[Translation] An open-label, multicenter, first-in-human, phase I/II study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of IMP1734, a selective PARP1 inhibitor, in patients with advanced solid tumors

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

[Translation]

Evaluate the safety and tolerability of IMP1734, determine the maximum tolerated dose (or highest achievable dose) and recommended dose expansion (RDE), and assess the anti-tumor activity of IMP1734, evaluate the pharmacokinetic (PK) characteristics and efficacy of IMP1734 in patients with advanced solid tumors after single/multiple administrations, evaluate the pharmacodynamic (PD) characteristics of IMP1734 in patients with advanced solid tumors, the relationship between efficacy and biomarkers, the effect on QTc interval, food effect, etc.

Start Date13 Mar 2024

Sponsor / Collaborator

IMPACT Therapeutics, Inc.Startup

NCT06253130 / RecruitingPhase 1/2

A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation, Dose-optimization, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PARP1 Selective Inhibitor, IMP1734, as Monotherapy in Patients With Advanced Solid Tumors

This study will evaluate the preliminary efficacy of IMP1734 in patients with recurrent advanced/metastatic breast cancer, ovarian cancer and metastatic castrate resistant prostate cancer (mCRPC) with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) genes.

Start Date11 Dec 2023

Sponsor / Collaborator

Eikon Therapeutics, Inc.Startup

[+1]

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

100 Clinical Results associated with IMPACT Therapeutics, Inc.

0 Patents (Medical) associated with IMPACT Therapeutics, Inc.

Literatures (Medical) associated with IMPACT Therapeutics, Inc.

01 Jun 2024·Journal of Clinical Oncology

A first-in-human (FIH), phase 1/2, dose-escalation, dose-optimization, and dose-expansion study of PARP1-selective inhibitor IMP1734 in participants with advanced solid tumors.

Author: Zhang, Congcong ; Call, Justin A ; Krishnan, Suba ; He, Jenna ; Sonpavde, Guru P. ; Garmezy, Benjamin ; Rasco, Drew W. ; Liu, Lan ; Russo, Giuseppe ; Chen, Viola ; Niu, Tiantian ; Kochan, Jarema ; Rebello, Sam ; Falchook, Gerald Steven

TPS3191 Background: PARP inhibitors (PARPi) selectively kill tumor cells harboring genetic mutations in critical DNA repair genes (e.g., BRCA1/2). While several approved nonselective PARPi have provided robust anti-tumor activity, they are associated with significant hematologic toxicities that limit dose intensity and clinical benefit. Drugs that selectively inhibit PARP1 but spare PARP2 may improve the risk-benefit profile for this class of therapies by retaining anti-tumor activity while avoiding PARP2-related toxicities. IMP1734 (EIK1003) is a potent PARP1-selective inhibitor that inhibits tumor growth in nonclinical models and may widen the therapeutic index in tumors where non-selective PARPi have demonstrated efficacy. Methods: Study EIK1003-001 (IMP1734-101) is a global, multi-center, Phase 1/2 study evaluating the safety and potential antitumor activity of IMP1734 in participants with advanced solid tumors. The study has 3 parts: Part 1 (FIH; Dose Escalation), Part 2 (Dose Optimization), and Part 3 (Dose Expansion at the recommended dose for expansion [RDE]). Part 1 of this study is currently enrolling and consists of dose escalation of IMP1734 in study participants with advanced/recurrent/metastatic ovarian, breast, or prostate cancer with suspected deleterious/deleterious mutations in a pre-specified panel of homologous recombination repair (HRR) genes (n = 70). Eligible participants must be ≥ 18 years of age, have histologically or cytologically confirmed tumors as indicated in each study part, and at least 1 RECIST v1.1-measurable lesion and/or pre-specified serum tumor-specific marker. All participants must have a deleterious or suspected deleterious mutation in select HRR genes. Primary endpoints include safety and tolerability (evaluation of dose-limiting toxicities and determining the maximum tolerated dose, maximum achievable dose, and RDE). Secondary endpoints include evaluation of the pharmacokinetic parameters of IMP1734 and measures of efficacy, including overall response rate, duration of response, progression-free survival, and overall survival. Exploratory endpoints include analysis of pharmacodynamic biomarkers, serial ctDNA measurements, and patient quality-of-life measures. This study opened on 11 Dec 2023. Clinical trial information: NCT06253130 .

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

15 Jun 2022·Cancer Research

Abstract 1051: Combination of senaparib with temozolomide for the treatment of cancer

Author: Hsieh, Chih-Yi ; Liu, Lan ; Zhou, Ruiyu ; Tian, Ye Edward ; Ma, Jie ; Cai, Sui Xiong ; Wang, Xiaozhu ; Ma, Ning ; Guo, Mingchuan

AbstractPoly (ADP-ribose) polymerase (PARP) is a critical enzyme for DNA repair and PARP inhibitors have been found to be efficacious against cancers with defects in DNA repair pathways such as with BRCA mutations. In addition, in vitro and in vivo studies have found that for PARP inhibitors with good trapping activity, combination with temozolomide (TMZ) produced the best synergetic effects among different types of chemotherapies. Several clinical combination studies of PARP inhibitors with TMZ have been reported, such as the combination of olaparib with TMZ in small cell lung cancer (SCLC). In this presentation, we will report in vitro and in vivo studies of PARP inhibitor senaparib (IMP4297) in combination with TMZ. Synergetic effects were observed when senaparib was combined with TMZ in vitro against human SCLC NCI-H209 cells. In vivo studies of high-dose senaparib in combination with low-dose TMZ once a day continuously in human SCLC NCI-H209 xenograft model was found to be highly synergetic and well tolerated. A clinical study of senaparib in combination with TMZ in patients with advanced solid tumors and SCLC is ongoing (ClinicalTrials.gov Identifier: NCT04434482).Citation Format: Sui Xiong Cai, Ning Ma, Xiaozhu Wang, Jie Ma, Mingchuan Guo, Ruiyu Zhou, Lan Liu, Chih-Yi Hsieh, Ye Edward Tian. Combination of senaparib with temozolomide for the treatment of cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 1051.

100 Deals associated with IMPACT Therapeutics, Inc.

100 Translational Medicine associated with IMPACT Therapeutics, Inc.

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Pipeline Snapshot as of 07 Nov 2024

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

IMP-1734 ( PARP1 )	Advanced Malignant Solid Neoplasm More	Phase 2 Clinical
IMP-9064 ( ATR )	Solid tumor More	IND Approval
USP1 inhibitor(Shanghai Impact) ( USP1 )	Neoplasms More	Discovery
Senaparib ( PARP1 x PARP2 )	Solid tumor More	Pending

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