Author:Kvvit
Posted Time:2026-06-03 00:00
June 2026 – Kvvit Pharmaceuticals announced that Phase I/IIa clinical data for DN022150, a novel selective noncovalent KRAS G12D inhibitor, for patients with KRAS G12D-mutant locally advanced or metastatic solid tumors who have progressed following prior standard therapies, were presented in an Oral Presentation Session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting on June 2.
The study demonstrated promising anti-tumor responses together with a favorable safety and tolerability profile in patients with second-line and later-line (2L+) KRAS G12D-mutant pancreatic ductal adenocarcinoma (PDAC).
Presentation Title:
Phase I/IIa Study of DN022150, a Novel Selective Noncovalent Small Molecule KRAS G12D Inhibitor in Patients with Advanced KRAS G12D-Mutant Solid Tumors
Presenter: Prof. Yuejuan Cheng, Peking Union Medical College Hospital
Efficacy
As of April 5, among 31 evaluable patients with 2L+ PDAC treated with DN022150 at 650 mg administered intravenously once weekly, the objective response rate (ORR) was 41.9%, and the disease control rate (DCR) was 93.5%.
Based on the safety, pharmacokinetic (PK), and preliminary efficacy data generated to date, 650 mg has been selected as the recommended Phase II dose (RP2D) for further clinical development.
Safety
As of the data cutoff date, DN022150 demonstrated a favorable overall safety and tolerability profile.
Among 67 patients evaluable for safety, Grade ≥3 treatment-related adverse events (TRAEs) were reported in 32.8% (22/67) of patients. In the 650 mg cohort, Grade ≥3 TRAEs occurred in 27.7% (10/36) of patients. No Grade 4 or Grade 5 TRAEs were observed.
DN022150 is administered intravenously once weekly, offering a convenient dosing schedule that aligns well with current first-line treatment management practices. Based on clinical data obtained to date and publicly reported data from other oral KRAS G12D-targeted candidates, DN022150 has demonstrated a competitive safety profile, particularly with respect to gastrointestinal tolerability and the incidence of Grade ≥3 TRAEs, potentially supporting long-term treatment for patients.
About KRAS G12D Mutation and DN022150
KRAS is one of the most frequently mutated oncogenic driver genes in cancer and is estimated to occur in approximately 20%–25% of solid tumors. KRAS G12D is among the most prevalent KRAS mutation subtypes, accounting for approximately 20%–30% of all KRAS mutations, and is commonly found in pancreatic cancer, colorectal cancer, and non-small cell lung cancer (NSCLC).
In pancreatic ductal adenocarcinoma (PDAC), KRAS mutations are present in more than 85% of patients, with KRAS G12D representing approximately 35%–45% of all KRAS mutations, making it the most common KRAS mutation subtype in this disease. Currently, no targeted therapies have been approved specifically for patients with KRAS G12D mutations, underscoring a substantial unmet medical need.
DN022150 is a novel, highly selective KRAS G12D inhibitor designed to specifically bind the Switch-II pocket of mutant KRAS G12D. By engaging both the GDP-bound (OFF) and GTP-bound (ON) states of KRAS G12D, DN022150 inhibits KRAS-mediated signaling and downstream RAS-MAPK pathway activation, thereby exerting potent antitumor activity.
DN022150 is currently being evaluated in an ongoing Phase I/IIa clinical study in China. The study is led by Zhongshan Hospital, Fudan University, with Prof. Tianshu Liu serving as Principal Investigator (PI). The trial is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DN022150 in patients with advanced KRAS G12D-mutant solid tumors.
The selection of this study for an Oral Presentation Session at the 2026 ASCO Annual Meeting reflects recognition from the global oncology community of the clinical promise and innovative potential of DN022150.
Kvvit Pharmaceuticals will continue advancing the clinical development of DN022150 in pancreatic cancer and other KRAS G12D-mutant solid tumors, while exploring combination treatment strategies to expand potential patient benefit.
About Kvvit Pharmaceuticals
Founded in 2021, Jiangxi Kvvit Pharmaceuticals Co., Ltd. is the flagship small-molecule pharmaceutical business of Qingfeng Pharmaceutical Group, focused on the discovery, development, manufacturing, commercialization, and global expansion of innovative medicines.
The company is committed to delivering differentiated therapeutic solutions with meaningful clinical value and global competitiveness. Leveraging Qingfeng Pharmaceutical Group's strong industrial foundation and innovation capabilities, Kvvit Pharmaceuticals has established an integrated platform spanning drug discovery, clinical development, regulatory affairs, commercial manufacturing, and market access, enabling end-to-end capabilities from research through commercialization.
Kvvit Pharmaceuticals focuses on oncology, central nervous system (CNS) disorders, anti-infectives, and other major disease areas, while advancing a diversified portfolio of innovative medicines with proprietary intellectual property.
The company is also actively executing its global strategy through capabilities in research and development, clinical development, regulatory registration, and business development. By collaborating with pharmaceutical companies, biotechnology innovators, and academic institutions worldwide, Kvvit Pharmaceuticals is committed to bringing innovative medicines from China to patients around the globe.
Global Partnership and Business Development
Kvvit Pharmaceuticals is committed to a strategy that combines scientific innovation with global collaboration. The company is actively advancing the global development and commercialization of its innovative pipeline and pursuing opportunities for out-licensing, co-development, and commercialization partnerships worldwide.
DN022150, a next-generation highly selective KRAS G12D inhibitor independently developed by Kvvit Pharmaceuticals, has demonstrated encouraging clinical potential in KRAS G12D-mutant solid tumors. The company remains committed to advancing its global development strategy and welcomes collaboration opportunities with pharmaceutical companies, biotechnology partners, and investors to accelerate the development of innovative therapies for patients worldwide.
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