An Open, Multicenter, Phase Ib/II Clinical Study of IMP4297 Capsule (JS109) Combined With Irinotecan in the Treatment of Advanced Malignant Solid Tumors

The Phase Ib study was designed to evaluate the safety of JS109 in combination with irinotecan in the treatment of advanced solid tumors and to determine the Phase II recommended dose (RP2D). The Phase II study was designed to evaluate the efficacy and safety of the combination regimen in patients with extensive small-cell lung cancer (SCLC) that failed first-line platinum-containing regimen.

Start Date23 Mar 2023

Sponsor / Collaborator

Shanghai Junpaiyingshi Pharmaceutical Co., Ltd.

CTR20221034

/ CompletedNot Applicable

一项开放、随机、单剂量、二交叉、比较中国健康受试者在空腹状态下IMP4297胶囊两种规格（10 mg和20 mg）的生物等效性研究

[Translation] An open-label, randomized, single-dose, two-way crossover bioequivalence study comparing two strengths of IMP4297 capsules (10 mg and 20 mg) in Chinese healthy subjects in the fasting state

主要目的：中国健康男性受试者在空腹状态下，单次口服100mg ( 5 x 20 mg规格）IMP4297 胶囊和100mg （10 x 10 mg规格）IMP4297胶囊，确定两者是否具有生物等效性。次要目的：在空腹状态下，评估中国健康男性受试者单次口服100mg( 5 x 20 mg规格）IMP4297 胶囊和100mg ( 10 x 10 mg规格）IMP4297胶囊后的安全性和耐受性；初步评估IMP4297对QT 间期的影响。

[Translation]

Primary objective: To determine whether the two are bioequivalent after a single oral administration of 100 mg (5 x 20 mg) IMP4297 capsules and 100 mg (10 x 10 mg) IMP4297 capsules to healthy Chinese male subjects in the fasting state. Secondary objective: To evaluate the safety and tolerability of a single oral administration of 100 mg (5 x 20 mg) IMP4297 capsules and 100 mg (10 x 10 mg) IMP4297 capsules to healthy Chinese male subjects in the fasting state; to preliminarily evaluate the effect of IMP4297 on the QT interval.

Start Date08 Jun 2022

Sponsor / Collaborator

IMPACT Therapeutics, Inc.

100 Clinical Results associated with Senaparib

100 Translational Medicine associated with Senaparib

100 Patents (Medical) associated with Senaparib

Literatures (Medical) associated with Senaparib

02 Jan 2025·Molecular Cancer Therapeutics

The Discovery of a Potent PARP1 Inhibitor Senaparib

Article

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

AbstractPARP1 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.

01 Jun 2024·Nature Medicine

Senaparib as first-line maintenance therapy in advanced ovarian cancer: a randomized phase 3 trial

Article

Author: Xia, Bairong ; Liang, Zhiqing ; Xu, Cong ; Wang, Xin ; Tang, Ying ; Hsieh, Chih-Yi ; Wen, Hongwu ; Qu, Pengpeng ; Fei, Junwei ; Wang, Jing ; Pan, Hongming ; Wang, Wei ; Wang, Ke ; Liu, Jihong ; Zheng, Hong ; Wu, Xiaohua ; Zhu, Jianqing ; Li, Guiling ; Kong, Beihua ; Jiang, Kui ; the FLAMES Investigators ; Cai, Yunlang ; Lou, Ge ; Chen, Youguo ; Lin, An ; Yang, Zhijun ; Yao, Shuzhong ; Wang, Li ; Huang, Yi ; Wang, Xiaobin ; Lin, Zhongqiu ; Chen, Xuejun ; Hao, Min

Poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitors as maintenance therapy after first-line chemotherapy have improved progression-free survival in women with advanced ovarian cancer; however, not all PARP inhibitors can provide benefit for a biomarker-unselected population. Senaparib is a PARP inhibitor that demonstrated antitumor activity in patients with solid tumors, including ovarian cancer, in phase 1 studies. The multicenter, double-blind, phase 3 trial FLAMES randomized (2:1) 404 females with advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage III-IV) and response to first-line platinum-based chemotherapy to senaparib 100 mg (n = 271) or placebo (n = 133) orally once daily for up to 2 years. The primary endpoint was progression-free survival assessed by blinded independent central review. At the prespecified interim analysis, the median progression-free survival was not reached with senaparib and was 13.6 months with placebo (hazard ratio 0.43, 95% confidence interval 0.32-0.58; P < 0.0001). The benefit with senaparib over placebo was consistent in the subgroups defined by BRCA1 and BRCA2 mutation or homologous recombination status. Grade ≥3 treatment-emergent adverse events occurred in 179 (66%) and 27 (20%) patients, respectively. Senaparib significantly improved progression-free survival versus placebo in patients with advanced ovarian cancer after response to first-line platinum-based chemotherapy, irrespective of BRCA1 and BRCA2 mutation status and with consistent benefits observed between homologous recombination subgroups, and was well tolerated. These results support senaparib as a maintenance treatment for patients with advanced ovarian cancer after a response to first-line chemotherapy. ClinicalTrials.gov identifier: NCT04169997 .

