Clinical Trial

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

Recruiting Phase 1/2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 changes
critical Trial status changed: Active, Not Recruiting → Recruiting 2026-06-09
notable Primary completion pushed: 2028-04 -> 2028-08 2026-06-09
minor Completion pushed: 2028-04 -> 2028-08 2026-06-09
notable Trial sites expanded: 10 -> 14 locations 2026-05-30
Trial Details
NCT Number NCT05886920
Lead Sponsor D3 Bio (Wuxi) Co., Ltd
Conditions Advanced Solid Tumors With MAPK Pathway Mutations
Enrollment 67 participants
Start Date 2023-07-10
Primary Completion 2028-08 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-08-06