A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial Of JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

This study is a randomized controlled, open-label, multicenter phase III clinical study evaluating the efficacy and safety of chemotherapy selected by investigator JSKN003 s in subjects with recurrent or metastatic breast cancer who have previously failed first- or second-line chemotherapy in subjects with recurrent or metastatic breast cancer who have failed prior first- or second-line chemotherapy.
The study planned to enroll 400 subjects in a 1:1 ratio and stratified block randomization method assigned to:
Experimental group: JSKN003 monotherapy
Control group: investigator's chosen chemotherapy drug (capecitabine, gemcitabine, vinorelbine, docetaxel, albumin-bound paclitaxel, or eribulin) monotherapy

Start Date01 Dec 2023

Sponsor / Collaborator

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

CTR20232959 / RecruitingPhase 3

JSKN003对比研究者选择化疗治疗HER2低表达复发/转移性乳腺癌的随机、开放、平行对照、多中心III期临床研究

[Translation] A randomized, open, parallel-controlled, multicenter phase III clinical study of JSKN003 versus investigator-selected chemotherapy in the treatment of recurrent/metastatic breast cancer with low HER2 expression

JSKN003对比研究者选择化疗在复发/转移性乳腺癌患者中的由盲态独立中心评价的无进展生存期；JSKN003对比研究者选择化疗在复发/转移性乳腺癌患者中的总生存期；JSKN003对比研究者选择化疗在复发/转移性乳腺癌患者中的由BICR评价其他疗效指标和研究者评价疗效指标；JSKN003对比研究者选择化疗在复发/转移性乳腺癌患者中的安全性；JSKN003对比研究者选择化疗治疗复发/转移性乳腺癌的患者报告结局；评价JSKN003的药代动力学（PK）特征、免疫原性（ADA）；评价JSKN003药品暴露水平与疗效、安全性的相关性；评价生物标志物与JSKN003疗效的相关性。

[Translation]

JSKN003 compares the progression-free survival evaluated by a blinded independent center with chemotherapy selected by the investigator in patients with recurrent/metastatic breast cancer; JSKN003 compares the overall survival with chemotherapy selected by the investigator in patients with recurrent/metastatic breast cancer; JSKN003 compares other efficacy indicators evaluated by BICR and efficacy indicators evaluated by the investigator in patients with recurrent/metastatic breast cancer; JSKN003 compares the safety of chemotherapy selected by the investigator in patients with recurrent/metastatic breast cancer; JSKN003 compares patient-reported outcomes of chemotherapy selected by the investigator for the treatment of recurrent/metastatic breast cancer; evaluate the pharmacokinetic (PK) characteristics and immunogenicity (ADA) of JSKN003; evaluate the correlation between the drug exposure level of JSKN003 and its efficacy and safety; evaluate the correlation between biomarkers and the efficacy of JSKN003.

Start Date14 Nov 2023

Sponsor / Collaborator

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

NCT05744427 / RecruitingPhase 1/2

Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of JSKN003 in Chinese Subjects With Advanced Solid Tumors

This is an open, multicenter study of stage I/II in Chinese subjects with unresectable locally advanced/metastatic solid tumors. It is divided into dose escalation period and cohort expansion period. A total of 9 dose groups (Q3W on the first day of intravenous administration every three weeks) were designed in the dose escalation period. The initial dose was 1.0mg/kg, Q3W, and the observation period of DLT was 21 days. In the dose expansion phase, 5 cohorts were set up.

Start Date15 Mar 2023

Sponsor / Collaborator

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

100 Clinical Results associated with JSKN-003

100 Translational Medicine associated with JSKN-003

100 Patents (Medical) associated with JSKN-003

News (Medical) associated with JSKN-003

30 Sep 2024

·endpts.com

CSPC, Alphamab Oncology make an ADC deal; Visen’s IPO in Hong Kong

Plus, news about Sequentia Biotech: CSPC, Alphamab Oncology ink ADC deal: CSPC Pharmaceutical’s JMT-Bio Technology said it will pay RMB 400 million ($57 million) upfront and up to RMB 3.08 billion ($439 million) in total for access in China to Alphamab’s anti-HER2 bispecific ADC, called JSKN003. Visen files for IPO in Hong Kong: The six-year-old company on Monday filed to go public on the Hong Kong Stock Exchange. The Shanghai-based drug developer is working to get Ascendis’ FDA-approved pediatric growth hormone deficiency drug greenlit in China. Sequentia Biotech raises €10M: The Spanish bioinformatics company nabbed the Series A from Seventure Partners and EIC Fund.

