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

NCT06667544 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2025-10-30

No results posted yet for this study

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).

Conditions

  • KRAS G12D Mutation

Interventions

DRUG

RNK08954-01

Once daily oral treatment for a 3 week cycle

Sponsors & Collaborators

  • Ranok Therapeutics (Hangzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhengbo Song, MD · Zhejiang Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-08
Primary Completion
2026-12-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • China

Study Locations

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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 NCT06667544 on ClinicalTrials.gov