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.

NCT05390944 / Unknown statusPhase 1

An Open-label, Randomized, Single-dose, Two-way Crossover Bioequivalence Study to Compare Two Strengths (10 mg and 20 mg) of IMP4297 Capsules in Healthy Chinese Subjects Under Fasting Condition

An open-label, randomized, single-dose, two-way crossover bioequivalence study to compare two strengths (10 mg and 20 mg) of IMP4297 capsules in healthy Chinese subjects under fasting condition.

Start Date08 Jun 2022

Sponsor / Collaborator

IMPACT Therapeutics, Inc.Startup

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

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: Edward Tian, Ye ; Xu, Cong ; Xiong Cai, Sui ; Ji, Dongmei ; Zhang, Pin ; Hsieh, Chih-Yi ; Zhang, Shun ; 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

01 Jun 2023·British journal of clinical pharmacology

Effect of a strong CYP3A4 inhibitor and inducer on the pharmacokinetics of senaparib (IMP4297) in healthy volunteers: A drug–drug interaction study

Article

Author: Cai, Sui Xiong ; Zhang, Yanxin ; Xu, Pingsheng ; Liu, Lan ; Zhang, Ming ; Xu, Sumei ; Hu, Xiaolei ; Shi, Huiyan ; Hsieh, Chih‐Yi ; Zhang, Hongxia ; Liu, Wanli ; Li, Xiaomin ; Liu, Ping

Aims:

A phase I open‐label study assessed the effect of multiple oral doses of a potent CYP3A4 inhibitor (itraconazole) and inducer (rifampicin) on the pharmacokinetic profile of a single oral dose of senaparib, a novel, highly potent poly‐(ADP‐ribose) polymerase 1/2 inhibitor and CYP3A4 substrate, in Chinese healthy male volunteers (HMV).

Methods:

Adult HMV were enrolled to the itraconazole or rifampicin group (n = 16 each). In Period 1, all participants received a single oral dose of senaparib 40 mg (itraconazole group) or 100 mg (rifampicin group). In Period 2, the same dose was coadministered with itraconazole (200 mg) and rifampicin (600 mg), respectively. The primary endpoints were senaparib exposure parameters.

Results:

Coadministration with itraconazole significantly increased exposure of senaparib and decreased that of its major metabolites M9 and M14. Maximum plasma senaparib concentration (Cmax) was increased by ~79% and area under the concentration–time curve (AUC) increased by ~2.8‐fold. Coadministration with rifampicin significantly reduced the Cmax and AUC of senaparib by ~59 and 83%, respectively. The Cmax for both M9 and M14 was slightly increased, although AUC was decreased. All treatment‐emergent adverse events were grade ≤2, regardless of the treatment administered.

Conclusion:

In Chinese HMV, the exposure of senaparib was significantly increased when coadministered with itraconazole and significantly decreased when coadministered with rifampicin. It is recommended to avoid concomitant use of senaparib and strong inhibitors or inducers of CYP3A4.

01 Apr 2023·Cancer

A phase 1 dose‐escalation study of the poly(ADP‐ribose) polymerase inhibitor senaparib in Australian patients with advanced solid tumors

Article

Author: Voskoboynik, Mark ; de Souza, Paul ; Zhang, Ming ; Cooper, Adam ; Li, Baoyue ; Ma, Ning ; Gao, Bo ; Hoon, Siao ; Wang, Chen ; Wilkinson, Kate ; Tian, Ye Edward ; Xu, Cong ; Zhou, Ruiyu ; Wang, Xiaozhu ; Cai, Suixiong ; Hsieh, Chih‐Yi ; Guo, Mingchuan ; Bao, Jun

Abstract:

Background:

Senaparib is a novel, selective poly(ADP‐ribose) polymerase‐1/2 inhibitor with strong antitumor activity in preclinical studies. This first‐in‐human, phase 1, dose‐escalation study examined the safety and preliminary efficacy of senaparib in patients with advanced solid tumors.