11 Dec 2023·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

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

AbstractBackgroundSenaparib, 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 MethodsAdults 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.ResultsFifty-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.ConclusionsSenaparib 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 IdentifierNCT03508011

News (Medical) associated with Senaparib

17 Jan 2025

·www.prnewswire.com

Senaparib Approved by NMPA for 1L Maintenance Therapy in Ovarian Cancer

SHANGHAI, Jan. 16, 2025 /PRNewswire/ -- IMPACT Therapeutics ("IMPACT"), a biopharmaceutical company focusing on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, is pleased to announce that Senaparib Capsules (派舒宁®）has received marketing authorization in China from National Medical Products Administration (NMPA) as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. Senaparib, discovered and developed by IMPACT, is a potent and novel PARP 1/2 inhibitor. Its distinctive molecular structure provides it with high in vitro and in vivo activity, exceptional target selectivity and wide safety window. The approval is based on FLAMES Study. The study is a randomized, double-blind, placebo-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of Senaparib as monotherapy for the maintenance treatment of patients with advanced ovarian cancer who had completed first-line chemotherapy and achieved either a complete response (CR) or partial response (PR). The results of FLAMES Study showed that Senaparib demonstrated significant improvement in median PFS compared to placebo (PFS not reached vs 13.6 months, HR 0.43, P < 0.0001), irrespective of BRCA status. Senaparib demonstrated a tolerable safety profile, with no noticeable safety issues. [1]The results also indicated that both HRD positive and HRD negative populations derived benefit from Senaparib maintenance therapy, highlighting the potential of Senaparib for broad clinical application. The results of this study will strongly support Senaparib as the Standard of Care for first-line maintenance therapy in patients with newly diagnosed ovarian cancer. The top-line results of the study were initially presented as a late breaking oral presentation at ESMO in 2023 and presented at CSCO 2024. On May 15, 2024, the internationally renowned medical journal Nature Medicine also published the results titled "Senaparib as first-line maintenance therapy in advanced ovarian cancer: a randomized phase 3 trial."[1] Ovarian cancer is one of the most common lethal female reproductive malignancies. According to GLOBOCAN 2020 data, the global incidence of ovarian cancer is amounted to 310,000 cases and mortality is amounted to 210,000. According to the latest national cancer statistics released by National Cancer Center in 2024, there were 61,100 new cases of ovarian cancer and 32,600 deaths in China in 2022, making it the most lethal gynecological tumor. Due to the insidious and non-specific early symptoms of ovarian cancer, about 80% of patients are already in advanced stage when they are diagnosed, and the 5-year survival rate is only 41.8%. [2]Although ovarian cancer may be resolved after initial platinum-containing chemotherapy, most patients inevitably face recurrence, and there remains a significant unmet clinical need for treatment in the ovarian cancer patient population. In recent years, PARP inhibitors are changing the therapeutic landscape of ovarian cancer, with maintenance therapy extending the duration of sustained remission after platinum-containing chemotherapy and delaying disease recurrence. In December 2023, IMPACT entered into a collaboration agreement with Zhongmei Huadong Pharmaceutical Co., Ltd, a subsidiary of Huadong Medicine Co., Ltd (SZ.000963) (collectively, "Huadong Medicine") for the commercialization of Senaparib. Under the collaboration agreement, Huadong Medicine receives exclusive promotion rights of Senaparib in mainland China. Huadong Medicine is deeply involved in the field of gynecological oncology. Senaparib and Huadong Medicine's approved mirvetuximab soravtansine-gynx (ELAHERE®) can provide solutions for ovarian cancer patients with different stages of the disease, sharing expert networks, research and clinical resources, promoting and developing together to form an effective and highly synergistic relationship. Dr. Sui Xiong Cai, Chief Executive Officer of IMPACT said: "It is our great pleasure to share with you the successful approval of Senaparib for the Chinese market, which is another strong proof of the excellence of IMPACT's in-house synthetic lethality R&D platform and the R&D execution team. Leveraging Huadong Medicine's extensive commercial experiences in promoting novel therapeutics, we hope that Senaparib will reach more ovarian cancer patients soon and bring new treatment options for first-line maintenance therapy in advanced ovarian cancer." About IMPACT Therapeutics IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. IMPACT Therapeutics has assembled one of the most comprehensive DNA damage responses (DDR) global pipeline of novel drug candidates generated by in-house discovery efforts and is expanding to other novel synthetic lethality targets to broaden its pipeline. IMPACT's pipeline products include PARP inhibitor Senaparib (IMP4297), WEE1 inhibitor (IMP7068), ATR inhibitor (IMP9064), and PARP1 selective inhibitor (IMP1734, in collaboration with Eikon Therapeutics), as well as other novel DDR pathway inhibitors. The most advanced development program, PARP inhibitor Senaparib (IMP4297), has been in clinical Phase II/III studies globally, including China, in ovarian cancer, small cell lung cancer and other indications. The Phase III clinical study (FLAMES Study) of Senaparib for advanced ovarian cancer maintenance treatment following first-line therapy met primary endpoint, with best-in-class efficacy and safety profile. Based on the results of the FLAMES study, the National Medicines Products Administration (NMPA) has approved the new drug application for Senaparib. The Wee1 inhibitor IMP7068 and the ATR inhibitor IMP9064 have been investigated in Phase I clinical studies in several countries and regions around the world, including U.S. and China, and the recommended Phase II dose (RP2D) has been established. PARP1 selective inhibitor IMP1734 has obtained IND clearance from FDA and NMPA, as well as completed FPI in early 2024. For additional information, please visit IMPACT Therapeutics Contact: +86 21 6841 1121 [email protected] SOURCE IMPACT Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug ApprovalLicense out/inPhase 1

