Delving into the Latest Updates on IAH-0968 with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

IAH0968

Target

HER2

Action

modulators

Mechanism

HER2 modulators(Receptor tyrosine-protein kinase erbB-2 modulators)

Therapeutic Areas

NeoplasmsDigestive System DisordersSkin and Musculoskeletal Diseases+ [1]

Active Indication

Advanced Malignant Solid NeoplasmColorectal CancerGastroesophageal junction adenocarcinoma+ [12]

Inactive Indication-

Originator Organization

Sunho (China) Biopharmaceutical Co., Ltd.

Active Organization

Sunho (China) Biopharmaceutical Co., Ltd.

Beijing Sunho Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2/3

First Approval Date-

Regulation-

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The safety, tolerability, and determination of the maximum tolerated dose (MTD) of the combination therapy were first evaluated for IAH0968 in combination with or without the CAPEOX regimen in unsystematically treated subjects with HER2-expressing advanced/metastatic colorectal or gastric cancers (including adenocarcinomas of the gastro-esophageal junction) or HER2-hypo-expressing advanced/metastatic solid tumors. The efficacy of IAH0968 in combination with the CAPEOX regimen versus trastuzumab in combination with the CAPEOX regimen in subjects with HER2-positive advanced/metastatic gastric cancer, including gastro-esophageal junction adenocarcinoma, was then assessed by progression-free survival (PFS) according to the Research and Evaluation Criteria for the Evaluation of Efficacy in Solid Tumors (RECIST) 1.1.

Start Date15 Aug 2024

Sponsor / Collaborator

Sunho (China) Biopharmaceutical Co., Ltd.

CTR20223087

/ RecruitingPhase 1/2

IAH0968联合吉西他滨及顺铂治疗HER2阳性不可切除的晚期/转移性的恶性肿瘤和胆管癌的Ib/II期临床研究

[Translation] Phase Ib/II clinical study of IAH0968 combined with gemcitabine and cisplatin in the treatment of HER2-positive unresectable advanced/metastatic malignancies and cholangiocarcinoma

Ib 期研究：对于经标准治疗失败的成人 HER2 阳性晚期实体瘤患者，确定静脉滴注 IAH0968 联合 GC 方案的最大耐受剂量（ Maximaltolerable dose， MTD）、剂量限制毒性（Dose limited toxicity， DLT）和/或 II 期推荐剂量（RP2D）。 II 期研究：采用 Ib 期研究确定的 RP2D，一线用于未经系统治疗的HER2阳性晚期或转移性胆管癌（BTC）患者，依据实体瘤疗效评价标准（ RECIST） 1.1，通过客观缓解率（ Objective Remission Rate，ORR）对比 IAH0968 联合 GC 方案与安慰剂联合 GC 方案的有效性。

[Translation]

Phase Ib study: To determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT) and/or Phase II recommended dose (RP2D) of intravenous IAH0968 combined with GC for adult patients with HER2-positive advanced solid tumors who have failed standard treatment. Phase II study: Using the RP2D determined in the Phase Ib study, it is used as the first-line treatment for patients with HER2-positive advanced or metastatic cholangiocarcinoma (BTC) who have not received systemic treatment. According to RECIST 1.1, the effectiveness of IAH0968 combined with GC and placebo combined with GC is compared by objective remission rate (ORR).

Start Date31 Jul 2023

Sponsor / Collaborator

Sunho (China) Biopharmaceutical Co., Ltd.

CTR20223453

/ RecruitingPhase 2

评估IAH0968联合CAPEOX方案用于HER2阳性的转移性结直肠癌的II/III期临床研究

[Translation] Phase II/III clinical study evaluating IAH0968 combined with CAPEOX regimen for HER2-positive metastatic colorectal cancer

主要研究目的 IIa 期：评估 IAH0968 联合 CAPEOX 方案在 HER2 阳性晚期或转移性恶性实体瘤受试者中的安全性、耐受性，确定联合治疗的最大耐受剂量（MTD）和/或 II 期推荐剂量（RP2D）。 IIb 期：依据实体瘤疗效评价标准（RECIST）1.1，通过无进展生存期（PFS）评估 IAH0968 联合 CAPEOX 方案在 HER2 阳性转移性结直肠癌受试者中的有效性。 III 期：依据 RECIST 1.1，通过 PFS 评估 IAH0968 联合 CAPEOX 方案对比安慰剂联合 CAPEOX 方案在 HER2 阳性转移性结直肠癌受试者中的有效性。次要研究目的 IIa 期：评估 IAH0968 在联合 CAPEOX 方案时的药代动力学（PK）特征、免疫原性及联用方案的初步有效性。 IIb/III 期：评估 IAH0968 联合 CAPEOX 方案在 HER2 阳性转移性结直肠癌受试者中的安全性、耐受性及免疫原性。探索性研究目的探索 HER2 相关生物标志物与临床有效性间的关系

[Translation]

Main study objectives Phase IIa: To evaluate the safety and tolerability of IAH0968 combined with CAPEOX in subjects with HER2-positive advanced or metastatic malignant solid tumors, and to determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D) of the combined treatment. Phase IIb: According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, the effectiveness of IAH0968 combined with CAPEOX in subjects with HER2-positive metastatic colorectal cancer was evaluated by progression-free survival (PFS). Phase III: According to RECIST 1.1, the effectiveness of IAH0968 combined with CAPEOX was evaluated by PFS compared with placebo combined with CAPEOX in subjects with HER2-positive metastatic colorectal cancer. Secondary study objectives Phase IIa: To evaluate the pharmacokinetic (PK) characteristics, immunogenicity and preliminary effectiveness of the combination regimen of IAH0968 combined with CAPEOX. Phase IIb/III: To evaluate the safety, tolerability, and immunogenicity of IAH0968 combined with CAPEOX in subjects with HER2-positive metastatic colorectal cancer. Exploratory study objectives To explore the relationship between HER2-related biomarkers and clinical efficacy

Start Date12 May 2023

Sponsor / Collaborator

Sunho (China) Biopharmaceutical Co., Ltd.