Methods:

Patients with advanced solid tumors were enrolled from three centers in Australia, using a conventional 3 + 3 design. Dose‐escalation cohorts continued until the maximum tolerated dose or a recommended phase 2 dose was determined. Patients received one dose of oral senaparib and, if no dose‐limiting toxicity occurred within 7 days, they received senaparib once daily in 3‐week cycles. The primary end points were safety and tolerability.

Results:

Thirty‐nine patients were enrolled at 10 dose levels ranging from 2 to 150 mg. No dose‐limiting toxicities were observed in any cohort. 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. Pharmacokinetic analysis indicated that senaparib the accumulation index was 1.06–1.67, and absorption saturation was 80–150 mg daily. In 22 patients with evaluable disease, the overall response rate was 13.6%, and the disease control rate was 81.8%. The overall response rate was 33.3% for the BRCA mutation‐positive subgroup and 6.3% for the nonmutated subgroup.

Conclusions:

Senaparib was well tolerated in Australian patients with advanced solid tumors, with encouraging signals of antitumor activity. The recommended phase 2 dose for senaparib was determined to be 100 mg daily.

ClinicalTrials.gov ID:

NCT03507543.

News (Medical) associated with Senaparib

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

12 Apr 2023

·www.fiercebiotech.com

Trailing AstraZeneca and Merck, Junshi reports phase 3 ovarian cancer success for Lynparza rival

Junshi Biosciences plans to engage with regulators “in the near future.” Junshi Biosciences has established its credentials as the next challenger for the increasingly congested Chinese PARP inhibitor market. A phase 3 trial of the candidate hit its primary endpoint, setting Junshi up to compete with products including AstraZeneca and Merck & Co.’s Lynparza for the ovarian cancer space. AstraZeneca and Merck won the first approval for a PARP inhibitor in China in 2019, but their monopoly on the market was short-lived. The next year, Zai Lab won approval for GSK’s Zejula and Jiangsu Hengrui Pharmaceuticals got the green light to sell AiRuiYi. BeiGene joined the party in May 2021. The drugs have slightly different labels and, according to a 2022 paper, Lynparza and Zejula are the most widely used. Despite the thicket of competitors, Junshi sees an opportunity for another PARP inhibitor. The Chinese drug developer secured access to a candidate, senaparib, in 2020 by forming a joint venture with Impact Therapeutics. At the time of the deal, Impact was eight months into a phase 3 clinical trial designed to show senaparib extends progression-free survival when given as a maintenance therapy to BRCA-positive ovarian cancer patients after first-line chemotherapy. The top-line findings, released late Tuesday in the U.S., showed the primary endpoint met the predefined efficacy boundary. The top-line data release lacks the figures behind the hit on the primary endpoint and details of how the drug candidate performed on other measures of safety and efficacy. Junshi thinks it has the data to file for approval, though, and plans to work with Impact to engage with regulators “in the near future.” In the absence of data from the trial, it is hard to gauge how senaparib is likely to fare in a market with established incumbent products, but the little that is known points to some potential ways for Junshi and Impact to try to differentiate the treatment. Jianjun Zou, president of global research and development at Junshi, hailed the trial as “the first phase 3 clinical study of a domestically developed PARP inhibitor that has achieved positive results for advanced ovarian cancer maintenance treatment following first-line therapy” in a statement. Zou added that the PARP inhibitor significantly extended progression-free survival regardless of BRCA mutation status. BRCA mutation, according to local pathological diagnosis, was on the inclusion criteria for the clinical trial. AiRuiYi was the first domestically developed PARP inhibitor to hit the Chinese market, but its approval in 2020 was limited to patients with the germline BRCA mutation who had undergone second-line or above chemotherapy. Zejula was the first PARP drug approved in China in first-line and recurrent maintenance treatment settings regardless of biomarker status, but it originated outside of the country.