17 Jan 2025

·www.pharmaceutical-technology.com

IMPACT ovarian cancer capsules authorised in China

Senaparib is a PARP 1/2 inhibitor used to treat ovarian cancer. Credit: Jo Panuwat D/Shutterstock. IMPACT Therapeutics has received the China National Medical Products Administration (NMPA) marketing authorisation for Senaparib capsules to treat ovarian cancer. The authorisation allows the therapy to be used as a single agent for the maintenance treatment of adult individuals with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who showed a response after first-line platinum-based chemotherapy. Senaparib, a poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor developed by the company, stands out due to its unique molecular structure, which ensures high activity, selectivity, and a broad safety margin. The approval is supported by the outcomes from the randomised, placebo-controlled Phase III FLAMES study that assessed the therapy’s safety and efficacy. In the study, subjects with advanced ovarian cancer who had responded to chemotherapy showed a significant improvement in median progression-free survival (PFS) when treated with the therapy against placebo. Its safety profile was also found to be tolerable, with no significant safety concerns identified. Both homologous recombination deficiency (HRD)-positive and HRD-negative subjects’ groups benefited from Senaparib maintenance therapy, suggesting its potential as a standard of care for first-line maintenance therapy in patients with newly diagnosed ovarian cancer. In December 2023, the company partnered with Huadong Medicine subsidiary, Zhongmei Huadong Pharmaceutical, for the commercialisation of the therapy in mainland China. IMPACT Therapeutics CEO Dr Sui Xiong Cai stated: “It is our great pleasure to share with you the successful approval of Senaparib for the Chinese market, which is another strong proof of the excellence of IMPACT’s in-house synthetic lethality research and development (R&D) platform and the R&D execution team. Leveraging Huadong Medicine’s extensive commercial experiences in promoting novel therapeutics, we hope that Senaparib will reach more ovarian cancer patients soon and bring new treatment options for first-line maintenance therapy in advanced ovarian cancer.”

