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A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations
NCT05886920 · View on ClinicalTrials.gov ↗
Study Summary
This first-in-human (FIH) study aims to assess the safety, tolerability, pharmacokinetics, and recommended phase 2 dose (RP2D) of D3S-002 given orally daily for 21-day cycles in adult subjects with advanced solid tumors with mitogen-activated protein kinase (MAPK) pathway mutations.
Conditions Studied
Interventions
- DRUG D3S-001
- DRUG D3S-002
Study Locations (10)
Michigan
- D3 Bio Investigative Site — Detroit
New York
- D3 Bio Investigative Site — New York
New South Wales
- D3 Bio Investigative Site — Blacktown
South Australia
- D3 Bio Investigative Site — Bedford Park
Western Australia
- D3 Bio Investigative Site — Nedlands
Beijing Municipality
- D3 Bio Investigative Site — Beijing
Guangdong
- D3 Bio Investigative Site — Guangzhou
Heilong Jiang
- D3 Bio Investigative Site — Harbin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2023-07-10 |
| Est. Completion | 2028-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05886920
The ClinicalTrials.gov registry entry for NCT05886920 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is D3 Bio (Wuxi) Co., which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Advanced Solid Tumors With MAPK Pathway Mutations appearing as the primary indexed condition, and to 2 interventions — of which D3S-001 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05886920 reports 10 study locations spanning 10 distinct geographic areas — top geographies include Michigan, New York, New South Wales. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05886920 about?
NCT05886920 is a clinical study titled "A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations". This first-in-human (FIH) study aims to assess the safety, tolerability, pharmacokinetics, and recommended phase 2 dose (RP2D) of D3S-002 given orally daily for 21-day cycles in adult subjects with advanced solid tumors with mitogen-activated protein kinase (MAPK) pathway mutations.
What is the current status of trial NCT05886920?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2023-07-10. Estimated completion is 2028-04.
What conditions does trial NCT05886920 study?
This clinical trial studies the following conditions: Advanced Solid Tumors With MAPK Pathway Mutations. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05886920?
The interventions under investigation include: D3S-001 (DRUG), D3S-002 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05886920?
This trial is sponsored by D3 Bio (Wuxi) Co., which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05886920 being conducted?
This trial has 10 study locations across Michigan, New York, New South Wales, South Australia, Western Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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