Phase 3Clinical ResultDrug ApprovalLicense out/in

12 Apr 2023

·www.globenewswire.com

Junshi Biosciences Announces Phase 3 Clinical Study of Senaparib for Advanced Ovarian Cancer Maintenance Treatment Following First-line Therapy Met Primary Endpoint

SHANGHAI, China, April 11, 2023 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, today announced that a randomized, double-blind, placebo-controlled, multi-center phase III clinical study (“FLAMES Study”, NCT04169997) investigating the poly (ADP-ribose) polymerase (“PARP”) inhibitor, senaparib (product code: JS109/IMP4297), had finished its pre-specified interim analysis. Senaparib was jointly developed by Junshi Biosciences and IMPACT Therapeutics, Inc. (“IMPACT Therapeutics”), as a maintenance treatment following first-line platinum-based chemotherapy in patients with International Federation of Gynecology and Obstetrics (“FIGO”) stage III/IV ovarian carcinoma, fallopian tube cancer or primary peritoneal cancer who achieved a complete response or partial response. The Independent Data Monitoring Committee (the “IDMC”) concluded that the primary endpoint had met the pre-defined efficacy boundary. Junshi Biosciences and IMPACT Therapeutics will communicate with regulatory authorities regarding a new drug application for the drug in the near future. Dr. Jianjun ZOU, President of Global Research and Development at Junshi Biosciences, commented on the positive results of the FLAMES study. "As the first phase III clinical study of a domestically developed PARP inhibitor that has achieved positive results for advanced ovarian cancer maintenance treatment following first-line therapy, the FLAMES study’s interim analysis results show that senaparib can significantly extend the progression free survival (PFS) of patients with advanced ovarian cancer, regardless of the patient’s breast cancer susceptibility gene (BRCA) mutation status. We will collaborate with our partner IMPACT Therapeutics to engage in communication with regulatory agencies and look forward to expanding our commercial cancer drug portfolio to provide more effective treatment options at a lower cost for patients with advanced ovarian cancer.” Ovarian cancer is one of the most commonly fatal malignant tumors affecting the female genital tract. According to GLOBOCAN 2020 data, around 310,000 new cases of ovarian cancer are diagnosed across the world annually, resulting in roughly 210,000 deaths every year. As the early symptoms of ovarian cancer are hidden and non-specific, around 80% of the patients with ovarian cancer are diagnosed at an advanced stage, with a five-year survival rate of only 40%. Although primary platinum-based chemotherapy can help alleviate ovarian cancer, most patients inevitably experience cancer relapse. Over the years, PARP inhibitor has revolutionized the treatment of ovarian cancer. In particular, PARP inhibitor maintenance treatment can extend the response time following first-line platinum-based chemotherapy and delay cancer relapse. About the FLAMES Study The FLAMES Study is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of senaparib as monotherapy maintenance treatment following first-line platinum-based chemotherapy in patients with FIGO stage III/IV ovarian cancer who have achieved complete response (CR) or partial response (PR). About Senaparib As a novel targeted anti-tumor drug, senaparib is a PARP inhibitor. The clinical study of senaparib was supported by the national special project for innovative manufacturing of major new drugs under the 13th Five-Year Plan, and the inspection and acceptance procedures were completed smoothly. In August 2022, the fixed dose combination capsules of senaparib and temozolomide for the treatment of adult patients with small cell lung cancer was granted orphan-drug designation by the U.S. Food and Drug Administration. In August 2020, Junshi Biosciences and IMPACT Therapeutics entered into a joint venture agreement to form a joint venture company. The joint venture company mainly engages in the research and development, and commercialization of small molecule anti-tumor drugs, including senaparib. IMPACT Therapeutics contributed the asset rights of senaparib within the joint venture territories of mainland China, Hong Kong and Macau Special Administrative Region. The Company and IMPACT Therapeutics each owns a 50% equity interest of the joint venture company. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA monoclonal antibody for the treatment of various cancers was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. In 2021, JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 administered with bamlanivimab, was granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. Meanwhile, VV116 (deuremidevir hydrobromide), a novel oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, has been approved for marketing in China and Uzbekistan. The JS016 and VV116 programs are a part of the company’s continuous efforts towards innovation for disease control and prevention of the global pandemic. Junshi Biosciences has about 3,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc). For more information, please visit: http://junshipharma.com. Junshi Biosciences Contact InformationIR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800 PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105 8800

