HRS-4642 / Jiangsu Hengrui Pharma - LARVOL DELTA

Clinical Trial of HRS-4642 Plus SHR-A2102 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=32 | Not yet recruiting | Sponsor: Henan Cancer Hospital

New P1/2 trial • Solid Tumor

An Exploratory Clinical Study of HRS-4642 in Combination With Immunotherapy and Chemotherapy for Pancreatic Cancer (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Shanghai Zhongshan Hospital

New P2 trial • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

A Study of HRS-4642 Monotherapy or in Combination With Adebrelimab in the Treatment of Advanced Biliary Tract Tumors. (clinicaltrials.gov) - P2 | N=49 | Recruiting | Sponsor: Shanghai Zhongshan Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

HRS-4642 combined with Nimotuzumab in the treatment of recurrent or metastatic pancreatic ductal adenocarcinoma with KRAS G12D mutation that has failed systemic therapy (ChiCTR) - P1/2 | N=10 | Recruiting | Sponsor: West China Hospital,Sichuan University; West China Hospital,Sichuan University

New P1/2 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CA 19-9 • KRAS

HRS-4642 Combined with Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: West China Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

New exploration of KRASG12D inhibitors and the mechanisms of resistance. (PubMed, Exp Hematol Oncol) - "developed a high-affinity, selective, long-acting, non-covalent KRASG12D-specific inhibitor and, further combined with the proteasome inhibitor carfilzomib, found that this protocol can achieve the purpose of killing mutant cell lines and inhibiting tumor growth in vitro and in vivo. Here, we aim to describe a potential novel therapy for patients with KRASG12D mutations and present the first KRASG12D-specific inhibitor to be proven as clinically effective. Different mutations of KRAS gene and mechanisms of KRAS drug resistance were also discussed."

Journal • Oncology • Solid Tumor • KRAS

HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=10 | Not yet recruiting | Sponsor: West China Hospital

New P1/2 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

HRS-4642 with Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Zhejiang University

New P2 trial • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

An exploratory study of HRS-4642 combination therapy for advanced colorectal cancer (ChiCTR) - P1/2 | N=78 | Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

New P1/2 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • KRAS

Hengrui Medicine’s innovative drug SHR-1826 for injection in combination with advanced solid tumors is approved for clinical trials [Google translation] (Jiangsu Hengrui Press Release) - "Recently, Hengrui Medicine's subsidiaries Shanghai Shengdi Pharmaceutical Co., Ltd., Shanghai Hengrui Medicine Co., Ltd. and Suzhou Shengdia Biotechnology Co., Ltd. received the 'Notice of Approval for Drug Clinical Trials' approved and issued by the National Medical Products Administration, approving the company to conduct a multicenter, open Phase IB/II clinical study on the safety, tolerability and efficacy of SHR-1826 for injection, HRS-4642 injection, adebelimumab injection, SHR-9839 for injection, SHR-8068 injection and bevacizumab injection in subjects with advanced solid tumors."

New P1/2 trial • Solid Tumor

HRS-4642 combined with gemcitabine and albumin-bound paclitaxel for neoadjuvant and adjuvant treatment of pancreatic cancer: an xploratory clinical study. (ChiCTR) - P2 | N=20 | Not yet recruiting | Sponsor: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

New P2 trial • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

A Study of HRS-4642 Monotherapy or in Combination with Adebrelimab in the Treatment of Advanced Biliary Tract Tumors. (clinicaltrials.gov) - P2 | N=49 | Not yet recruiting | Sponsor: Shanghai Zhongshan Hospital

New P2 trial • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

HRS-4642 in Combination With AG for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Ruijin Hospital

Combination therapy • New P2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CA 19-9

Anti-Tumor Efficacy of HRS-4642 and its Potential Combination with Proteasome Inhibition in KRAS G12D-Mutant Cancer (IASLC-WCLC 2024) - "(2) HRS-4642 synergizes with proteasome inhibitor carfilzomib again KRAS G12D-mutant tumors. (3) HRS-4642, or in combination with carfilzomib, has the potential to reshape the tumor immune microenvironment."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • KRAS

A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation (clinicaltrials.gov) - P1/2 | N=70 | Enrolling by invitation | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

Combination therapy • Enrollment open • Metastases • Oncology • Solid Tumor • KRAS

P3.12E.03: Antitumor effects of HRS-4642 and its potential synergy with proteasome inhibitors in KRAS G12D mutant tumors [Google translation] (Jiangsu Hengrui Press Release) - "The study found that: (1) HRS-4642 has a highly selective inhibitory effect on the activity of KRAS G12D mutant cell lines. (2) HRS-4642 has a significant anti-tumor effect in vivo. (3) HRS-4642 showed significant anti-tumor activity in 2 NSCLC patients. (4) Whole-genome CRISPR screening found that proteasome inhibitors may synergize with HRS-4642 to enhance sensitivity."

Preclinical • Oncology

Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Fudan University

Metastases • New P2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

2024 WCLC Outlook | Hengrui Medicine’s 9 innovative drugs and 11 lung cancer research projects will be unveiled on the international stage [Google translation] (Jiangsu Hengrui Press Release) - "This year, Hengrui Medicine had 11 research results of 9 innovative drugs shortlisted for the conference, of which 3 studies were selected for oral reports (Oral) and 8 studies were accepted as posters...The 9 innovative drugs include...5 unmarketed products: TROP-2 antibody-drug conjugate SHR-A1921, anti-PD-L1/TGF-βRII dual antibody SHR-1701, IL-15 fusion protein SHR-1501, KRASG12D inhibitor HRS-4642, and multi-target receptor tyrosine kinase inhibitor famitinib."

Clinical data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Exploratory Clinical Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=35 | Recruiting | Sponsor: Fudan University | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

A Study of HRS-4642 in Combination With Antineoplastic Agents in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=118 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Combination therapy • Metastases • New P1/2 trial • Oncology • Solid Tumor

HRS-4642: The next piece of the puzzle to keep KRAS in check. (PubMed, Cancer Cell) - "describe a novel KRASG12D inhibitor, HRS-4642, that shows potent and selective anti-tumor activity across various models and synergizes with proteasome inhibitors. Responses have also been observed in patients during an ongoing phase 1 trial."

Journal • Oncology • KRAS

Anti-tumor efficacy of HRS-4642 and its potential combination with proteasome inhibition in KRAS G12D-mutant cancer. (PubMed, Cancer Cell) - "Additionally, HRS-4642, either as a single agent or in combination with carfilzomib, reshaped the tumor microenvironment toward an immune-permissive one. In summary, this study provides potential therapies for patients with KRAS G12D-mutant cancers, for whom effective treatments are currently lacking."

Journal • Oncology • Solid Tumor • KRAS

Anti-tumor efficacy of HRS-4642 and its potential combination with proteasome inhibition in KRAS G12D-mutant cancer (Cancer Cell) - "HRS-4642 demonstrated robust efficacy against KRAS G12D-mutant cancers both in vitro and in vivo. Importantly, in a phase 1 clinical trial, HRS-4642 exhibited promising anti-tumor activity in the escalating dosing cohorts....We further observed that the proteasome inhibitor, carfilzomib, improved the anti-tumor efficacy of HRS-4642. Additionally, HRS-4642, either as a single agent or in combination with carfilzomib, reshaped the tumor microenvironment toward an immune-permissive one."

Review • Solid Tumor

Exploratory Clinical Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov) - P1/2 | N=35 | Not yet recruiting | Sponsor: Fudan University

New P1/2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

A Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation (clinicaltrials.gov) - P1/2 | N=70 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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