RNK08954 / Ranok Therap - LARVOL DELTA

Clinical activity and safety of RNK08954 in advanced non–small cell lung cancer (NSCLC) patients with KRAS G12D mutation (NCT06667544). (ASCO 2026) - P1/2 | "RNK08954 was well tolerated and displayed promising antitumor activity in pts with KRAS G12D-mutant NSCLC. The study supports further evaluation either as monotherapy or in combination with standard of care and/or novel agents."

Clinical • First-in-human • Metastases • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

A phase 1, 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. (ASCO-GI 2026) - P1/2 | "In pts with KRAS G12D mutation, the treatment with RNK08954 was well tolerated and demonstrated encouraging clinical activity, particularly in PDAC patients. The phase 1B is now enrolling patients in these indications."

Clinical • First-in-human • Metastases • P1 data • PK/PD data • Gastrointestinal Cancer • Oncology • Solid Tumor • KRAS

Preclinical Characterization and Clinical Activity of RNK08954, a Highly Selective and Orally Bioavailable KRAS G12D Inhibitor. (PubMed, Cancer Discov) - "In patients with non-small cell lung cancer (NSCLC), the objective response rate (ORR, unconfirmed) is 58.33%, and in patients with pancreatic ductal adenocarcinoma (PDAC) the ORR (unconfirmed) was 33.33% in the 1000-1200mg cohort. This study supports the clinical potential of RNK08954 in patients with KRAS G12D mutation either as a single agent or in combination."

Journal • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

Ranok Therapeutics Announces the Publication of Positive Phase 1a Clinical Results for KRAS G12D Inhibitor RNK08954 in Cancer Discovery (PRNewswire) - "The study evaluated the safety, tolerability, and clinical activity of RNK08954 in patients harboring KRAS G12D mutation across multiple sites in China. The study enrolled patients with advanced solid tumors, primarily focusing on safety and the determination of the Recommended Dose for Expansion. A total of 36 patients were evaluable for clinical activity. The overall objective response rate (ORR) was 28%, with a disease control rate (DCR) of 86%. Notably, patients with non-small cell lung cancer (NSCLC) achieved an ORR of 58.33% and a DCR of 100%."

P1 data • Non Small Cell Lung Cancer

IN10018 in Combination With RNK08954 for the Treatment of KRASG12D Mutation-Positive Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=92 | Recruiting | Sponsor: InxMed (Shanghai) Co., Ltd.

New P1/2 trial • Oncology • Solid Tumor • KRAS

A Study to Evaluate the Food Effect on RNK08954 in Healthy Participants, and the Mass Balance Study of [14C]RNK08954 in Healthy Adult Male Subjects (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Ranok Therapeutics (Hangzhou) Co., Ltd.

New P1 trial

To Evaluate the Safety and Efficacy of RNK08954 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma. (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Ranok Therapeutics (Hangzhou) Co., Ltd.

New P2 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • KRAS

TRIAD1: A Study of RNK08954 in Subjects With Advanced Solid Tumors With KRAS ((Kirsten Rat Sarcoma) G12D Mutation (clinicaltrials.gov) - P1/2 | N=152 | Recruiting | Sponsor: Ranok Therapeutics (Hangzhou) Co., Ltd. | Initiation date: Jun 2025 ➔ Oct 2024

Trial initiation date • Oncology • Sarcoma • Solid Tumor • KRAS

TRIAD1: A Study of RNK08954 in Subjects With Advanced Solid Tumors With KRAS ((Kirsten Rat Sarcoma) G12D Mutation (clinicaltrials.gov) - P1/2 | N=152 | Recruiting | Sponsor: Ranok Therapeutics (Hangzhou) Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2024 ➔ Jun 2025

Enrollment open • Trial initiation date • Oncology • Sarcoma • Solid Tumor • KRAS