Phase 3Clinical ResultOrphan DrugDrug Approval

100 Deals associated with Senaparib

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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
Fallopian Tube Carcinoma	NDA/BLA	CN	IMPACT Therapeutics, Inc.	28 Aug 2023
Ovarian Cancer	NDA/BLA	CN	Shanghai Junpaiyingshi Pharmaceutical Co., Ltd.	28 Aug 2023
Ovarian Cancer	NDA/BLA	CN	Wuxi Apptec, Inc.	28 Aug 2023
Ovarian Epithelial Carcinoma	NDA/BLA	CN	IMPACT Therapeutics, Inc.	28 Aug 2023
Ovarian Epithelial Carcinoma	NDA/BLA	CN	Shanghai Junshi Biosciences Co., Ltd.	28 Aug 2023
Primary peritoneal carcinoma	NDA/BLA	CN	IMPACT Therapeutics, Inc.	28 Aug 2023
Primary peritoneal carcinoma	NDA/BLA	CN	Shanghai Junshi Biosciences Co., Ltd.	28 Aug 2023
Metastatic castration-resistant prostate cancer	Phase 2	US	IMPACT Therapeutics, Inc.	31 Dec 2021
Metastatic castration-resistant prostate cancer	Phase 2	CN	IMPACT Therapeutics, Inc.	31 Dec 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04089189 (SABRINA, ESMO2023) Manual	Phase 2	Ovarian Cancer BRCA1 Mutation \| BRCA2 Mutation	93	Senaparib 100 mg	samiwxhqpj(iyeirltkuo) = weuypacfyu gdhlfgkkai (hoaglcfdvb, 86.2 - 97.5) View more	Positive	22 Oct 2023
NCT04169997 (FLAMES, ESMO2023) Manual	Phase 3	Ovarian Cancer Maintenance	404	Senaparib	nykvnyizbd(luvgyyybet) = kssxpsyqcy lyvjsedfhp (ptueqohvwo ) View more	Positive	20 Oct 2023
NCT04169997 (FLAMES, ESMO2023) Manual	Phase 3	Ovarian Cancer Maintenance	404	Placebo	nykvnyizbd(luvgyyybet) = aywcfistuj lyvjsedfhp (ptueqohvwo ) View more	Positive	20 Oct 2023
FLAMES study (ESGO2023)	Phase 3	Ovarian Cancer Maintenance high-grade serous \| endometrioid tumors	404	Senaparib	jhairrddzg(aimbfjjupt) = xzlcxtcxkt zzoufdzmrz (rbqfvkkafh )	Positive	28 Sep 2023
FLAMES study (ESGO2023)	Phase 3		404	Placebo	jhairrddzg(aimbfjjupt) = tbzqdpuopj zzoufdzmrz (rbqfvkkafh )	Positive	28 Sep 2023
NCT04434482 (WCLC2023) Manual	Phase 1/2	Extensive stage Small Cell Lung Cancer	42	Senaparib + Temozolomide	wooeamhojs(jckwhjoqov) = ckzhkrjoyr iqnjttjicg (jsrppeortg, 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)	wooeamhojs(jckwhjoqov) = mhgisdlwpa iqnjttjicg (jsrppeortg, 2.4 - 30.2) View more	Positive	12 Sep 2023
NCT03508011 (Pubmed)	Phase 1	HR-positive/HER2-low Solid Tumors	57	Senaparib	qzxrlcfsnk(mjbioqjxjs) = bvbjyzlgcw eizpzcirum (lwjxphvquh ) View more	-	20 Jun 2023
NCT03507543 (Pubmed)	Phase 1	HR-positive/HER2-low Solid Tumors	39	Senaparib	ihqcqhsxxw(ywthrnhskj) = 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. nqvrfiedwk (gvpqrsaaly )	-	31 Jan 2023
NCT04434482 (ASCO2022) Manual	Phase 1	Extensive stage Small Cell Lung Cancer \| HR-positive/HER2-low Solid Tumors	14	Senaparib+Temozolomide	xjbodxpkrr(jkveybrlbb) = The MTD and RP2D were determined as: senaparib 80 mg plus temozolomide 20 mg. vziocwdhuo (ghbprmkkzl ) View more	Positive	02 Jun 2022

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