[Translation] Phase IIa multicenter, single-arm, exploratory clinical trial to investigate the efficacy and safety of dicycloplatin injection in patients with metastatic castration-resistant prostate cancer (mCRPC)

主要目的：初步探索双环铂注射液对mCRPC患者的有效性和安全性次要目的：评价双环铂注射液在mCRPC患者中多次给药的药代动力学特征及可能的活性代谢产物的探索性研究。

[Translation]

Primary objective: To preliminarily explore the efficacy and safety of dicycloplatin injection in patients with mCRPC. Secondary objective: To evaluate the pharmacokinetic characteristics of dicycloplatin injection after multiple doses in patients with mCRPC and conduct an exploratory study on possible active metabolites.

Start Date-

Sponsor / Collaborator

Beijing Sopuxingda Pharmaceutical Research Co., Ltd.

[+1]

NCT05472896

/ Unknown statusPhase 3IIT

TACE With Dicycloplatin（TP21） in Patients With Unresectable Hepatocellular Carcinoma: an Open, Parallel-controlled,Multicenter Randomized Phase III Trial

To evaluate the effectiveness and safety of TP21 injection for TACE in treatment of hepatocellular carcinoma:
1. Primary efficacy endpoint: progression-free survival (PFS), which will be assessed by the Independent Review Committee according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST).
2. Secondary efficacy endpoints: PFS, objective response rate (ORR), disease control rate (DCR), overall survival (OS), time to progression (TTP), 1-year progression-free survival, 1-year survival and 2-year survival assessed by the investigator.

Start Date09 Jun 2022

Sponsor / Collaborator

Southeast University Affiliated Zhonda Hospital

100 Clinical Results associated with Dicycloplatin

100 Translational Medicine associated with Dicycloplatin

100 Patents (Medical) associated with Dicycloplatin

890

Literatures (Medical) associated with Dicycloplatin

01 Apr 2025·Journal of Orthopaedic Research

A Micro‐CT Based Cadaveric Study Investigating Bone Density Changes During Hip Arthroplasty Surgery

Article

Author: Wilson, Paul F. ; Seemala, Vineet ; Williams, Mark A. ; King, Richard ; Palit, Arnab ; Goia, Sofia

ABSTRACTThe impact of broaching and uncemented implantation on bone density during total hip arthroplasty (THA) remains unclear. Previous studies have typically examined extracted bone sections, which may not directly correlate with outcomes in human hip systems. This study aimed to evaluate bone density changes resulting from broaching and uncemented implantation using micro‐computed tomography (μCT) on cadaveric samples. An in‐house density calibration phantom (DCP) was developed by validating the densities of polymer inserts through mass and volume measurements. Its performance was then evaluated using lamb bone in comparison with a commercial DCP (QRM‐50124). The sensitivity of density predictions to μCT scan parameters was also evaluated with the lamb bone. Additionally, density predictions from medical‐CT and μCT scans were compared using the in‐house DCP. Finally, uncemented THA procedures were performed on three cadaveric femurs, each undergoing three μCT scans at various surgical stages to assess changes in bone density. The density predictions obtained using the in‐house DCP achieved an accuracy of ±0.097 g/cc compared to QRM‐50124, with a precision of ±0.052 g/cc. The sensitivity to changes in μCT scan parameters was ±0.022 g/cc. Notably, density predictions from medical‐CT and μCT scans were similar, particularly in cortical bone. Broaching and implantation led to an average increase in bone density of 0.137 g/cc, which was attributed to the accumulation of bone debris around the bone‐implant interface. This accumulation raised the bone volume fraction, ranging from 3.31% to 20.69%, which acts as an autograft. These measurements have been made for the first time using a µCT and an in‐house DCP.

