[Translation] An open-label, multicenter, phase 2 study to evaluate the efficacy, safety, and pharmacokinetics (PK) of belintozumab in Chinese pediatric subjects with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL)

主要目的：评价贝林妥欧单抗的有效性；次要目的：评价贝林妥欧单抗的安全性和耐受性；评价贝林妥欧单抗的药代动力学（PK）；评价贝林妥欧单抗治疗后的总生存期（OS）；评价贝林妥欧单抗治疗后的无复发生存期；评估alloHSCT的使用和alloHSCT使用后的100天死亡率；评价贝林妥欧单抗的免疫原性；评价微小残留病（MRD）。

[Translation]

Primary objective: To evaluate the efficacy of belintoumab; Secondary objectives: To evaluate the safety and tolerability of belintoumab; To evaluate the pharmacokinetics (PK) of belintoumab; To evaluate the overall survival (OS) after belintoumab treatment; To evaluate the relapse-free survival after belintoumab treatment; To evaluate the use of alloHSCT and the 100-day mortality after alloHSCT use; To evaluate the immunogenicity of belintoumab; To evaluate minimal residual disease (MRD).

Start Date11 Jul 2024

Sponsor / Collaborator

Amgen, Inc.

[+3]

CTR20241523

/ RecruitingPhase 3

一项在铂类药物、依托泊苷和度伐利尤单抗治疗后广泛期小细胞肺癌受试者中比较Tarlatamab 联合度伐利尤单抗与度伐利尤单抗单药治疗的开放性、多中心、随机、3 期研究（DeLLphi-305）

[Translation] An open-label, multicenter, randomized, phase 3 study comparing tarlatamab plus durvalumab versus durvalumab alone in subjects with extensive-stage small cell lung cancer after treatment with platinum-based therapy, etoposide, and durvalumab (DeLLphi-305)

这是一项在完成铂类药物化疗（研究者所选治疗：卡铂或顺铂）、依托泊苷和度伐利尤单抗一线治疗后根据RECIST 1.1 确定持续缓解或疾病稳定的ES-SCLC 受试者中评价tarlatamab +度伐利尤单抗与度伐利尤单抗单药治疗相比的有效性和安全性的随机、开放性、多中心3 期研究。

[Translation]

This was a randomized, open-label, multicenter, phase 3 study evaluating the efficacy and safety of tarlatamab plus durvalumab compared with durvalumab alone in subjects with ES-SCLC who had a sustained response or stable disease according to RECIST 1.1 after completing first-line treatment with platinum-based chemotherapy (investigator's choice of treatment: carboplatin or cisplatin), etoposide, and durvalumab.

Start Date03 Jun 2024

Sponsor / Collaborator

Amgen, Inc.

[+1]

CTR20234106

/ RecruitingPhase 1

一项评价AMG 509用于转移性去势抵抗性前列腺癌受试者的安全性、耐受性、药代动力学和有效性的1期研究

[Translation] A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects with Metastatic Castration-Resistant Prostate Cancer

在成人受试者中评价AMG 509 治疗的安全性和耐受性，确定AMG 509 治疗的最大耐受剂量（MTD）或2期推荐剂量（RP2D），表征AMG 509 治疗的药代动力学（PK）特征，初步评价AMG 509 治疗的抗肿瘤活性。

[Translation]

To evaluate the safety and tolerability of AMG 509 treatment in adult subjects, determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 509 treatment, characterize the pharmacokinetic (PK) characteristics of AMG 509 treatment, and preliminarily evaluate the anti-tumor activity of AMG 509 treatment.

Start Date02 Apr 2024

Sponsor / Collaborator

Amgen, Inc.

[+1]

100 Clinical Results associated with BeiGene (Beijing) Co. Ltd.

0 Patents (Medical) associated with BeiGene (Beijing) Co. Ltd.

240

Literatures (Medical) associated with BeiGene (Beijing) Co. Ltd.

25 Apr 2025·Cancer Research

Abstract CT193: Trial in progress: A first-in-human phase 1a/b study of BGB-58067, an MTA-cooperative PRMT5 inhibitor, in patients with advanced solid tumors and MTAP deficiency

Author: Chuwueke, Ugonma ; Gan, Hui ; Humphries, Timothy ; Van Tine, Brian A. ; Huang, Hayden ; Postel-Vinay, Sophie ; Dong, Yan ; Zhou, Caicun ; Wang, Chunyu ; Qin, Tai

