[Translation] A multicenter, open-label Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of SSGJ-705 for injection in patients with advanced or metastatic HER2-expressing solid tumors

Part1部分，评价SSGJ-705在标准治疗失败的晚期或转移性HER2表达实体瘤患者中的安全性、耐受性、PK特征和潜在疗效，并确定SSGJ-705的最大耐受剂量（MTD）和II期推荐剂量（RP2D）；Part2部分，评价SSGJ-705在标准治疗失败的晚期或转移性HER2表达实体瘤患者中的潜在抗肿瘤作用（ORR）

[Translation]

Part 1 will evaluate the safety, tolerability, PK characteristics and potential efficacy of SSGJ-705 in patients with advanced or metastatic HER2-expressing solid tumors who have failed standard treatment, and determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of SSGJ-705; Part 2 will evaluate the potential anti-tumor effect (ORR) of SSGJ-705 in patients with advanced or metastatic HER2-expressing solid tumors who have failed standard treatment

Start Date-

Sponsor / Collaborator

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

NCT06390774 / RecruitingPhase 1

A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SSGJ-705 Monotherapy in Patients with Advanced Malignant Tumors

This study was an open-label phase I study to evaluate the safety, tolerability, PK profile and potential efficacy of SSGJ-705 as a single agent in patients with advanced malignancies.

Start Date30 May 2024

Sponsor / Collaborator

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

NCT05145179 / Not yet recruitingPhase 1

A Phase I, Multicenter, Open-Label, First-in-Human Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Potential Anti-tumor Effects of SSGJ-705 in Patients With Advanced or Metastatic HER2-expressing Solid Tumors

The study will consist of two parts: a dose-escalation part (Part 1) and a dose expansion part (Part 2). In both study parts, SSGJ-705 will be administered，the administration duration may be adjusted based on outcomes of previous patients if necessary) followed by safety, PK, PD, potential anti tumor effects and immunogenicity evaluation.

Start Date01 Dec 2021

Sponsor / Collaborator

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

100 Clinical Results associated with SSGJ-705

100 Translational Medicine associated with SSGJ-705

100 Patents (Medical) associated with SSGJ-705

Literatures (Medical) associated with SSGJ-705

01 Dec 2011·NanotoxicologyQ3 · MEDICINE

Cd/Se/Te-based quantum dot 705 modulated redox homeostasis with hepatotoxicity in mice

Q3 · MEDICINE

Article

Author: Wan-Hsuan Chang ; Chien-Jen Wang ; Han Chang ; Ming-Hsien Tsai ; Louis W Chang ; Chung-Shi Yang ; Pinpin Lin ; Mo-Hsiung Yang ; Chia-Hua Lin

The objective of this study was to investigate whether quantum dot 705 (QD705) disrupts the cellular antioxidant systems leading to hepatotoxicity in mice. Mice were intravenously injected with QD705 and then sacrificed at week 12 or 16. Homeostasis of antioxidant-related metals, antioxidant activities, induction of oxidative stress, and toxicity in the liver were investigated. Although no histopathological change was observed, a time- and dose-dependent increase in metallothionein expression and reduction in liver function was noticed. Increased copper, zinc, and selenium levels and enhancements of the trace metal-corresponding transporters were noted at week 12. At week 16, a decline of selenium from its elevated level at week 12 was observed, which was accompanied by changes in glutathione peroxidase activity as well as in redox status. A significant reduction in superoxide dismutase activity was observed at 16 weeks. Furthermore, a corresponding elevation of heme oxygenase-1 expression, 8-oxo-7,8-dihydro-2'-deoxyguanosine, interleukin-6 and tumor necrosis factor-alpha suggested the presence of oxidative stress, oxidative DNA damage and inflammation.

01 Aug 2008·Environmental Science & TechnologyQ1 · ENVIRONMENTAL SCIENCE & ECOLOGY

Computational and Ultrastructural Toxicology of a Nanoparticle, Quantum Dot 705, in Mice

Q1 · ENVIRONMENTAL SCIENCE & ECOLOGY

Article

Author: Tsai, Ming-Hsien ; Chen, Jein-Wen ; Yang, Chung Shi ; Chang, Louis W. ; Chang, Han ; Wu, Jui-Pin ; Redding, Laurel ; Wang, Hsiu-Jen ; Lin, Pinpin ; Yang, Raymond S. H. ; Kuo, Yu-Chun ; Yeh, Teng-Kuang

We conducted pharmacokinetic and toxicology studies on Quantum Dot 705 (QD705) in male ICR mice for up to 6 months after a single intravenous dose. Time-course sacrifices were carried out at 1, 4, and 24 h; 3, 7, 14, and 28 days; and 6 months on groups of six mice per time point. Mass balance studies were also carried out at 24 h, 28 days, and 6 months. Using inductively coupled plasma mass spectrometry, various tissues, urine, and feces were analyzed for cadmium (Cd111), which is a major (46%) component of QD705. On the basis of these experimental studies, a physiologically based pharmacokinetic computer simulation model was developed with excellent predictive capability for the time-dependent kinetic and distributional changes of QD705 in tissues. QD705 persisted and accumulated in the spleen, liver, and kidneys for at least 28 days with little or no disposition but was gradually and partially eliminated by 6 months. Although histological alterations of the spleen, liver, and kidney by light microscopy are unremarkable, investigation using electron microscopy on numerous renal samples revealed definitive mitochondrial alterations in renal tubular epithelial cells at 28 days and 6 months postdosing. Health implications and potential beneficial applications of QD705 are suggested.

100 Deals associated with SSGJ-705

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced cancer	Phase 1	CN	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	15 Apr 2024
Metastatic Solid Tumor	Phase 1	-	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	01 Dec 2021
HER2 Positive Solid Tumors	Phase 1	CN	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	22 Nov 2021
Metastatic breast cancer	Phase 1	-	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	-
Stomach Cancer	Phase 1	-	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	-
Solid tumor	Preclinical	CN	Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.	29 Sep 2021

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