A Study of RNK08954 in Subjects With Advanced Solid Tumors With KRAS ((Kirsten Rat Sarcoma
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 G1
| Condition(s) | KRAS G12D Mutation |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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). |
| Who can participate | Inclusion Criteria: 1. Must be 18 years of age or older. 2. Must have pathologically documented locally advanced or metastatic malignancy harboring KRAS G12D mutations identified through deoxyribonucleic acid (DNA) sequencing of tumor tissues or circulating deoxyribonucleic acid (ctDNA) performed locally. 3. Must have received prior standard therapy appropriate for their tumor type, or in the opinion of the investigator, would be unlikely to derive further clinically meaningful benefit from appropriate standard of care therapy. 4. Must have measurable lesion(s) per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 by Computed tomography (CT) scan with contrast (magnetic resonance imaging (MRI), if the patient is allergic to contrast media). * Measurable disease may be in t |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Ranok Therapeutics (Hangzhou) Co., Ltd. |
| Locations | Nanning, Guangxi, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Hangzhou, Zhejiang, China; Shanghai, China; Shanghai, China |
| Start date | 2024-11-08 |
| NCT ID | NCT06667544 |
| Official listing | https://clinicaltrials.gov/study/NCT06667544 |