Delving into the Latest Updates on BY101298 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

BY 101298, BY 1298, BY-101298

+ [3]

Target

PRKDC

Action

inhibitors

Mechanism

PRKDC inhibitors(DNA-dependent protein kinase inhibitors)

Therapeutic Areas

NeoplasmsDigestive System Disorders

Active Indication

Primary Malignant Liver Neoplasm

Inactive Indication

Advanced Malignant Solid NeoplasmBrain metastasesLocally Advanced Malignant Solid Neoplasm

Originator Organization

Chengdu Baiyu Pharmaceutical Co. Ltd.

Active Organization

Chengdu Baiyu Pharmaceutical Co. Ltd.

Inactive Organization

Chengdu Baiyu Jingelai Pharmaceutical Co., Ltd.

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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To evaluate the safety and tolerability of BY101298 combined with radiotherapy in patients with malignant solid tumors; to determine the recommended Phase II dose of BY101298 combined with radiotherapy in patients with malignant solid tumors; to evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients with malignant solid tumors;

Start Date19 Jul 2024

Sponsor / Collaborator

Chengdu Baiyu Pharmaceutical Co. Ltd.

[+1]

NCT06524804

/ TerminatedPhase 1/2

A Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of BY101298 Combined with Radiotherapy in Patients with Malignant Solid Tumors

BY101298 is an innovative DNA-dependent protein kinases (DNA-PK) highly selective small molecule inhibitor. DNA-dependent protein kinases (DNA-PK plays a key role in the NHEJ repair pathway to repair DNA double-strand breaks (DSBs). By inhibiting DNA-PK activity to inhibit DSBs repair, BY101298 may synergistically improve the killing effect on tumor cells, reduce the risk of local recurrence and metastasis, and improve the clinical benefit of cancer patients when combing with radiotherapy.
Primary objective is to assess the safety and tolerability; RP2D. The secondary Objectives are to characterize the pharmacokinetic (PK) profile of BY101298 and to assess the preliminary efficacy.

Start Date15 May 2024

Sponsor / Collaborator

Chengdu Baiyu Pharmaceutical Co. Ltd.

CTR20230997

/ Active, not recruitingPhase 1

一项评估BY101298单药/联合放疗在恶性实体瘤患者中的安全性、耐受性、药代动力学特征的Ⅰ期临床研究

[Translation] A Phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of BY101298 alone or in combination with radiotherapy in patients with malignant solid tumors

Ia期：主要目的：评价BY101298在晚期恶性实体瘤患者中的安全性、耐受性。次要目的：评价BY101298在晚期恶性实体瘤患者中的药代动力学(PK)特征; 初步探索BY101298在晚期恶性实体瘤患者中的有效性。 Ib期：主要目的：评价BY101298联合放疗在恶性实体瘤患者中的安全性、耐受性。次要目的：初步探索BY101298联合放疗在恶性实体瘤患者中的有效性; 评价BY101298联合放疗在恶性实体瘤患者中的药代动力学(PK)特征。

[Translation]

Phase Ia: Primary purpose: To evaluate the safety and tolerability of BY101298 in patients with advanced malignant solid tumors. Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of BY101298 in patients with advanced malignant solid tumors; To preliminarily explore the effectiveness of BY101298 in patients with advanced malignant solid tumors. Phase Ib: Primary purpose: To evaluate the safety and tolerability of BY101298 combined with radiotherapy in patients with malignant solid tumors. Secondary purpose: To preliminarily explore the effectiveness of BY101298 combined with radiotherapy in patients with malignant solid tumors; To evaluate the pharmacokinetic (PK) characteristics of BY101298 combined with radiotherapy in patients with malignant solid tumors.

Start Date25 Apr 2023

Sponsor / Collaborator

Chengdu Baiyu Pharmaceutical Co. Ltd.

100 Clinical Results associated with BY101298

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100 Translational Medicine associated with BY101298

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100 Patents (Medical) associated with BY101298

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100 Deals associated with BY101298

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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 2	China	Chengdu Baiyu Jingelai Pharmaceutical Co., Ltd.	19 Jul 2024
Advanced Malignant Solid Neoplasm	Phase 2	China	Chengdu Baiyu Pharmaceutical Co. Ltd.	19 Jul 2024
Brain metastases	Phase 2	China	Chengdu Baiyu Pharmaceutical Co. Ltd.	15 May 2024
Locally Advanced Malignant Solid Neoplasm	Phase 2	China	Chengdu Baiyu Pharmaceutical Co. Ltd.	15 May 2024
Primary Malignant Liver Neoplasm	Phase 1	China	Chengdu Baiyu Pharmaceutical Co. Ltd.	25 Apr 2023