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-

Login to view timeline

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

Login to view more data

100 Translational Medicine associated with KY-0118

Login to view more data

100 Patents (Medical) associated with KY-0118

Login to view more data

100 Deals associated with KY-0118

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

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

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

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	(gxbixwlmks) = Most of TEAEs are transient grade 1-2, no TEAE led to withdrawal from this study dctrsllnas (ylhrzdmyne ) View more	Positive	24 May 2024