Delving into the Latest Updates on SMET-12 with Synapse

Overview

Basic Info

Drug Type

Bispecific T-cell Engager (BiTE)

Synonyms

SMET 12, SMET-12, SMET12

Target

CD3 x EGFR

Action

stimulants, antagonists

Mechanism

CD3 stimulants(T cell surface glycoprotein CD3 stimulants), EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

Non-Small Cell Lung CancerEGFR positive Neoplasms

Inactive Indication-

Originator Organization

Zhejiang Shimai Pharmaceutical Co., Ltd.

Active Organization

Zhejiang Shimai Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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剂量递增阶段主要目的：评估SMET12在EGFR阳性晚期实体瘤患者中的安全性和耐受性；次要目的：确定SMET12在EGFR阳性晚期实体瘤患者中的剂量限制性毒性（DLT）和最大耐受剂量（MTD）；评估SMET12在EGFR阳性晚期实体瘤患者中的药代动力学（PK）特征；评估SMET12在EGFR阳性晚期实体瘤患者中的药效动力学（PD）特征；评估SMET12在EGFR阳性晚期实体瘤患者中的免疫原性。剂量扩展阶段主要目的：评估SMET12在EGFR阳性目标适应症患者中的抗肿瘤活性。次要目的：评估SMET12在EGFR阳性目标适应症患者中的安全性和耐受性；探索SMET12对免疫微环境的影响。

[Translation]

Dose-Escalation Phase Primary Objectives: Evaluate the safety and tolerability of SMET12 in patients with EGFR-positive advanced solid tumors. Secondary Objectives: Determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of SMET12 in patients with EGFR-positive advanced solid tumors. Evaluate the pharmacokinetic (PK) characteristics of SMET12 in patients with EGFR-positive advanced solid tumors. Evaluate the pharmacodynamic (PD) characteristics of SMET12 in patients with EGFR-positive advanced solid tumors. Evaluate the immunogenicity of SMET12 in patients with EGFR-positive advanced solid tumors. Dose-Expansion Phase Primary Objectives: Evaluate the anti-tumor activity of SMET12 in patients with EGFR-positive target indications. Secondary Objectives: Evaluate the safety and tolerability of SMET12 in patients with EGFR-positive target indications. Explore the effects of SMET12 on the immune microenvironment.

Start Date22 Sep 2025

Sponsor / Collaborator

Zhejiang Shimai Pharmaceutical Co., Ltd.

ChiCTR2500111540

/ RecruitingPhase 1/2IIT

An Open-label, Phase I/IIa Clinical Study of the Pharmacokinetics and Safety of SMET12 in Patients with Advanced Solid Tumors with Positive Epidermal Growth Factor Receptor (EGFR) Expression

Start Date03 Sep 2025

Sponsor / Collaborator

Fujian Cancer Hospital

[+2]

ChiCTR2400083057

/ RecruitingEarly Phase 1IIT

A single arm, cohort clinical study project to evaluate the efficacy and safety of SMET12 and Treprizumab combined chemotherapy in solid tumor patients with EGFR protein expression positive after systemic treatment failure

Start Date10 Apr 2024

Sponsor / Collaborator

Fujian Cancer Hospital

[+2]

100 Clinical Results associated with SMET-12

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100 Translational Medicine associated with SMET-12

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100 Patents (Medical) associated with SMET-12

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100 Deals associated with SMET-12

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR positive Neoplasms	Phase 2	China	Zhejiang Shimai Pharmaceutical Co., Ltd.	16 Jun 2023
Non-Small Cell Lung Cancer	Phase 2	China	Zhejiang Shimai Pharmaceutical Co., Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06208033 (SMET12, ASCO2025)	Early Phase 1	Advanced Lung Non-Small Cell Carcinoma First line EGFR protein-expressing \| EGFR mutation-positive	31	SMET12 + Toripalimab + Chemotherapy	nkogqvxxls(gmzbbunzxk) = prmezkmfxr kimowaiaeb (qwarrzpykj ) View more	Positive	30 May 2025
				SMET12 (Cohort A: Treatment-naïve subjects)	nkogqvxxls(gmzbbunzxk) = ihailgkuer kimowaiaeb (qwarrzpykj ) View more

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Translational Medicine

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Approval

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Biosimilar

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