Delving into the Latest Updates on KY-0118 with Synapse

Overview

Basic Info

Drug Type

Biological products

Synonyms-

Target

IL-2R x PD-1

Mechanism

IL-2R modulators(Interleukin-2 receptor modulators), PD-1 modulators(Programmed cell death protein 1 modulators)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [3]

Active Indication

Locally Advanced Malignant Solid NeoplasmColorectal CancerMelanoma+ [5]

Inactive Indication-

Originator Organization

Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

Active Organization

Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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主要目的：评价KY-0118注射液用于局部晚期或转移性实体瘤患者的安全性和耐受性，确定剂量限制性毒性的及最大耐受剂量，确定后期临床试验推荐剂量，并为后期临床试验制定给药方案提供依据。次要目的：1.评价KY-0118注射剂在局部晚期或转移性实体瘤患者中的药代动力学、药效动力学特征和免疫原性；2.初步评价KY-0118注射剂治疗局部晚期或转移性实体瘤的抗肿瘤疗效。

[Translation]

Primary objectives: To evaluate the safety and tolerability of KY-0118 injection in patients with locally advanced or metastatic solid tumors, determine the dose-limiting toxicity and the maximum tolerated dose, determine the recommended dose for later clinical trials, and provide a basis for the formulation of dosing regimens for later clinical trials. Secondary objectives: 1. To evaluate the pharmacokinetics, pharmacodynamic characteristics and immunogenicity of KY-0118 injection in patients with locally advanced or metastatic solid tumors; 2. To preliminarily evaluate the anti-tumor efficacy of KY-0118 injection in the treatment of locally advanced or metastatic solid tumors.

Start Date20 Dec 2022

Sponsor / Collaborator

Novatim Immune Therapeutics (Zhejiang) Co., Ltd.

100 Clinical Results associated with KY-0118

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100 Translational Medicine associated with KY-0118

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100 Patents (Medical) associated with KY-0118

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100 Deals associated with KY-0118

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Malignant Solid Neoplasm	Phase 1	CN	Novatim Immune Therapeutics (Zhejiang) Co., Ltd.	28 Dec 2022
Colorectal Cancer	Phase 1	CN	Novatim Immune Therapeutics (Zhejiang) Co., Ltd.	20 Dec 2022
Melanoma	Phase 1	CN	Novatim Immune Therapeutics (Zhejiang) Co., Ltd.	20 Dec 2022
Non-Small Cell Lung Cancer	Phase 1	CN	Novatim Immune Therapeutics (Zhejiang) Co., Ltd.	20 Dec 2022
Pancreatic Cancer	Phase 1	CN	Novatim Immune Therapeutics (Zhejiang) Co., Ltd.	20 Dec 2022
Renal Cell Carcinoma	Phase 1	CN	Novatim Immune Therapeutics (Zhejiang) Co., Ltd.	20 Dec 2022
Transitional Cell Carcinoma	Phase 1	CN	Novatim Immune Therapeutics (Zhejiang) Co., Ltd.	20 Dec 2022
Metastatic Solid Tumor	IND Approval	CN	Novatim Immune Therapeutics (Zhejiang) Co., Ltd.	27 Jun 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06175780 (ASCO2024) Manual	Phase 1	Locally Advanced Clear Cell Renal Cell Carcinoma \| Melanoma \| Transitional Cell Carcinoma	21	KY-0118	ajjgxtcwif(ufiseshgza) = Most of TEAEs are transient grade 1-2, no TEAE led to withdrawal from this study zxjfclixiy (kepjuoepun ) View more	Positive	24 May 2024