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

NCT05410145 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2026-03-12

No results posted yet for this study

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

DRUG

D3S-001

Oral

DRUG

Pembrolizumab

Intravenous

DRUG

Cisplatin

Intravenous

DRUG

Carboplatin

Intravenous

DRUG

Pemetrexed

Intravenous

DRUG

Cetuximab

Intravenous

Sponsors & Collaborators

  • D3 Bio (Wuxi) Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Cheng Chen, MD · D3 Bio (Wuxi) Co., Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-03
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05410145 on ClinicalTrials.gov