RecruitingPhase 1Phase 2NCT06667544

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

A Phase 1/2, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of RNK08954 in Patients With Advanced Solid Tumors With a KRAS G12D Mutation TRIAD1 (Trial of RNK08954 In KRAS G12D Mutation)


Sponsor

Ranok Therapeutics (Hangzhou) Co., Ltd.

Enrollment

152 participants

Start Date

Nov 8, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase study testing a new drug called RNK08954 in people with advanced or metastatic solid tumors that have a specific genetic mutation called KRAS G12D. This mutation is found in several cancers including pancreatic, colon, and lung cancer. The study aims to find the safest and most effective dose. **You may be eligible if...** - You are 18 or older - Your tumor has been confirmed to have the KRAS G12D mutation (detected by genetic testing) - You have already tried standard treatments that are no longer working - You have measurable tumors on scans - You are in good health (ECOG 0–1) and have adequate organ function - You can swallow pills **You may NOT be eligible if...** - Your tumor tissue sample is not available for testing - Your blood counts or organ function are outside acceptable ranges - You have unresolved serious side effects from prior cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRNK08954-01

Once daily oral treatment for a 3 week cycle


Locations(6)

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Shanghai Chest Hospital

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT06667544


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