01 Feb 2025·JGH Open

Higher Absolute Lymphocyte Counts and Lower Des‐γ‐Carboxyprothrombin Levels After Treatment Initiation Are Associated With the Clinical Efficacy of Tremelimumab Plus Durvalumab Combination Therapy for Hepatocellular Carcinoma

Article

Author: Tamura, Shoji ; Hirohata, Seiya ; Yoon, Seitetsu ; Momose, Kenji ; Kado, Takuo ; Komatsu, Shohei ; Hirano, Hirotaka ; Hayashi, Hiroki ; Kim, Soo Ki ; Tanaka, Hidenori ; Kushida, Saeko ; Shiomi, Yuuki ; Tei, Hiroshi ; Ehara, Mayumi ; Kodama, Yuzo ; Matono, Tomomitsu ; Inoue, Yuta ; Kawano, Miki ; Yoshida, Ryutaro ; Yagi, Yosuke ; Fukumoto, Takumi ; Kitadai, Jun ; Nishioka, Chiharu ; Sakane, Tatsuya ; Matsuura, Takanori ; Tada, Toshifumi ; Nishi, Katsuhisa ; Yano, Yoshihiko ; Yamamoto, Atsushi ; Ueda, Yoshihide ; Yasutomi, Eiichiro

ABSTRACTBackground and AimsTremelimumab plus durvalumab (Dur/Tre) combination therapy is now a first‐line systemic therapy for advanced hepatocellular carcinoma (HCC). Because systemic therapy is not effective in some patients, it is clinically important to identify factors that could predict the response to treatment at an early stage. We investigated the factors associated with the response to Dur/Tre for advanced HCC in a clinical setting.MethodsSeventy patients (median age 74 years; 61 men) who received Dur/Tre between March 2023 and September 2024 were analyzed. We examined the factors associated with the treatment response, including pretreatment factors and factors early in treatment.ResultsThe median treatment duration was 77.5 (interquartile range [IQR] 28–187) days. The overall response and disease control rates were 25.8% and 58.1%, respectively. The median (IQR) progression‐free survival (PFS) and overall survival (OS) were 82 (61–133) and 415 (337–NA) days, respectively. Multivariable analysis revealed that higher absolute lymphocyte count (ALC) and lower des‐γ‐carboxyprothrombin (DCP) levels were significantly associated with PFS. Receiver operating characteristic curve analysis showed that the cutoff value for ALC after 4 weeks of treatment in relation to clinical efficacy was 1125/mm3. A log‐rank test using the Kaplan–Meier method showed that OS was significantly longer in patients with ALC above the cutoff and in patients whose DCP levels decreased after starting treatment.ConclusionHigher ALC and lower DCP levels after treatment initiation were associated with the clinical efficacy of Dur/Tre for advanced HCC.

01 Feb 2025·Acta Pharmacologica Sinica

Baicalein ameliorates chronic itch in ACD mice by suppressing the spinal astrocytic STAT3–LCN2 cascade

Article

Author: Zhang, Yu-Xin ; Wang, Xiao-Yu ; Ren, Xue-Qi ; Du, Li-Xia ; Mi, Wen-Li ; Yang, Yu-Fang ; Xu, Ao ; Wang, Zhi-Fei ; Yang, Ya-Yue ; Ding, Yang-Yang ; Gao, Xin-Yi ; Shu, Shi

