FGFRs antagonists(Fibroblast growth factor receptors antagonists), M-CSF inhibitors(Macrophage Colony Stimulating Factor 1 inhibitors), VEGFR2 antagonists(Vascular endothelial growth factor receptor 2 antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [3]

Active Indication

Metastatic Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaBile Duct Neoplasms+ [12]

Inactive Indication

Transitional Cell Carcinoma

Originator Organization

Shanghai Institute of Materia Medica Chinese Academy of Sci

Active Organization

Shanghai Institute of Materia Medica Chinese Academy of SciShanghai Runshi Pharmaceutical Technology Co., Ltd.

CSPC Pharmaceutical Group Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Clinical Trials associated with Simmitinib

NCT06656091 / Not yet recruitingPhase 3

Simmitinib Versus Investigator's Choice of Chemotherapy for Participants With Advanced or Metastatic Oesophageal Squamous Cell Carcinoma : a Randomised, Open-label, Multicentre, Phase 3 Study

To evaluate the overall survival of simmitinib versus investigator's choice of chemotherapy for Participants with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression after first-line standard therapy.

Start Date31 Oct 2024

Sponsor / Collaborator

Shanghai Runshi Pharmaceutical Technology Co., Ltd.

ChiCTR2400089300 / SuspendedPhase 1IIT

An open-label and multicenter Phase ? Clinical Study to Evaluate the Safety and Efficacy of SYS6010 in combination with Enlonstobart and Simmitinib in patients with advanced esophageal cancer

Start Date13 Sep 2024

Sponsor / Collaborator-

NCT06577376 / Not yet recruitingPhase 1/2

A Multicenter, Open-label Phase I/II Clinical Study to Evaluate the Safety and Efficacy of Simmitinib or Irinotecan Liposomes Combined With DP303c Injection in the Treatment of HER2 Expressing Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

This study is divided into two parts: Cohort 1 and Cohort 2. Cohort 1 includes the dose escalation phase of DP303c combined with simmitinib, as well as the randomized controlled trial (RCT) phase of DP303c combined with simmitinib; Cohort 2 includes dose escalation/dose extension of DP303c combined with irinotecan liposomes, as well as RCT stage of DP303c combined with irinotecan liposomes.

Start Date26 Aug 2024

Sponsor / Collaborator

Shanghai Runshi Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Simmitinib

100 Translational Medicine associated with Simmitinib

100 Patents (Medical) associated with Simmitinib

Literatures (Medical) associated with Simmitinib

01 May 2022·Bioanalysis

Development and Validation of a High Performance Liquid Chromatography–MS/MS Method for Determination of SOMCL-15-290 in a First-in-Human Study

Article

Author: Yu, Mengyang ; Wu, Xiaofei ; Zhang, Fan ; Liu, Aijing ; Wang, Hongyun

Background: SOMCL-15-290 is a novel inhibitor that targets FGF receptor, CSF1 receptor and VEGF receptor (kinase insert domain receptor). Aim: This study was aiming at developing a specific high performance liquid chromatography–MS/MS method for quantifying SOMCL-15-290 in human plasma and supporting the first-in-human study. Methods: Plasma samples were prepared using the protein precipitation method and separated on a C18 110A column with acetonitrile and 0.2% formic acid solution as mobile phases. Quantification of SOMCL-15-290 was operated on an Xevo-TQS triple quadrupole tandem mass spectrometer in electrospray ionization positive mode. Results & conclusion: 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.

100 Deals associated with Simmitinib

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Esophageal Squamous Cell Carcinoma	Phase 3	-	Shanghai Runshi Pharmaceutical Technology Co., Ltd.	31 Oct 2024
Esophageal Squamous Cell Carcinoma	Phase 3	CN	Shanghai Institute of Materia Medica Chinese Academy of Sci	13 Sep 2024
HER2-Low Breast Carcinoma	Phase 2	CN	Shanghai Institute of Materia Medica Chinese Academy of Sci	22 Aug 2024
HR-positive/HER2-low Solid Tumors	Phase 2	CN	Shanghai Runshi Pharmaceutical Technology Co., Ltd.	30 Jan 2024
Advanced Malignant Solid Neoplasm	Phase 2	CN	Shanghai Institute of Materia Medica Chinese Academy of Sci	07 Dec 2023
Advanced Malignant Solid Neoplasm	Phase 2	CN	Shanghai Runshi Pharmaceutical Technology Co., Ltd.	07 Dec 2023
Bile Duct Neoplasms	Phase 2	CN	CSPC Pharmaceutical Group Ltd.	-
Endometrial Carcinoma	Phase 2	CN	CSPC Pharmaceutical Group Ltd.	-
squamous cell lung carcinoma	Phase 2	CN	CSPC Pharmaceutical Group Ltd.	-
Stomach Cancer	Phase 2	CN	CSPC Pharmaceutical Group Ltd.	-

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04058587 (ASCO2024) Manual	Phase 1	Advanced Malignant Solid Neoplasm FGF3 \| FGF4 \| FGF19	98	Simmitinib 4 mg QD	(abbmmurqpw) = MTD was not achieved htxvkiokjw (jtnqcmlpkk ) View more	Positive	24 May 2024
				Simmitinib 6 mg QD

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