A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors

This study will evaluate the safety, tolerability, and preliminary efficacy of EIK1004 (IMP1707) in participants with recurrent advanced/metastatic breast cancer, ovarian cancer, metastatic castrate resistant prostate cancer (mCRPC) and pancreatic cancer with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) genes.
Condition or disease Intervention/treatment Phase Advanced Solid Tumors Drug: EIK1004 (IMP1707) Phase 1/Phase 2

开始日期2025-04-01

申办/合作机构

Eikon Therapeutics, Inc.初创企业

[+1]

NCT06617923

/ Recruiting临床2期IIT

A Phase 2 Study of Senaparib in Combination With Temozolomide in ARID1A Mutation Associated Ovarian Cancer

This is a phase 2 study to test the effectiveness (anti-tumor activity) of the combination of the study drugs, Senaparib and Temozolomide, in patients with clear cell or endometrioid ovarian cancers that have ARID1A pathologic variants.

开始日期2025-02-06

申办/合作机构

The Sidney Kimmel Comprehensive Cancer Center

[+2]

CTR20240637

/ Recruiting临床1/2期

一项在晚期实体瘤患者中评价PARP1选择性抑制剂IMP1734的安全性、耐受性、药代动力学、药效学和抗肿瘤活性的开放性、多中心、首次人体的剂量递增、剂量优化和剂量扩展的Ⅰ/Ⅱ期研究

评价 IMP1734 的安全性和耐受性，确定最大耐受剂量（或最高可达剂量) 和推荐的扩展剂量（RDE），以及评估IMP1734 的抗肿瘤活性，评价IMP1734单次/多次给药后在晚期实体瘤患者中的药代动力学（PK）特征及有效性，评价IMP1734在晚期实体瘤患者中的药效学（PD）特征、疗效与生物标志物之间的关系、对QTc间期的影响、食物效应等

开始日期2024-03-13

申办/合作机构

上海瑛派药业有限公司初创企业

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项与南京英派药业有限公司相关的文献（医药）

2025-01-02·MOLECULAR CANCER THERAPEUTICS

The Discovery of a Potent PARP1 Inhibitor Senaparib

Article

作者: Guo, Mingchuan ; Cai, Sui X. ; Tian, Ye E. ; Jiang, Yangzhen ; Ma, Ning ; Wang, Xiaozhu

Abstract:

PARP1 is a critical enzyme involved in DNA damage repair. It belongs to a superfamily of proteins and catalyzes poly(ADP-ribosyl)ation (PARylation). PARP1 inhibitors are effective to treat tumors that have homologous recombination deficiency such as those with BRCA1/2 mutations. The PARP1 inhibitors that have been approved by FDA inhibit both PARP1 and PARP2. PARP2 has also been suggested to play a similar function in DNA repair as PARP1. In addition to inhibiting PARP1 enzymatic activities, PARP1 inhibitors cause the PARP1 enzyme to be “trapped” on DNA, stalling the DNA replication fork and eventually causing double-strand DNA breaks and cell death. Here, we report a PARP1 inhibitor, Senaparib, which has a novel chemical structure and high potency inhibiting PARP1/2 enzymes. Senaparib was highly potent in cell viability tests against tumor cells with BRCA1/2 mutations. It was efficacious in cell line-derived and patient-derived xenograft models in tumors harboring BRCA1/2 mutations. In combination studies, Senaparib used with temozolomide had shown strong synergistic cytotoxicity in both in vitro and in vivo experiments. Senaparib represents a novel class of PARP1 inhibitors that can be used for the treatment of cancer. A phase III clinical study of Senaparib for maintenance treatment following first-line chemotherapy in patients with advanced ovarian cancer has met its primary endpoint, and a new drug application of Senaparib has been accepted by the National Medical Products Administration of China for review.

