Study of D3S-002 as Monotherapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations

Phase 1

Active, not recruiting

• Conditions: Advanced Solid Tumors With MAPK Pathway Mutations
• Interventions: Drug: D3S-002

• Registration Number: NCT05886920
• Lead Sponsor: D3 Bio (Wuxi) Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-02
• Study Start: 2023-07-10
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-29
• Primary Completion: 2025-11
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
D3S-002	D3S-002	Dose Escalation, D3S-002 administered orally.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	First dose until 30 days after the last dose (or specified in the protocol)
Number of Participants With Dose-Limiting Toxicities (DLTs)	From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.

Secondary Outcome Measures

Name	Time	Method
D3S-002 half-life (t1/2)	First dose up to 24 months
D3S-002 area under the concentration-time curve (AUC)	First dose up to 24 months
D3S-002 time to maximum plasma concentration (tmax)	First dose up to 24 months
Disease control rate (DCR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)	Until disease progression or end of treatment (up to approximately 24 months)
D3S-002 maximum observed plasma concentration (Cmax)	First dose up to 24 months
Objective response rate (ORR) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)	Until disease progression or end of treatment (up to approximately 24 months)
Progression-free survival (PFS) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)	Until disease progression or end of treatment (up to approximately 24 months)

Trial Locations

Locations (1)

D3 Bio Investigative Site; 🇨🇳 Hangzhou, Zhejiang, China