Ranok Therapeutics has announced the publication of preliminary clinical findings from its Phase 1a study evaluating RNK08954, an investigational oral small-molecule inhibitor targeting KRAS G12D mutations in advanced solid tumors. The results were published in the peer-reviewed journal Cancer Discovery and highlighted encouraging clinical activity along with a manageable safety profile.

The multicentre study was conducted across several sites in China and assessed the safety, tolerability and preliminary efficacy of RNK08954 in patients with KRAS G12D-mutated advanced solid tumors. The trial primarily focused on identifying the recommended dose for expansion while evaluating clinical responses in treated patients.

According to the company, 36 patients were evaluable for clinical activity. The study reported an overall objective response rate (ORR) of 28 percent and a Disease Control Rate (DCR) of 86 percent. Particularly notable results were observed in patients with Non-Small Cell Lung Cancer (NSCLC), where the therapy achieved an ORR of 58.33 percent and a disease control rate of 100 percent.

RNK08954 was generally well tolerated during the study. Most treatment-related adverse events were mild to moderate gastrointestinal side effects and decreased appetite. The company reported that no dose-limiting toxicities were observed during the dose-escalation phase of the trial.

Professor Song Zhengbo, Director of the Phase I Clinical Trial Unit at Zhejiang Cancer Hospital and the study’s principal investigator, said the findings represent an important step toward the clinical validation of KRAS G12D-targeted therapies. He noted that the study could help strengthen the foundation for future pivotal clinical trials in precision oncology.

Dr. Iman Elhariry, Chief Medical Officer at Ranok Therapeutics and co-author of the publication, said the strong response rates observed in the NSCLC cohort validate the company’s approach of selectively targeting the Switch II pocket of KRAS G12D. He added that the company has already initiated a Phase 1b expansion study to further evaluate RNK08954 both as a monotherapy and in combination regimens across NSCLC, pancreatic cancer and additional indications.

Dr. Weiwen, Founder and CEO of Ranok Therapeutics, said advances in KRAS inhibitor development have been made possible through years of progress in structural biology and medicinal chemistry. He added that the latest clinical findings would support the company’s continued efforts to unlock the therapeutic potential of RNK08954 for patients with limited targeted treatment options.

KRAS G12D mutations are among the most common oncogenic drivers in several difficult-to-treat cancers, including pancreatic, colorectal and lung cancers. Researchers have historically considered KRAS mutations challenging therapeutic targets, making recent progress in KRAS inhibitor development a major focus in precision oncology.