NCT05886920

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 1/2, Open Label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Recommended Phase 2 Dose of D3S-002 Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: D3 Bio (Wuxi) Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Advanced Solid Tumors With MAPK Pathway Mutations

Interventions

Type	Name	Description
DRUG	D3S-002	Oral Tablet
DRUG	D3S-001	Oral Capsule

Timeline

• Start date: 2023-07-10
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2023-06-02
• Last updated: 2026-03-23

Locations

10 sites across 3 countries: United States, Australia, China

Regulatory

• FDA-regulated drug study