DN022150 / Shanghai De Novo Pharmatech, Jiangxi Qingfeng Pharma - LARVOL DELTA

The KRAS targeting revolution in metastatic pancreatic cancer: insights from the landmark RASolute-302 trial and emerging allele-specific strategies at ASCO 2026. (PubMed, J Hematol Oncol) - "This correspondence highlights how the first-in-class pan-RAS (ON) inhibitor daraxonrasib (RMC-6236) virtually doubled median overall survival (13.2 vs. 6.6 months) and progression-free survival compared to chemotherapy in second-line mPDAC, establishing a new standard of care...These include the selective KRAS G12D inhibitor DN022150 and promising horizontal combinations pairing the G12D inhibitor HRS-4642 with either the anti-PD-L1 antibody adebrelimab or a Nectin-4-targeted antibody-drug conjugate (ADC). Furthermore, we address the KRAS G12C cohort where farnesyl transferase co-inhibition (darlifarnib plus adagrasib) successfully bypasses adaptive resistance. Ultimately, the therapeutic landscape of mPDAC is transitioning toward tailored genomic frameworks. Future success will rely on optimizing the clinical sequencing or combination of pan-RAS and allele-specific agents, guided by real-time liquid biopsies, to permanently dismantle resistance and transform mPDAC into..."

IO biomarker • Journal • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

Phase I/IIa study of DN022150, a novel selective noncovalent small molecule KRAS G12D inhibitor in patients with advanced KRAS G12D–mutant solid tumors. (ASCO 2026) - P | "DN022150 demonstrated favorable safety and tolerability profiles in patients with KRAS G12D-mutated advanced solid tumors, with no dose-limiting toxicities observed and manageable TRAEs. The agent showed potent antitumor activity, confirming its precise targeting of the KRAS G12D mutation. These results position DN022150 as a promising novel therapy for this molecularly defined population."

Clinical • First-in-human • Metastases • P1/2 data • Leukopenia • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

Trial of DN022150 Versus Chemotherapy in Previously Treated Advanced Pancreatic Cancer With KRAS G12D Mutation (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: Jiangxi Kvvit Pharmaceutical Co., Ltd.

Monotherapy • New P3 trial • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

The KRAS G12D Inhibitor Pipeline Grows. (PubMed, Cancer Discov) - "At this year's ASCO Annual Meeting, investigators also presented encouraging early clinical data for several KRASG12D-selective inhibitors, including RNK08594, GFH375, and DN022150, suggesting that this type of drug could play a role in the treatment of several solid tumors, such as pancreatic ductal adenocarcinoma and non-small cell lung cancer."

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

Clinical Trial of DN022150 Combined With AG Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12D Mutation (clinicaltrials.gov) - P2/3 | N=465 | Not yet recruiting | Sponsor: Jiangxi Kvvit Pharmaceutical Co., Ltd.

New P2/3 trial • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

Phase I/IIa Study evaluating the safety, tolerability, pharmacokinetics, and efficacy of DN022150 in patients with advanced solid tumors Harboring KRASG12D mutation (ChiCTR) - P1/2 | N=181 | Recruiting | Sponsor: Zhongshan Hospital ,Fudan University; Zhongshan Hospital ,Fudan University | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • KRAS

Phase I/IIa Study evaluating the safety, tolerability, pharmacokinetics, and efficacy of DN022150 in patients with advanced solid tumors Harboring KRASG12D mutation (ChiCTR) - P1/2 | N=181 | Not yet recruiting | Sponsor: Zhongshan Hospital ,Fudan University; Zhongshan Hospital ,Fudan University

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