Delving into the Latest Updates on Beta Pharma (Suzou) Co., Ltd. with Synapse

Overview

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Respiratory Diseases

Neoplasms

Skin and Musculoskeletal Diseases

Small molecule drug

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Technology Platform

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Disease Domain	Count

Neoplasms	1

Top 5 Drug Type	Count

Small molecule drug	1

Top 5 Target	Count

CDK4 x CDK6	1

[Translation] A Phase I clinical study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of BPI-1178 capsules in patients with advanced solid tumors, and a Phase IIa clinical study to evaluate the efficacy and safety of combined endocrine therapy in patients with HR+/HER2- advanced/recurrent breast cancer

I期研究主要评估BPI-1178单次及多次口服给药在晚期实体瘤患者中的耐受性和安全性及其药代动力学特征；并初步考察其对晚期实体瘤的疗效、初步进行血浆代谢产物的鉴定。IIa期研究主要评估BPI-1178联合内分泌治疗在HR+/HER2-的晚期乳腺癌患者中的疗效和安全性。如数据允许，初步考察BPI-1178及其代谢产物（如适用）的暴露-效应关系。

[Translation]

The Phase I study mainly evaluates the tolerability and safety of BPI-1178 in patients with advanced solid tumors after single and multiple oral administrations and its pharmacokinetic characteristics; and preliminarily investigates its efficacy in advanced solid tumors and preliminarily identifies plasma metabolites. The Phase IIa study mainly evaluates the efficacy and safety of BPI-1178 combined with endocrine therapy in patients with HR+/HER2- advanced breast cancer. If data permit, the exposure-effect relationship of BPI-1178 and its metabolites (if applicable) will be preliminarily investigated.

Start Date15 Jun 2020

Sponsor / Collaborator

Beta Pharma (Suzou) Co., Ltd.

NCT04282031

/ RecruitingPhase 1/2

A Phase 1/2a Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Efficacy of BPI-1178 Alone in Advanced Solid Tumor and of BPI-1178 in Combination With Endocrine Therapy in Advanced HR+/HER2- Breast Cancer

BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4（CDK4）and CDK6 kinase activity. This Phase I study is a first-in-human (FIH) clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of oral BPI-1178 in patients with advanced solid tumors. The Phase IIa trial is designed to investigate the anti-tumor activity and safety of BPI-1178 in combination with endocrine therapy in patients with HR+/HER2-advanced breast cancer and to determine the dosing regimen for combination with endocrine therapy in a later confirmatory study.

Start Date15 Jun 2020

Sponsor / Collaborator

Beta Pharma (Suzou) Co., Ltd.

100 Clinical Results associated with Beta Pharma (Suzou) Co., Ltd.

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0 Patents (Medical) associated with Beta Pharma (Suzou) Co., Ltd.

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100 Deals associated with Beta Pharma (Suzou) Co., Ltd.

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100 Translational Medicine associated with Beta Pharma (Suzou) Co., Ltd.

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Pipeline

Pipeline Snapshot as of 05 Feb 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Phase 2 Clinical

1

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