CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 442 target
Drug / intervention
D3S-001 +5 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing
  • ✓Documented KRAS p.G12C mutation identified within the last 5 years by local test on tumor tissue or blood
  • ✓Measurable disease per RECIST v1.1
  • ✓ECOG performance status 0 or 1
Key exclusion· 5
  • ✕Prior treatment without adequate washout periods as defined in protocol
  • ✕Uncontrolled intercurrent illness including ongoing/active infection, uncontrolled cardiovascular disease, serious chronic gastrointestinal conditions with diarrhea, or psychiatric illness/social situations limiting compliance
  • ✕Unresolved treatment-related toxicities from prior anticancer therapy of NCI CTCAE Grade ≥2 (except vitiligo or alopecia)
  • ✕Active gastrointestinal disease or other condition that could interfere significantly with absorption, distribution, metabolism, or excretion of oral therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05410145
NCT05410145Phase 2RecruitingOn TrackUpdated 3mo ago
Long Recruiting
CompareCT.gov

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

D3 Bio (Wuxi) Co., Ltd·interventional·Posted Jun 8, 2022·Updated Mar 12, 2026

In Brief

A Phase 2 clinical trial evaluating D3S-001, Pembrolizumab, and 4 other interventions for KRAS P.G12C. Currently recruiting, targeting 442 participants across 52 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKRAS P.G12C
CountriesAustralia, China, France, Germany, Hong Kong, Italy, Japan, South Korea, Spain, United States
Collaborators--

Timeline

Phase 2Recruiting
20232024202520262027
First PostedJun 8, 2022
Enrollment StartAug 3, 2022
Primary CompletionApr 1, 2027
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 4.1 years agoPrimary completion in 9 months

Interventions

D3S-001drug

Oral

Pembrolizumabdrug

Intravenous

Cisplatindrug

Intravenous

Carboplatindrug

Intravenous

Pemetrexeddrug

Intravenous

Cetuximabdrug

Intravenous