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NCT05886920 · ClinicalTrials.gov registry record · Phase 1

A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations

A Phase 1 study of Advanced Solid Tumors With MAPK Pathway Mutations, sponsored by D3 Bio (Wuxi) Co..

Active
Registry status
Phase 1
Development phase
67
Enrollment target
10
Study locations

NCT05886920: Active Phase 1 study of Advanced Solid Tumors With MAPK Pathway Mutations, sponsored by D3 Bio (Wuxi) Co..

NCT05886920 is a Phase 1 study of Advanced Solid Tumors With MAPK Pathway Mutations that is active but no longer recruiting, run by D3 Bio (Wuxi) Co.. The registered enrollment target is 67 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05886920, a Phase 1 study of Advanced Solid Tumors With MAPK Pathway Mutations, is active but no longer recruiting, sponsored by D3 Bio (Wuxi) Co..

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
67 participants
Enrollment target
10
Study locations

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.

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

FieldValue
Enrollment Target 67 participants
Start Date 2023-07-10
Est. Completion 2028-04
Phase Phase 1
D3 Bio (Wuxi) Co.

4 total trials

What the registry record for NCT05886920 still lists

NCT05886920 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).

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.

NCT05886920 lists 10 locations in 10 states (Michigan, New York, New South Wales).

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.

What interventions are being tested in trial NCT05886920?

The interventions under investigation include: D3S-001 (DRUG), D3S-002 (DRUG).

Who is sponsoring clinical trial NCT05886920?

This trial is sponsored by D3 Bio (Wuxi) Co., which has 4 total clinical trials registered on ClinicalTrials.gov.

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.

How this trial's enrollment target compares

Where NCT05886920's enrollment target sits among peer trials

67 782nd of 2000 higher than 1,215 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05886920, the US trial registry maintained by the National Library of Medicine. NCT05886920 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.