AbstractBackground:Protein arginine methyltransferase 5 (PRMT5) is an enzyme that methylates substrates involved in cellular activities, including transcription, RNA splicing, DNA damage repair, apoptosis, and cell-cycle regulation, and may act as an oncogene in multiple tumor types. Overexpression of PRMT5 is associated with poor clinical outcomes in a variety of cancers, including lung, colon, pancreas, and bladder cancer, and glioblastoma multiforme. Homozygous loss of the methylthioadenosine phosphorylase (MTAP) gene occurs in 15% of all tumor types, leading to the accumulation of methylthioadenosine (MTA), which partially inhibits PRMT5 and increases the susceptibility of these tumor cells to additional PRMT5 inhibition. BGB-58067 is an oral, highly potent, brain-penetrant, MTA-cooperative PRMT5 inhibitor that selectively inhibits PRMT5 in tumors with MTAP deletion. Preclinical evidence has shown the effectiveness of BGB-58067 in inhibiting PRMT5-mediated signaling and in its in vivo antitumor activity.Methods:This study is a first-in-human, phase 1a/b, open-label, international, multicenter trial to evaluate the safety/tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BGB-58067 in patients with advanced solid tumors with MTAP deficiency (NCT06589596). In the dose-escalation and safety-expansion phase (phase 1a), sequential cohorts of patients will receive increasing dose levels of BGB-58067 given orally as monotherapy. In the dose-expansion and optimization phase (phase 1b), patients with select tumor types will receive BGB-58067 at the recommended dose(s) for expansion (RDFE[s]). Eligible patients are ≥18 years of age with pathologically confirmed advanced, metastatic, or unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available or tolerated and with evidence of homozygous loss of the MTAP gene or lost MTAP expression in the tumor tissue. For phase 1a, the primary objectives are to assess the safety/tolerability of BGB-58067 and to determine the maximum tolerated dose or maximum administered dose and RDFE(s); secondary objectives are to assess the preliminary antitumor activity (objective response rate [ORR], duration of response [DOR], and disease control rate [DCR], per investigator) and PK of BGB-58067. For phase 1b, the primary objectives are to determine the recommended phase 2 dose and to assess the antitumor activity (ORR per investigator); secondary objectives are to further assess antitumor activity (DOR, DCR and progression-free survival per investigator) and safety/tolerability of BGB-58067. As of December 2024, the trial is actively recruiting patients in Australia, China, and the United States.Citation Format:Brian A. Van Tine, Timothy Humphries, Sophie Postel-Vinay, Hui Gan, Ugonma Chuwueke, Tai Qin, Hayden Huang, Chunyu Wang, Yan Dong, Caicun Zhou. Trial in progress: A first-in-human phase 1a/b study of BGB-58067, an MTA-cooperative PRMT5 inhibitor, in patients with advanced solid tumors and MTAP deficiency [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT193.

22 Apr 2025·Blood Advances

Acquired mutations in patients with relapsed/refractory CLL who progressed in the ALPINE study

Article

Author: Cohen, Aileen Cleary ; Huang, Ruiqi ; Eichhorst, Barbara F. ; Shadman, Mazyar ; Idoine, Adam ; O’Brien, Susan M. ; Shi, Yang ; Li, Jessica ; Salmi, Tommi ; Lamanna, Nicole ; Brown, Jennifer R. ; Tam, Constantine S. ; Qiu, Lugui

AbstractSome patients with chronic lymphocytic leukemia who develop progressive disease (PD) during covalent Bruton tyrosine kinase (BTK) inhibitor treatment acquire resistance mutations in BTK or PLCG2. Here, we report gene mutation data from paired baseline and PD peripheral blood samples from 52 patients (zanubrutinib, n = 24; ibrutinib, n = 28) who, at an early median follow-up of 25.7 months, progressed on zanubrutinib or ibrutinib treatment in ALPINE. No BTK mutations were observed at baseline; at PD, 8 patients (zanubrutinib, n = 5; ibrutinib, n = 3) acquired 17 BTK mutations, 82.4% (zanubrutinib, n = 11/14; ibrutinib, n = 3/3) at C481. Non-C481 mutations occurred in 12.5% (3/24) of zanubrutinib-treated patients (L528W: n = 2; cancer cell fraction [CCF] = 9.58% and 17.6%; A428D: n = 1; CCF = 37.03%). At baseline, 48 of 52 patients had ≥1 driver gene mutation(s), most frequently in NOTCH1 (n = 21), TP53 (n = 19), BRAF (n = 10), SF3B1 (n = 8), and ATM (n = 8). At PD, acquired mutations occurred in 1 zanubrutinib-treated patient (TP53, XPO1) and 5 ibrutinib-treated patients (TP53, n = 1 patient; SETD2, n = 1; SF3B1, n = 1; ASXL1, n = 2). Baseline driver gene mutations were not associated with development of BTK mutations, but patients with ≥2 baseline driver gene mutations were more likely to acquire BTK mutations at PD. The short treatment duration and a low BTK mutations incidence suggests that mechanisms other than BTK/PLCG2 mutations drive most early PD. This trial was registered at www.ClinicalTrials.gov as #NCT03734016.

