Clinical Trial

A Study of RNK08954 in Subjects With Advanced Solid Tumors With KRAS ((Kirsten Rat Sarcoma) G12D Mutation

Study acronym: TRIAD1
Recruiting Phase 1/2
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Summary
This is a first in human (FIH), Phase 1/2 open-label multi-center, dose escalation and expansion study to evaluate the safety, tolerability and pharmacokinetics of RNK08954 to determine the optimal dose and recommended dose for expansion and evaluate clinical activity in patients with advanced solid tumors with KRAS G12D mutation. This is a 2-part study: dose exploration/indication expansion and dose optimization ( to identify a dose that preserves clinical benefit with optimal tolerability).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-10-29; most recent amendment 2025-10-28.
Status change: Not Yet Recruiting → Recruiting 2025-04-02
Trial Details
NCT Number NCT06667544
Lead Sponsor Ranok Therapeutics (Hangzhou) Co., Ltd.
Conditions KRAS G12D Mutation
Enrollment 152 participants
Start Date 2024-11-08
Primary Completion 2026-12 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2025-10-30