Study of D3S-001 for Advanced KRAS p.G12C Solid Tumors

This study is testing a new oral drug called D3S-001, either alone or with other approved cancer drugs like Pembrolizumab, Cisplatin, Carboplatin, or Pemetrexed. It's for people with advanced solid tumors that have a specific genetic change called a KRAS p.G12C mutation. To join, your tumor must have this mutation, and your cancer must be progressing. The main goals are to see how safe D3S-001 is and what side effects it might cause. Researchers will also look at how the drug moves through your body and if it helps shrink tumors. About 442 people are expected to join this study.

Study design
This is a Phase 1/2 study, meaning it's an early-stage trial. It is open-label, so you and your doctors will know which treatment you are receiving.
What's involved
You would take D3S-001 daily by mouth in 21-day cycles. The study will monitor you for side effects from your first dose until 30 days after your last dose.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for side effects for 30 days after your last dose of study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05410145

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
D3 Bio (Wuxi) Co., Ltd
~442 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:D3S-001PembrolizumabCisplatinCarboplatinPemetrexedCetuximab

At a glance

Recruiting sites
51 of 52 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Adverse Events (AEs)
Measured over From first dose until 30 days after the last dose (or specified in the protocol).
+1 more outcome measured
KRAS P.G12C
52 sites across 31 states
Spain6
Italy5
France4
China3
South Korea3
California2
Victoria2
Hubei2
  • Cheng Chen, MD · STUDY_DIRECTOR · D3 Bio (Wuxi) Co., Ltd

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  • Number of Participants With Adverse Events (AEs)From 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.