Phase 3Drug ApprovalClinical Result

01 Jun 2023

·www.biospace.com

Impact Therapeutics Entered into Global Partnership with Eikon Therapeutics to Develop and Commercialize PARP1 Selective Inhibitors

SHANGHAI and HAYWARD, Calif., June 1, 2023 /PRNewswire/ -- IMPACT Therapeutics ("Impact"), a biopharmaceutical company focusing on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, and Eikon Therapeutics ("Eikon"), a biotechnology company that is advancing breakthrough therapeutics through the purposeful integration of engineering and science today announced that the companies have entered into a global license and collaboration agreement for PARP1 selective inhibitors including IMP1734, which is anticipated to enter into Phase I clinical study in 2023. Under the collaboration agreement, Eikon received an exclusive license from Impact to co-develop, register, manufacture, and commercialize IMP1734 and other PARP1 selective inhibitors globally, excluding Greater China (mainland China, Hong Kong, Macau, and Taiwan). "We are delighted to establish the global partnership with Eikon, whose leadership team has a well-documented track record of developing some of the world's most therapeutically meaningful and commercially successful oncology medicines." said Sui Xiong Cai, Ph.D., Chief Executive Officer of IMPACT Therapeutics. "As a company committed to develop innovative medicines globally, based on our deep understanding of synthetic lethality, we believe this partnership will allow us to accelerate the development of our PARP1 selective inhibitor program combining Impact and Eikon's scientific, clinical, regulatory expertise and financial resources. We look forward to working with Eikon in bringing new cancer medicines to patients in China and across the globe." "Impact has a sophisticated discovery engine that has generated an extensive pipeline of new molecules, including the development of senaparib, a dual PARP1/2 inhibitor that has been recently reported to improve outcomes in patients with advanced ovarian cancer. Eikon is delighted to partner with Impact scientists to help develop IMP1734 and other selective PARP1 inhibitors that exploit DNA damage response aberrations often found in tumors to selectively kill cancer cells," said Roger M. Perlmutter, M.D., Ph.D., Chief Executive Officer and Board Chair of Eikon Therapeutics. "Eikon is confident that we can leverage our expertise, resources and proprietary technology platforms, in partnership with Impact, to bring these important new PARP1 inhibitor therapies to patients who are awaiting new and better treatment options." About IMPACT Therapeutics IMPACT Therapeutics is a biopharmaceutical company dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. Impact has assembled one of the most comprehensive DNA damage response ("DDR") global pipeline of novel drug candidates generated by in-house discovery efforts, including PARP1/2 inhibitor senaparib (IMP4297), WEE1 inhibitor IMP7068, ATR inhibitor IMP9064, PARP1 selective inhibitor IMP1734, and is expanding to other novel synthetic lethality targets to broaden its pipeline. IMPACT Therapeutics can be found via the website. About Eikon Therapeutics Eikon Therapeutics is a drug discovery and development company working to advance breakthrough therapeutics through the purposeful integration of engineering and science. Our proprietary platform leverages Nobel Prize-winning super-resolution microscopy, advanced engineering, and high-performance computing to measure the real-time movement of individual proteins and protein populations in living cells, with the goal of bringing important new medicines to people suffering from grievous illness. Eikon is headquartered in California and can be found online via our website or on Twitter or LinkedIn. About IMP1734 IMP1734 is a novel and highly PARP1 selective inhibitor with high potency of inhibiting PARP1 and low activity of inhibiting PARP2. Preclinical in vivo models had demonstrated high anti-tumor activities and a wide therapeutic window. The improved therapeutic index of IMP1734 over currently marketed non-selective PARP1/2 inhibitors supports its development as monotherapy and in combination with other agents. IMPACT Therapeutics Contact: Ke WANG, Senior Manager, Corporate Development ke.wang@impacttherapeutics.com Eikon Therapeutics Contact: Lisa McCormick Lavery, Vice President, Corporate Communications and Investor Relations media@eikontx.com

