NCT06667544

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)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Ranok Therapeutics (Hangzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

In Phase 1a, enrolled subjects will receive oral RNK08954 daily after one subject completes a Lead-in Pharmacokinetic (PK) guided single-patient cohort. The dose escalation cohorts will start with one patient per cohort for the first dose levels, then will enroll a minimum of 3 patients per dose level. Five dose levels will be explored and a total of 42 patients are projected for enrollment. Phase 1b- Multiple Indications Cohorts will open once the optimal dose has been determined in Phase 1a, and will consist of 3 cohorts including colorectal cancer, pancreatic adenocarcinoma and other indications. Approximately 20 patients will be assigned to each of the 3 cohorts for a total of 60 patients. All enrollment will be concurrent. Enrolled subjects will receive oral RNK08954 daily. Phase 2 Dose Optimization Study will enroll subjects who will receive two different doses of oral RNK08954 daily to compare two different doses and further characterize the optimal dose.

Conditions

• KRAS G12D Mutation

Interventions

Type	Name	Description
DRUG	RNK08954-01	Once daily oral treatment for a 3 week cycle

Timeline

• Start date: 2024-11-08
• Primary completion: 2026-12-01
• Completion: 2027-07-01
• First posted: 2024-10-31
• Last updated: 2025-10-30

Locations

6 sites across 1 country: China

Regulatory

• FDA-regulated drug study