100 Clinical Results associated with IAH-0968

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100 Translational Medicine associated with IAH-0968

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100 Patents (Medical) associated with IAH-0968

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1

Literatures (Medical) associated with IAH-0968

Frontiers in Immunology

A novel anti-HER2 monoclonal antibody IAH0968 in HER2-positive heavily pretreated solid tumors: results from a phase Ia/Ib first-in-human, open-label, single center study

Article

Author: Liu, Yang ; Yin, Liusong ; Xu, Tie ; Wang, Jin ; Cui, Jian ; Song, Na ; Yu, Ping ; Jin, Bo ; Jiang, Shujie ; Qu, Xiujuan ; Zhang, Lingyun ; Liu, Yunpeng ; Li, Aodi ; Teng, Zan ; Tong, Linlin ; Qu, Jinglei ; Teng, Yuee ; Jiang, Xiaoling ; Zhao, Lei ; Shi, Jing

Background:

IAH0968 is an afucosylated anti-epidermal growth factor receptor 2 (HER2) monoclonal antibody which improved the activity of antibody-dependent cellular cytotoxicity (ADCC) and superior anti-tumor efficacy.

Methods:

To determine the maximum tolerated dose (MTD) with dose-limiting toxicity (DLT), a single institution, phase Ia/Ib study was undertaken, using 3 + 3 design. The primary endpoints were safety, tolerability and preliminary clinical activity. Eighteen patients were evaluable for safety and fifteen patients were suitable for efficacy analysis. Dose escalations were 6 mg/kg (N = 2), 10 mg/kg (N = 7), 15 mg/kg (N = 5), and tolerable up to 20 mg/kg (N = 4).

Results:

Only one DLT was found at dosage 10 mg/kg, and no MTD was reached. The most common Grade 3 treatment-related adverse events (TRAEs) were hypokalemia (5.6%), supraventricular tachycardia (5.6%), interval extension of QTC (5.6%), and infusion reaction (5.6%). Grade 4 TRAE was arrhythmia (5.6%). No serious TRAE or Grade 5 was reported. 22.2% of patients had a TRAE leading to dose adjustment and 16.7% of patients had a TRAE resulting in discontinuation of IAH0968. After a median follow-up of 9.7 months (range, 3.7 - 22.0), the objective response rate (ORR) was 13.3% (2/15), the disease control rate (DCR) was 53.3% (8/15), and median progression-free survival (mPFS) was 4.2 months (95% CI: 1.4 - 7.7), and the median duration of disease control (DDC) was 6.3 months (95% CI: 2.9–not reached), with 4/15 responses ongoing.

Conclusions:

In HER2-positive heavily pretreated metastatic patients, IAH0968 demonstrated promising clinical activity with durable responses and tolerable safety profiles.

Clinical trial registration:

ClinicalTrials.gov, identifier NCT04934514.

100 Deals associated with IAH-0968

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 3	China	Sunho (China) Biopharmaceutical Co., Ltd.	15 Aug 2024
Colorectal Cancer	Phase 3	China	Sunho (China) Biopharmaceutical Co., Ltd.	15 Aug 2024
Gastroesophageal junction adenocarcinoma	Phase 3	China	Sunho (China) Biopharmaceutical Co., Ltd.	15 Aug 2024
Hepatocellular Carcinoma	Phase 3	China	Sunho (China) Biopharmaceutical Co., Ltd.	15 Aug 2024
Malignant neoplasm of gastro-oesophageal junction	Phase 3	China	Sunho (China) Biopharmaceutical Co., Ltd.	15 Aug 2024
Metastatic Gastric Carcinoma	Phase 3	China	Sunho (China) Biopharmaceutical Co., Ltd.	15 Aug 2024
Metastatic Solid Tumor	Phase 3	China	Sunho (China) Biopharmaceutical Co., Ltd.	15 Aug 2024
HER2 Positive Cancer	Phase 3	China	Sunho (China) Biopharmaceutical Co., Ltd.	19 Jul 2024
HER2-positive gastric cancer	Phase 3	China	Sunho (China) Biopharmaceutical Co., Ltd.	19 Jul 2024
HER2 Positive Colorectal Cancer	Phase 3	China	Beijing Sunho Pharmaceutical Co., Ltd.	12 May 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04934514 (phase Ia/Ib first-in-human, Pubmed \| Front Immunol)	Phase 1	HER2 Positive Solid Tumors HER2-positive	-	IAH0968 6 mg/kg	zmdmnpikgt(hmfsfplzlb) = 5.6% jeyfinkxad (vtzpupivsd ) View more	Positive	29 Nov 2024
	Phase 1	HER2 Positive Solid Tumors HER2-positive	-	IAH0968 10 mg/kg		Positive	29 Nov 2024
NCT04934514 (ASCO2023) Manual	Phase 1	HER2 Positive Solid Tumors HER2 Positive	18	IAH0968	qenragmrkw(fibhajlvgl) = okqxvpgfsi mtjoagaawl (msqreoouna ) View more	Positive	31 May 2023

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Biosimilar

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