Health Trials

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

ConditionKRAS P.G12C
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorD3 Bio (Wuxi) Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.

Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.

Subject must have measurable disease per RECIST v1.1.

Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Disqualifiers

None

Trial design

Treatments tested in this trial

  • D3S-001
  • Pembrolizumab
  • Cisplatin
  • Carboplatin
  • Pemetrexed
  • Cetuximab

Treatment groups

442 Participants
are divided into 4 treatment groups

Locations

52
Australia
D3 Bio Investigative Site 01022109, SydneyNew South Wales, Australia
D3 Bio Investigative Site 01013144, MalvernVictoria, Australia
D3 Bio Investigative Site 01053000, MelbourneVictoria, Australia
D3 Bio Investigative Site 01036009, NedlandsWestern Australia, Australia

Sponsors and collaborators

D3 Bio (Wuxi) Co., Ltd

Lead sponsor

Source ClinicalTrials.gov