Delving into the Latest Updates on BY101298 with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

AMO-959, BY 101298, BY 1298

+ [4]

Target

PRKDC

Action

inhibitors

Mechanism

PRKDC inhibitors(DNA-dependent protein kinase inhibitors)

Therapeutic Areas

NeoplasmsUrogenital DiseasesDigestive System Disorders

Active Indication

PSMA-Positive Castration-Resistant Prostatic CancerPrimary Malignant Liver Neoplasm

Inactive Indication

Advanced Malignant Solid NeoplasmBrain metastasesLocally Advanced Malignant Solid Neoplasm

Originator Organization

Chengdu Baiyu Pharmaceutical Co. Ltd.

Active Organization

Novartis Pharmaceuticals Corp.China Novartis Institutes for BioMedical Research Co., Ltd.

Chengdu Baiyu Pharmaceutical Co. Ltd.

+ [1]

Inactive Organization

Chengdu Baiyu Jingelai Pharmaceutical Co., Ltd.

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

Login to view timeline

The purpose of this phase Ib/II study is to (a) in Phase Ib evaluate the safety, tolerability, and pharmacokinetics (PK) of AMO959 when given in combination with lutetium (177Lu) vipivotide tetraxetan (also known as [177Lu]Lu-PSMA-617 or 177Lu-PSMA-617 and hereafter referred to as AAA617) with an androgen receptor pathway inhibitor (ARPI) in participants with metastatic castration resistant prostate cancer (mCRPC) who have failed one prior ARPI and with or without prior taxane exposure, and (b) in Phase II evaluate the preliminary efficacy of AMO959 in combination with AAA617 and ARPI in participants with mCRPC who have failed one prior ARPI, but who have not yet been exposed to taxane treatment.

Start Date16 Dec 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

CTR20240701

/ TerminatedPhase 1/2

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

[Translation] A Phase Ib/II clinical study to evaluate the safety, tolerability, efficacy and pharmacokinetic characteristics of BY101298 combined with radiotherapy in patients with malignant solid tumors

评价BY101298联合放疗在恶性实体瘤患者中的安全性、耐受性；确定BY101298联合放疗在恶性实体瘤患者中的Ⅱ期推荐剂量；评价BY101298联合放疗在恶性实体瘤患者中的初步疗效；

[Translation]

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.

100 Clinical Results associated with BY101298

Login to view more data

100 Translational Medicine associated with BY101298

Login to view more data

100 Patents (Medical) associated with BY101298

Login to view more data

100 Deals associated with BY101298

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
PSMA-Positive Castration-Resistant Prostatic Cancer	Phase 2	Australia	Novartis Pharmaceuticals Corp.	16 Dec 2025
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