2023-12-11·The oncologist

Safety, Tolerability, and Pharmacokinetics of Senaparib, a Novel PARP1/2 Inhibitor, in Chinese Patients With Advanced Solid Tumors: A Phase I Trial

Article

作者: Edward Tian, Ye ; Xiong Cai, Sui ; Ji, Dongmei ; Xu, Cong ; Zhang, Pin ; Zhang, Shun ; Hsieh, Chih-Yi ; Cao, Junning ; Shen, Weina ; Guo, Hongqian ; Xu, Binghe

Abstract:

Background:

Senaparib, a novel poly(ADP-ribose) polymerase 1/2 inhibitor, demonstrated antitumor activity in preclinical studies. This phase I, first-in-human, dose-escalation/-expansion study explored the pharmacokinetics, safety and tolerability, and preliminary antitumor activity of senaparib in Chinese patients with advanced solid tumors.

Patients and Methods:

Adults with advanced solid tumors who had failed ³1 line of prior systemic treatment were enrolled. Senaparib (once daily [QD]) dose was escalated from 2 mg until the maximum tolerated dose (MTD)/recommended phase II dose (RP2D) using a modified 3 + 3 design. Dose expansion included: dose groups with ≥1 objective response and one dose higher, as well as those at the MTD/RP2D. Primary objectives were to evaluate the safety and tolerability, and determine the MTD and/or RP2D of senaparib.

Results:

Fifty-seven patients were enrolled across 10 dose groups (2-120 mg QD, and 50 mg twice daily). No dose-limiting toxicities were observed. The most common senaparib-related adverse events were anemia (80.9%), white blood cell count decreased (43.9%), platelet count decreased (28.1%), and asthenia (26.3%). Senaparib exposure increased dose proportionately at 2-80 mg; absorption saturated at 80-120 mg. Senaparib accumulation was minimal after repeated QD administration (accumulation ratio=1.1-1.5). The objective response rate was 22.7% (n=10/44) overall (all partial responses) and 26.9% (n=7/26) for patients harboring BRCA1/BRCA2 mutations. Disease control rates were 63.6% and 73.1%, respectively.

Conclusions:

Senaparib was well tolerated and demonstrated promising antitumor activity in Chinese patients with advanced solid tumors. The RP2D for this clinical study in China was identified as 100 mg QD.

ClinicalTrials.gov Identifier:

NCT03508011

2011-03-26·Frontiers in Anti-Cancer Drug Discovery

Small Molecule Vascular Disrupting Agents: Potential New Drugs for Cancer Treatment, a 2009 Update

作者: Cai, Sui Xiong

A review.Vascular disrupting agents (VDAs) are a new class of potential anticancer drugs that selectively destroy tumor vasculature and shutdown blood supply to solid tumors, causing extensive tumor cell necrosis.VDAs target established tumor blood vessels, which are distinct from antiangiogenic agents that prevent the formation of new blood vessels.There are two types of VDAs, small mols. and ligand-directed agents.Most of the small mol. VDAs are tubulin inhibitors, including CA4P, ZD6126, AVE8062, OXi-4503, NPI-2358, MN-029, EPC2407, CYT997, MPC-6827, ABT-751 and TZT-1027.The others are synthetic flavonoids including FAA and DMXAA that induce the production of local cytokines such as TNF-alpha.VDAs have shown good antitumor efficacy in animal models, especially in combination with established anticancer agents.Several VDAs, including CA4P and DMXAA, have demonstrated good safety profile as well as some promising efficacy in phase I and II clin. trials.Currently CA4P, DMXAA and AVE8062 are in phase III clin. trials, NPI-2358, CYT997, MPC-6827 and ABT-751 are in phase II clin. trials, and OXi-4503 and EPC2407 are in phase I clin. trials.This review will focus on recent progress in the discovery and development of small mol. VDAs, including recently published patent applications and issued patents related with small mol. VDAs.

491

项与南京英派药业有限公司相关的新闻（医药）

2025-04-25

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君实生物特瑞普利单抗一线治疗黑色素瘤在中国获批

临床结果临床3期CSCO会议免疫疗法

2025-04-24

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邦耀生物刘明耀、杜冰教授团队《Cancer Cell 》重磅综述：CAR-T攻克实体瘤，未来可期！

免疫疗法细胞疗法临床研究临床结果

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药物(靶点)	适应症	全球最高研发状态

塞纳帕利 ( PARP1 x PARP2 )	晚期恶性实体瘤更多	临床2期
IMP-9064 ( ATR )	晚期恶性实体瘤更多	临床1/2期
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