Chronic itch is a maladaptive and debilitating symptom in patients with allergic contact dermatitis (ACD), adversely affecting their quality of life. There is a lack of effective treatments for ACD-associated uncontrollable itch. In this study, we explored the antipruritic effects of baicalein (BE), a bioactive flavonoid extracted from the root of Scutellaria baicalensis Georgi, and the underlying mechanisms in alleviating chronic itch triggered by diphenylcyclopropenone (DCP) in a mouse model of ACD. The ACD mice were intraperitoneally injected with BE (5, 30, and 60 mg·kg^-1·d^-1) for 7 days during the DCP challenge phase. The results showed that DCP-treated mice exhibited severe spontaneous scratching behaviors that was reduced after BE injections in a dose-dependent manner accompanied by inhibition of spinal astrocyte activation. We observed that the spinal astrocytic STAT3-LCN2 cascade plays a crucial role in controlling the activation of astrocytes in chronic itch. Intrathecal injection of the STAT3 inhibitor AG490 or Lcn2 siRNA significantly reduced scratching behavior and astrocyte activation in ACD mice. Moreover, BE markedly attenuated the increased phosphorylation of STAT3 (p-STAT3) and LCN2 expression in the spinal cords of ACD mice and in lipopolysaccharide-stimulated primary spinal astrocytes. Altogether, BE relieved chronic itch by suppressing the spinal astrocytic STAT3-LCN2 cascade. These findings provide a potential avenue for the management of chronic itch. Schematic summary of the main findings illustrating that BE alleviates chronic itch through suppressing the spinal astrocytic STAT3-LCN2 cascade. Specifically, BE suppresses the expression of p-STAT3 to inhibit the reactive state of astrocytes in spinal dorsal horn, and then decreases the expression of astrocytic LCN2 to alleviate chronic itch in ACD mice.

News (Medical) associated with Dicycloplatin

15 Nov 2024

·www.adalvo.com

Adalvo Secures DCP Approval for Apixaban Tablets

Adalvo announces the successful DCP approval for Apixaban Tablets. Based on the reference brand Eliquis, Apixaban is indicated for the treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). As per IQVIA, total global Apixaban sales for 2023 was $27.7Bn with a 3Y CAGR of 9%. With this approval, Adalvo is well-positioned to bring Apixaban Tablets to market as a crucial treatment option for patients suffering from DVT and PE. The DCP approval of Apixaban Tablets reflects Adalvo's commitment to delivering high-quality, differentiated treatments to our partners. Our rigorous development process ensures that we meet the highest standards of safety and efficacy, providing a reliable alternative for patients in need. There are no half-measures at Adalvo – we are always on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward. Partner Up Now!

Drug Approval

15 Nov 2024

·www.adalvo.com

Adalvo Announces Successful EU Approval for Mirabegron 50mg Prolonged-Release Tablets

Adalvo secures successful DCP approval for Mirabegron 50mg prolonged-release tablets. Developed based on the reference brand Betmiga prolonged-release tablets, Mirabegron is indicated for the treatment of urgency, increased micturition frequency, and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. According to IQVIA, Mirabegron achieved approximately $3.3Bn in global sales in 2023, with a 3-year CAGR of 2%. Additionally, registrations for Mirabegron 25mg are currently ongoing, demonstrating Adalvo's commitment to providing a wide range of treatment options. Adalvo’s success in securing this approval reflects our capabilities to develop complex, differentiated products. Building on the success of Mirabegron, Adalvo is also progressing well with the development of Mirabegron+Solifenacin, further expanding our portfolio and enhancing treatment options for patients. There are no half-measures at Adalvo – we are always on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward. Partner Up Now! Click Here To Get In Touch! © 2022-2024 Adalvo Limited. All right reserved

Drug Approval

100 Deals associated with Dicycloplatin

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Small Cell Lung Cancer	China	Beijing Sopuxingda Pharmaceutical Research Co., Ltd.	28 May 2012

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of prostate	Phase 2	China	Beijing Sopuxingda Pharmaceutical Research Co., Ltd.	18 Aug 2017
Adenocarcinoma of prostate	Phase 2	China	Beijing Xingda Science System Company	18 Aug 2017
Metastatic castration-resistant prostate cancer	Phase 2	China	Beijing Xingda Science System Company	18 Aug 2017
Metastatic castration-resistant prostate cancer	Phase 2	China	Beijing Sopuxingda Pharmaceutical Research Co., Ltd.	18 Aug 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO_GU2024	Not Applicable	Urothelial Carcinoma of the Urinary Bladder Neoadjuvant	-	Dicycloplatin	heiwadseow(ckaluruuit) = pnjestzjvf jzldssgeox (mprpaxaxwy )	-	25 Jan 2024

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