IPODrug ApprovalADC

100 Deals associated with JSKN-003

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HER2-Low Breast Carcinoma	Phase 3	CN	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	14 Nov 2023
Advanced Malignant Solid Neoplasm	Phase 2	CN	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	02 Mar 2023
Metastatic Solid Tumor	Phase 1	AU	Alphamab Australia Co. Pty Ltd.	02 Sep 2022
HER2 Positive Solid Tumors	IND Approval	CN	Jiangsu Alphamab Biopharmaceuticals Co., Ltd	13 Nov 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05494918 \| NCT05744427 (JSKN003-102, NEWS) Manual	Phase 1/2	Ovarian Cancer	50	JSKN003	(mlowwhwqph) = agdagnebdu ttywwuzkvq (dceluhxcca ) View more	Positive	17 Sep 2024
NCT05494918 \| NCT05744427 (JSKN003-102, NEWS) Manual	Phase 1/2	HER2 Positive Solid Tumors	29	JSKN003	(sshiubfmmu) = nekwkvnmmq oamgycpduj (mxjqhtliha ) View more	Positive	17 Sep 2024
NCT05494918 \| NCT05744427 (JSKN003-102, ESMO2024) Manual	Phase 1/2	Platinum-Resistant Ovarian Carcinoma	27	JSKN003	(pcczddkqxe) = ipsxnzvuim oiqowxcisj (edtiwbrjlm ) View more	Positive	14 Sep 2024
NCT05494918 \| NCT05744427 (JSKN003-102, ESMO2024) Manual	Phase 1/2	Platinum-Resistant Ovarian Carcinoma	27	JSKN003 (HER2 IHC 1+、2+ 和 3+)	(bjleatexae) = wpvmxcxevw xsvyseagmr (fkgliiqpqk )	Positive	14 Sep 2024
NCT05494918 \| NCT05744427 (JSKN003-102, ESMO2024) Manual	Phase 1/2	HER2 Positive Solid Tumors	24	JSKN003	(ksjlvlwcfj) = wbbvknkcty vnmepishyl (qmmemoomls ) View more	Positive	14 Sep 2024
NCT05744427 (JSKN003-102, NEWS) Manual	Phase 1/2	Solid tumor	46	JSKN003	(acratyrefm) = ciakxqzlny nuoranzswi (sustmjpfel, 35.8 - 66.3) View more	Positive	04 Jun 2024
NCT05744427 (JSKN003-102, ASCO2024)	Phase 1/2	Advanced Malignant Solid Neoplasm HER2-expressing \| HER2-mutant	46	JSKN003 2.1 mg/kg	rgjkrrphsk(mkdxxksgza) = No pts experienced DLT or interstitial lung disease, and no TRAE led to death or discontinuation yunqumibpb (btgmfjiywj ) View more	Positive	24 May 2024
NCT05744427 (JSKN003-102, ASCO2024)	Phase 1/2		46	JSKN003 4.2 mg/kg		Positive	24 May 2024
NCT05494918 (JSKN003-101, AACR2024) Manual	Phase 1	Solid tumor \|	32	JSKN003	(ybxvxeqeqz) = not been reached. twznmnouaz (eqreyttgmm ) View more	Positive	05 Apr 2024
NCT05494918 (JSKN003-101, Corporate Publications) Manual	Phase 1	HER2-Expressing Cancers	32	JSKN003	(vphcwoatma) = zftkiotmxx kkizrzpsdy (tsxpntpkkp ) View more	Positive	16 Nov 2023

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