21 Apr 2025·Cancer Research

Abstract 2232: BGB-R046, an IL-15 pro-drug demonstrates robust pharmacodynamic effects and immune activation within tumor microenvironment in a mouse syngeneic model

Author: Luo, Li ; Hu, Huixia ; Wu, Yue ; Kong, Qinyi ; Chen, Xin ; Shen, Zhirong ; Zhang, Amin ; Jin, Wei ; Deng, Minjuan ; Liu, Silu ; Jiang, Yu ; Li, Xiaoyu ; Li, Feihong ; Luan, Xudong ; Wang, Mengjia

AbstractBackground:Interleukin-15 (IL-15) is crucial for the proliferation and survival of NK and memory T cells, and has great potential in cancer immunotherapy. Rapid plasma clearance of conventional IL-15 and therefore insufficient tumor exposure and immune activation pose a significant limitation in its development as an immuno-oncology therapeutics. BGB-R046 is developed as an IL-15 pro-drug, which masks free drug release in circulation and is activated in tumors by utilizing tumor enriched proteases to release active IL-15Rα-sushi-IL-15, an IL-15 super-agonist(SITC#950). BGB-R046 induced pharmacodynamic effects and immune activation was evaluated in this study, in immune competent mice bearing syngeneic tumor model, to study its pharmacodynamic effects in both circulation and tumor.Method:Anti-tumor efficacy was evaluated in the MC38 syngeneic model in IL-15 and IL-15 receptors humanized mice. Active IL-15 released from pro-drug induced downstream signaling events were evaluated in human primary CD8+T and NK cells. The pharmacokinetics (PK) and pharmacodynamic(PD) biomarkers were evaluated in humanized IL-15/IL-15 receptor mice bearing MC38 syngeneic tumor after BGB-R046 administration.Results:BGB-R046 exhibits protease dependent activation and shows significant anti-tumor efficacy in MC38 syngeneic model. Active pro-IL-15 robustly engages the IL-15 pathway, demonstrated by STAT5 phosphorylation and CD122 downregulation in vitro, which are two target engagement PD markers induced by IL-15. Following BGB-R046 administration in vivo, minimum active drug release was detected in the circulation while active drug release was more sustained in tumor. Consistently, STAT5 phosphorylation was significantly increased in tumor, while undetectable in circulation on day 7 after BGB-R046 treatment. In addition, surface CD122 level on NK cells was downregulated in tumor while maintained in the circulation, suggesting robust IL-15R target engagement within tumor microenvironment by pro-drug design. Accordingly, BGB-R046 treatment induced significant immune activation in tumor, demonstrated by CD8+ T and NK cell proliferation and activation, consistent with its robust anti-tumor activity in this model.Conclusions:BGB-R046 is an IL-15 prodrug with minimum free drug release in the peripheral and induced robust pharmacodynamic effects and immune activation within tumor microenvironment in the MC38 mouse syngeneic model. A clinical study evaluating BGB-R046 as monotherapy and in combination with tislelizumab (anti-PD-1 antibody) in patients with advanced or metastatic tumors is ongoing(NCT06487858).Citation Format:Yu Jiang, Amin Zhang, Minjuan Deng, Feihong Li, Qinyi Kong, Silu Liu, Xiaoyu Li, Li Luo, Yue Wu, Mengjia Wang, Xudong Luan, Huixia Hu, Xin Chen, Wei Jin, Zhirong Shen. BGB-R046, an IL-15 pro-drug demonstrates robust pharmacodynamic effects and immune activation within tumor microenvironment in a mouse syngeneic model [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 2232.

100 Deals associated with BeiGene (Beijing) Co. Ltd.

100 Translational Medicine associated with BeiGene (Beijing) Co. Ltd.

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Pipeline Snapshot as of 16 May 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

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Drug(Targets)	Indications	Global Highest Phase

Pamiparib ( PARP1 x PARP2 )	Recurrent ovarian cancer More	Phase 3
TARLATAMAB-DLLE	Extensive stage Small Cell Lung Cancer More	Phase 3
Albumin-Bound Paclitaxel ( Tubulin )	Squamous non-small cell lung cancer More	Phase 3
Zanidatamab ( HER2 )	HER2 Positive Gastroesophageal Adenocarcinoma More	Phase 3
Blinatumomab ( CD19 x CD3 )	Pre B-cell acute lymphoblastic leukemia More	Phase 2

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