D3S-003 for KRAS Mutation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called D3S-003, a potential drug for individuals with advanced solid tumors that have a specific genetic mutation known as KRAS p.G12D. The primary goal is to assess the treatment's safety and its effects on the body, while also evaluating its potential effectiveness. Participants will take the drug once or twice daily to determine the optimal dose. Suitable candidates are those whose cancer has not responded to other treatments and have this specific KRAS mutation confirmed by recent tests. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that D3S-003 is likely to be safe for humans?
In this early trial, researchers are testing D3S-003 in humans for the first time. The goal is to determine its safety and how the body processes it. As a Phase 1 trial, the primary focus is on safety. While some information on reactions to D3S-003 may emerge, detailed data on tolerance and potential side effects remain limited.
Since D3S-003 is in the early research stages, information about its safety is still being gathered. Trial participants will help researchers learn more about possible side effects and responses to the treatment.
If D3S-003 receives approval for patient use in the future, it will have undergone further testing to confirm its safety and effectiveness. Currently, the main goal is to ensure its safety in humans.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for KRAS-mutated cancers, which often involve chemotherapy and targeted therapies like EGFR inhibitors, D3S-003 is designed to specifically target the KRAS p.G12D mutation directly. Researchers are excited about D3S-003 because it represents a novel approach by potentially inhibiting a mutation that has been notoriously difficult to target directly. This specificity could mean fewer side effects and more effective treatment for patients with KRAS-mutated solid tumors. Additionally, the treatment's flexible dosing schedule, with both once and twice daily options, may offer more personalized treatment plans for patients.
What evidence suggests that D3S-003 might be an effective treatment for KRAS mutation?
Research has shown that D3S-003 targets a specific change in the KRAS gene, which often plays a role in various cancers. This drug blocks the change, regardless of its activity level. Early laboratory studies demonstrated that D3S-003 can effectively combat tumors and holds promise for further development. By targeting a change significant in many solid tumors, it emerges as a promising treatment option. In this trial, researchers are testing D3S-003 in humans for the first time, with participants receiving either once-daily or twice-daily dosing to assess its effectiveness and safety. Initial results from ongoing studies are encouraging, but further research is necessary to confirm these findings.12567
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors that have a KRAS p.G12D mutation. Participants must have tried standard treatments without success, be in good physical condition (ECOG 0 or 1), and have healthy major organs.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive D3S-003 monotherapy with dose escalation to evaluate safety, tolerability, PK, PD, and preliminary efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- D3S-003
Trial Overview
The study is testing D3S-003, a new drug given alone to people with advanced cancers carrying the KRAS p.G12D mutation. The main goal is to find a safe dose and see how the body handles the drug.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Part 1a Dose Escalation in subjects with KRAS p.G12D-mutated solid tumors (Once Daily Dosing) Part 1b Dose Escalation in subjects with KRAS p.G12D-mutated solid tumors (Twice Daily Dosing)
Find a Clinic Near You
Who Is Running the Clinical Trial?
D3 Bio (Wuxi) Co., Ltd
Lead Sponsor
Citations
D3S-003: Uses, Side Effects, Dosing & 1 Clinical Trials
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 ...
KRAS Mutations in Solid Tumors: Characteristics, Current ...
Studies from the TCGA database suggest that the prevalence of KRAS mutations in PDAC is the highest (over 80%) of all gene mutations, with G12D being the most ...
NCT05410145 | A Study of D3S-001 Monotherapy or ...
Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood. Subject must have measurable ...
D3 Bio Receives U.S. FDA Clearance for Two IND ...
D3S‑003 is an orally bioavailable, allele‑specific KRAS G12D inhibitor that targets both the GDP‑bound (OFF) and GTP‑bound (ON) conformations.
D3S-003 for KRAS Mutation
This Phase 1 medical study run by D3 Bio (Wuxi) Co., Ltd is evaluating whether D3S-003 will have tolerable side effects & efficacy for ...
Targeting KRAS - PMC - NIH
Notably, anti-tumor responses were observed in tumors with G12D, G12V and G12R mutations and several prior lines of therapy (median of 3 prior ...
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ctv.veeva.com
ctv.veeva.com/study/a-phase-1-study-of-d3s-003-as-monotherapy-in-participants-with-advanced-solid-tumors-with-a-kras-pgA Phase 1 Study of D3S-003 as Monotherapy in Participants ...
This is a first-in-human (FIH) multicenter, open-label, dose-escalation Phase 1 clinical trial to evaluate safety, tolerability, ...
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