simmitinib (SYHA1817) / CSPC Pharma - LARVOL DELTA

A phase II study of simmitinib in combination with liposomal irinotecan for second-line treatment of advanced esophageal squamous cell carcinoma (ESMO 2025) - P2 | "Two treatment-related deaths (both in arm 1) were attributed to small bowel obstruction with infection and hematemesis. Table: 2125P n (%) Arm 1 (N = 22) Arm 2 (N = 14) Arm 3 (N = 5) Any grade TRAEs 20 (90.9%) 14 (100%) 5 (100%) Grade ≥3 TRAEs 9 (40.9%) 6 (42.9%) 3 (60.0%) Diarrhea 2 (9.1%) 1 (7.1%) 0 Vomiting 2 (9.1%) 0 0 Hyponatremia 2 (9.1%) 1 (7.1%) 0 Leukopenia 2 (9.1%) 1 (7.1%) 1 (20.0%) Nausea 1 (4.5%) 1 (7.1%) 1 (20.0%) Hematemesis 1 (4.5%) 0 0 Esophagomediastinal fistula 1 (4.5%) 0 0 Small bowel obstruction 1 (4.5%) 0 0 Neutropenia 1 (4.5%) 1 (7.1%) 2 (40.0%) Febrile neutropenia 1 (4.5%) 0 0 Anemia 1 (4.5%) 1 (7.1%) 0 Hypochloremia 1 (4.5%) 0 0 Hypertriglyceridemia 1 (4.5%) 0 0 Decreased appetite 1 (4.5%) 0 0 Infection 1 (4.5%) 0 0 Hypertension 1 (4.5%) 0 0 Fatigue 0 2 (14.3%) 0 Elevation of γ-GT 0 1 (7.1%) 0 Elevation of s-ALP 0 1 (7.1%) 0 Conclusions Simmitinib in combination with liposomal irinotecan demonstrated promising efficacy in patients with ESCC,..."

Clinical • Combination therapy • Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Safety and efficacy of simmitinib in patients(pts) with advanced solid tumors: A phase I study (ESMO 2025) - P1 | "The median PFS and OS in pts with ESCC were 4.8 months (95%CI 2.1-5.7) and 9.1 months (95%CI 5.6-11.6), respectively. Conclusions Simmitinib demonstrated acceptable safety profile and promising antitumor activity in pts with advanced solid tumors, especially ESCC, supporting further investigation."

Clinical • Metastases • P1 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • CSF1R • KDR

An open-label and multicenter Phase Ⅰ Clinical Study to Evaluate the Safety and Efficacy of SYS6010 in combination with Enlonstobart and Simmitinib in patients with advanced esophageal cancer (ChiCTR) - P1 | N=60 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Henan University of Science and Technology; The First Affiliated Hospital of Henan University of Science and Technolo

Combination therapy • Metastases • New P1 trial • Esophageal Cancer • Oncology

A Study of Simmitinib Versus Chemotherapy for Participants With Advanced Oesophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P3 | N=450 | Not yet recruiting | Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd

New P3 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

A PhaseⅠ/Ⅱ Study of Simmitinib or Irinotecan Liposomes Combined With DP303c in Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=252 | Not yet recruiting | Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd

New P1/2 trial • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of Simmitinib Plus Irinotecan in Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=138 | Recruiting | Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd

Metastases • New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

First-in-human study of simmitinib, a novel tyrosine kinase inhibitor targeting FGFR1-3, KDR and CSF-1R. (ASCO 2024) - P1 | "Simmitinib showed manageable toxicity in the study and encouraging activity in esophageal squamous carcinoma. Accordingly, 6 mg 3 weeks on 1 week off was recommended for phase Ⅱ trials."

P1 data • Cardiovascular • Esophageal Cancer • Hypertension • Oncology • Solid Tumor • Squamous Cell Carcinoma • CSF1R • FGF19 • FGF4 • FGFR1 • KDR

Shanghai Runshi Pharmaceutical Technology Co., Ltd.'s application for implied license for clinical trials of drugs has been accepted [Google translation] (163.com) - "On May 27, according to the official website of CDE, Shanghai Runshi Pharmaceutical Technology Co., Ltd. and Shanghai Institute of Materia Medica, Chinese Academy of Sciences jointly applied for the drug 'Ximetinib Hydrochloride Tablets' and obtained implicit clinical trial approval, acceptance number CXHL2400288....Ximetinib Hydrochloride Tablets combined with DP303c Injection are used to treat patients with previously treated HER2-expressing locally advanced/metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma."

New trial • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of Simmitinib Plus SG001 in Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=168 | Not yet recruiting | Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd

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

A Phase I Trial of Simmitinib in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2021 ➔ Mar 2023 | Trial primary completion date: Oct 2021 ➔ Jan 2023

Enrollment open • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • VEGFA

Development and validation of a high performance liquid chromatography-MS/MS method for determination of SOMCL-15-290 in a first-in-human study. (PubMed, Bioanalysis) - "Quantification of SOMCL-15-290 was operated on an Xevo-TQS triple quadrupole tandem mass spectrometer in electrospray ionization positive mode. Results & The validated determination method of SOMCL-15-290 has proved feasible and was successfully utilized in the first-in-human study of SOMCL-15-290 in advanced solid tumor patients."

Journal • P1 data • Oncology • Solid Tumor • CSF1R • KDR