NCT05410145

A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

A Phase 1/2, Open Label, Dose-escalation, and Dose-expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 442 (estimated)
• Sponsor: D3 Bio (Wuxi) Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human (FIH), multicenter, open-label, dose-escalation, and dose-expansion Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of D3S-001 or combination therapy in subjects with advanced KRAS p.G12C mutant solid tumors. D3S-001 will be taken daily by oral administration in 21-day treatment cycles.

Conditions

• KRAS P.G12C

Interventions

Type	Name	Description
DRUG	D3S-001	Oral
DRUG	Pembrolizumab	Intravenous
DRUG	Cisplatin	Intravenous
DRUG	Carboplatin	Intravenous
DRUG	Pemetrexed	Intravenous
DRUG	Cetuximab	Intravenous

Timeline

• Start date: 2022-08-03
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2022-06-08
• Last updated: 2026-03-12

Locations

52 sites across 10 countries: United States, Australia, China, France, Germany, Hong Kong, Italy, Japan, South Korea, Spain

Regulatory

• FDA-regulated drug study