On the afternoon of March 17, 2025, Nanjing Tianyinshan Hospital welcomed the launch of two clinical trial projects, bringing hope to thyroid cancer and melanoma patients. The meeting was co-chaired by Professor Qin Shukui, an internationally and domestically renowned oncology clinical research expert, and Director Chen Yingxia, Director of the Institutional Office. Director Zhang Yu, the PI of the project, and her research team, the managers of the Institutional Office, the head of the sponsor, Beijing Scitech-MQ Pharmaceuticals Limited (Scitech Pharma), and the head of the CRO, Shanghai Lingxian Medical Limited (Lingxian Med), as well as other relevant personnel, participated in the meeting.
The two clinical trials being initiated are “A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of ST-1898 Tablets for the Treatment of Locally Advanced or Metastatic Radioiodine-Refractory Differentiated Thyroid Cancer that Has Failed at Least First-Line TKI Systemic Treatment” and “Phase Ib/II clinical trial of ST-1898 tablets in patients with non-surgically resectable or metastatic melanoma on the basis of safety, tolerability, pharmacokinetics and preliminary anti-tumor activity”. ST-1898 is a multi-target tyrosine kinase inhibitor developed by Scitech Pharma via AI platform with independent intellectual property rights, which can inhibit c-MET、VEGFR-2、PDGFRa、RET、c-KIT、TRK-A、TRK-B、AXL and other targets.
The two clinical studies are led by Professor Lin Yansong of Peking Union Medical College Hospital and Professor Guo Jun of Beijing Cancer Hospital, respectively, and our center is led by Dr. Zhang Yu, Director of Department of Comprehensive Medical Oncology, as the principal investigator. The anti-tumor efficacy and safety of ST-1898 tablets for the treatment of locally advanced or metastatic radioiodine-refractory differentiated thyroid cancer that has failed at least one line of TKI systemic therapy will be further evaluated, as well as the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in patients with non-operable resectable or metastatic acromegaly melanoma.
Professor Qin Shukui gave an opening speech for this meeting, introducing the progress of basic research and clinical research on thyroid cancer and melanoma, especially pointing out that the mechanism of melanoma in China is different from that of foreign populations, and that unlike malignant melanoma caused by sunlight damage in foreign countries, acral melanoma and mucosal melanoma are common in China, and only patients with acral melanoma were included in the current study. Taking the protocol design as the starting point, the design ideas of the two research protocols were explained in detail for the participants. Then, the medical team of the sponsor, Scitech Pharma, introduced the pharmacological mechanism and innovative targets of ST-1898 tablets, and gave a detailed introduction to the participants on the protocol design of the two clinical studies, the criteria for subject enrollment, the trial process, the principles of dosing regimen and dosage adjustment, the means of evaluating the therapeutic efficacy, as well as the benefits and risks involved in the informed consent document, and other contents. Participating researchers discussed the implementation details of the clinical trial and the enrollment criteria in depth and asked related questions, which were answered by Professor Qin Shukui and the sponsor. Director Zhang Yu and the research team indicated that they will actively screen the cases, conduct the study in strict accordance with the study protocol and GCP requirements, and do a good job in protecting the rights and safety of the subjects. Finally, Director Chen Yingxia summarized the meeting, emphasized the trial precautions, especially the control of research details, and said that our center will actively select suitable subjects, and the researchers will promote the trial efficiently with a rigorous scientific research attitude and strict implementation of GCP principles.
The successful convening of this kick-off meeting signifies that the clinical trial work of Nanjing Tianyinshan Hospital has entered a new stage. The tumor types involved in the trial project cover digestive tract malignant tumors, lung cancer, malignant pleural and abdominal fluid, thyroid cancer and malignant melanoma. We believe that under the leadership of Professor Qin Shukui and the joint efforts of the research team of Nanjing Tianyinshan Hospital, we will try our best to bring new hope to more tumor patients.
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