License out/inPhase 1

100 Deals associated with Senaparib

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Indication	Country/Location	Organization	Date
Fallopian Tube Carcinoma	CN	Shanghai Junpaiyingshi Pharmaceutical Co., Ltd.	16 Jan 2025
Primary peritoneal carcinoma	CN	Shanghai Junpaiyingshi Pharmaceutical Co., Ltd.	16 Jan 2025
Ovarian Epithelial Carcinoma	CN	Shanghai Junpaiyingshi Pharmaceutical Co., Ltd.	14 Jan 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fallopian Tube Carcinoma	NDA/BLA	CN	Shanghai Junshi Biosciences Co., Ltd.	28 Aug 2023
Ovarian Epithelial Carcinoma	NDA/BLA	CN	Shanghai Junshi Biosciences Co., Ltd.	28 Aug 2023
Primary peritoneal carcinoma	NDA/BLA	CN	Shanghai Junshi Biosciences Co., Ltd.	28 Aug 2023
Advanced Malignant Solid Neoplasm	Phase 2	KR	Shanghai Junpaiyingshi Pharmaceutical Co., Ltd.	28 Sep 2021
Advanced Malignant Solid Neoplasm	Phase 2	AU	Shanghai Junpaiyingshi Pharmaceutical Co., Ltd.	28 Sep 2021
Advanced Malignant Solid Neoplasm	Phase 2	US	Shanghai Junpaiyingshi Pharmaceutical Co., Ltd.	28 Sep 2021
Extensive stage Small Cell Lung Cancer	Phase 2	KR	Shanghai Junpaiyingshi Pharmaceutical Co., Ltd.	28 Sep 2021
Extensive stage Small Cell Lung Cancer	Phase 2	US	Shanghai Junpaiyingshi Pharmaceutical Co., Ltd.	28 Sep 2021
Extensive stage Small Cell Lung Cancer	Phase 2	AU	Shanghai Junpaiyingshi Pharmaceutical Co., Ltd.	28 Sep 2021
BRCA-mutated Ovarian Cancer	Discovery	CN	IMPACT Therapeutics, Inc.	11 Sep 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04089189 (SABRINA, ESMO 12023 \| ESMO 22023) Manual	Phase 2	Ovarian Cancer BRCA1 Mutation \| BRCA2 Mutation	93	Senaparib 100 mg	(edwldpjrnx) = hzgeanhhyx vcpkkdupxi (ozwilpusjj, 86.2 - 97.5) View more	Positive	22 Oct 2023
NCT04169997 (FLAMES, ESMO2023) Manual	Phase 3	Ovarian Cancer Maintenance	404	Senaparib	(iwhjvtgurd) = zunalkebxu elxjwyouzh (vhwarnrnec ) View more	Positive	20 Oct 2023
NCT04169997 (FLAMES, ESMO2023) Manual	Phase 3	Ovarian Cancer Maintenance	404	Placebo	(iwhjvtgurd) = xhpiqczift elxjwyouzh (vhwarnrnec ) View more	Positive	20 Oct 2023
FLAMES study (ESGO2023)	Phase 3	Ovarian Cancer Maintenance high-grade serous \| endometrioid tumors	404	Senaparib	(ulwxagbiyx) = wccpnhmyzg czmkmneaii (xuicdidadr )	Positive	28 Sep 2023
FLAMES study (ESGO2023)	Phase 3		404	Placebo	(ulwxagbiyx) = oxjwlytgph czmkmneaii (xuicdidadr )	Positive	28 Sep 2023
NCT04434482 (WCLC2023) Manual	Phase 1/2	Extensive stage Small Cell Lung Cancer	42	Senaparib + Temozolomide	(ktokouxmma) = ynwrxyxsxw ybzgwplqdh (wqzmvyubbc, 5.4 - 28.5) View more	Positive	12 Sep 2023
NCT04434482 (WCLC2023) Manual	Phase 1/2	Extensive stage Small Cell Lung Cancer	42	Senaparib + Temozolomide (Platinum sensitive)	(ktokouxmma) = pawspjjhgl ybzgwplqdh (wqzmvyubbc, 2.4 - 30.2) View more	Positive	12 Sep 2023
NCT03508011 (Pubmed)	Phase 1	Advanced Malignant Solid Neoplasm	57	Senaparib	(uckcvdinms) = epkxvmjjia yjuolnefqm (aunblrwttg ) View more	-	20 Jun 2023
NCT03507543 (Pubmed)	Phase 1	Advanced Malignant Solid Neoplasm	39	Senaparib	vqtmvgljjm(kftgypgizc) = Most treatment-emergent adverse events were grade 1-2 (91%). Seven patients (17.9%) reported hematologic treatment-emergent adverse events. Treatment-related adverse events occurred in eight patients (20.5%), and the most frequent was nausea (7.7%). Two deaths were reported after the end of study treatment, one of which was considered a complication from senaparib-related bone marrow failure. imvaoidxsr (twjfiqellx )	-	31 Jan 2023
NCT04434482 (ASCO2022) Manual	Phase 1	Extensive stage Small Cell Lung Cancer \| HR-positive/HER2-low Solid Tumors	14	Senaparib+Temozolomide	(ynnlzkpwkl) = The MTD and RP2D were determined as: senaparib 80 mg plus temozolomide 20 mg. iaagwtlicw (bakzdibpai ) View more	Positive	02 Jun 2022

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