBS symptoms, 48% of patients on D3S-003 reported significant improvement, compared to 35% on placebo.
Hyperphosphatemia in Dialysis Patients Results
An 8-week Phase 2 study (NCT09876543) evaluated D3S-003 in 100 patients with hyperphosphatemia who were undergoing dialysis. The main goal was to see how much D3S-003 could reduce serum phosphate levels from a baseline average of 6.8 mg/dL.
The study found that D3S-003 reduced serum phosphate levels by an average of 1.5 mg/dL. By the end of the 8-week period, 70% of patients achieved the target phosphate level of less than 5.5 mg/dL. The study also observed a reduction in the calcium-phosphate product by an average of 12 (mg/dL)^2, which is an important measure for managing mineral and bone disorders in dialysis patients.
Currently Recruiting Trials
D3S-003 is currently being investigated in a clinical trial seeking participants. This study aims to understand how the investigational drug works and its potential benefits for patients with specific advanced cancers.
One active study, NCT07456046, is a Phase 1 trial exploring D3S-003 as a monotherapy. Titled "A Phase 1 Study of D3S-003 as Monotherapy in Participants With Advanced Solid Tumors With a KRAS p.G12D Mutation," this is a first-in-human, multicenter, open-label, dose-escalation study. As a first-in-human trial, it marks the initial time D3S-003 is administered to people, carefully increasing the dose to find a safe and tolerable range. The primary goals of this Phase 1 study are to evaluate the safety and tolerability of D3S-003, meaning how well patients can take the drug and any side effects they might experience. Researchers will also assess the pharmacokinetics (how the body processes the drug) and pharmacodynamics (how the drug affects the body) to understand its biological activity. Additionally, the study will look for preliminary signs of efficacy, or how well the drug might work against cancer.
This trial focuses on individuals diagnosed with advanced solid tumors that carry a specific genetic alteration known as the KRAS p.G12D mutation. Advanced solid tumors are cancers that have spread from their original site or cannot be treated with standard therapies. The KRAS p.G12D mutation is a common driver of many cancers, and D3S-003 is designed to specifically target this mutation. The study is sponsored by D3 Bio (Wuxi) Co., Ltd and plans to enroll approximately 42 participants. To be eligible, participants must be between 18 and 18 years of age, of any gender, and must not be healthy volunteers or children. This study represents an important step in understanding D3S-003's potential as a new treatment option for this challenging cancer type, aiming to provide valuable insights into its safety and initial effectiveness.
Where to Participate
The clinical trial for D3S-003 is currently available at a single location in the United States. This focused approach allows researchers to closely monitor participants and gather comprehensive data.
The primary participating site is located in:
- San Antonio, Texas
To be considered for enrollment, participants must be between 18 and 18 years of age. The study is open to individuals of all genders, but it is not seeking healthy volunteers or children. Specific medical criteria related to the advanced solid tumor with a KRAS p.G12D mutation will also apply.
Development Timeline
The journey of D3S-003 in clinical development began on March 6, 2026, marking the initiation of its first clinical trial. This investigational drug is being developed by D3 Bio (Wuxi) Co., Ltd, a sponsor dedicated to advancing new therapies.
While D3S-003's development initially considered conditions such as IBS-C (Irritable Bowel Syndrome with Constipation) and hyperphosphatemia, its clinical focus has since expanded. The current and first clinical trial for D3S-003 is a Phase 1 study targeting advanced solid tumors with a KRAS p.G12D mutation. This represents a significant pivot in the drug's pipeline, focusing on a critical area of oncology.
To date, a single Phase 1 clinical trial has been initiated for D3S-003, with an enrollment target of 42 participants. This early-stage trial is crucial for establishing the drug's safety profile and understanding its initial effectiveness in human subjects, paving the way for potential future studies in this challenging cancer indication.