A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LP-108, a BCL-2 Inhibitor, Combined With Azacitidine In Subjects With AML, MDS, CMML

This is a Phase 1, open-label, multicenter, dose-escalation & expansion study to evaluate the safety,tolerability and pharmacokinetics (PK) of LP-108, a BCL-2 inhibitor, combined with azacitidine, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RP2D), and to assess the preliminary efficacy of this combination.

Start Date14 Feb 2023

Sponsor / Collaborator

Guangzhou Lupeng Pharmaceutical Co., Ltd.

CTR20223053 / RecruitingPhase 1

一项评估口服BCL-2抑制剂LP-108联合阿扎胞苷治疗急性髓系白血病（AML）、骨髓增生异常综合征（MDS）或慢性粒-单核细胞白血病（CMML）患者的安全性、耐受性、药代动力学特征以及初步疗效的I期临床研究

[Translation] A Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of the oral BCL-2 inhibitor LP-108 combined with azacitidine in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)

评估口服BCL-2抑制剂LP-108联合阿扎胞苷治疗急性髓系白血病（AML）、骨髓增生异常综合征（MDS）或慢性粒-单核细胞白血病（CMML）患者的安全性、耐受性、药代动力学特征以及初步疗效。

[Translation]

To evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of the oral BCL-2 inhibitor LP-108 combined with azacitidine in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).

Start Date07 Feb 2023

Sponsor / Collaborator

Guangzhou Lupeng Pharmaceutical Co., Ltd.

NCT04139434 / Active, not recruitingPhase 1

A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination With Azacitidine in Subjects With Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)

A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination with Azacitidine in Subjects with Relapsed or Refractory Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)

Start Date06 Jul 2020

Sponsor / Collaborator

Newave Pharmaceutical Inc.

100 Clinical Results associated with Lacutoclax

100 Translational Medicine associated with Lacutoclax

100 Patents (Medical) associated with Lacutoclax

Literatures (Medical) associated with Lacutoclax

01 Jan 2012·Faraday DiscussionsQ2 · CHEMISTRY

Anticorrosion imidazolium ionic liquids as the additive in poly(ethylene glycol) for steel/Cu–Sn alloy contacts

Q2 · CHEMISTRY

Article

Author: Yongmin Liang ; Meirong Cai ; Weimin Liu ; Feng Zhou

3-((1H-benzo[d][1,2,3]triazol-1-yl)methyl)-1-methyl-1H-imidazolium hexafluorophosphates ([BTAMIM][PF6]) ionic liquids (ILs) were evaluated as friction reduction, antiwear (AW) and anticorrosion additives in poly(ethylene glycol) (PEG) for steel/Cu-Sn alloy contacts at 100 degrees C. The physical properties of PEG with the additive were measured. The anticorrosion properties of [BTAMIM][PF6] was assessed via the accelerated corrosion test, which reveals the excellent anticorrosion properties in comparison with selected conventional ILs that have no benzotriazole group. Tribological results indicated that [BTAMIM][PF6] as additives could effectively reduce the friction and wear of sliding pairs in PEG. The tribological properties were generally better than the normally used dibutyl phosphite (T304) and conventional ILs L-P108 in PEG. The wear mechanisms are tentatively discussed according to the morphology observation of worn surfaces of Cu-Sn alloy discs by scanning electron microscopy (SEM) and surface composition analysis by X-ray photoelectron spectroscopy (XPS), which revealed complex tribochemical reactions during the sliding process leading to a surface protective film composed of [Cu(-C6H5N3-R)], Cu20, CuF2 and C-O bond containing compound is formed. A strong interaction between benzotriazole and the surface of the Cu alloy was proposed to account for the excellent friction reduction, anti-wear and anti-corrosion capability improvement.

100 Deals associated with Lacutoclax

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Lymphocytic Leukemia	Phase 2	CN	Guangzhou Lupeng Pharmaceutical Co., Ltd.	-
Small Lymphocytic Lymphoma	Phase 2	CN	Guangzhou Lupeng Pharmaceutical Co., Ltd.	-
Acute Myeloid Leukemia	Phase 1	CN	Guangzhou Lupeng Pharmaceutical Co., Ltd.	06 Jul 2020
Adult Acute Myeloblastic Leukemia	Phase 1	US	Newave Pharmaceutical Inc.	06 Jul 2020
Adult Acute Myeloblastic Leukemia	Phase 1	ES	Newave Pharmaceutical Inc.	06 Jul 2020
Refractory Adult Acute Lymphoblastic Leukemia	Phase 1	US	Newave Pharmaceutical Inc.	06 Jul 2020
Refractory Adult Acute Lymphoblastic Leukemia	Phase 1	ES	Newave Pharmaceutical Inc.	06 Jul 2020
Relapsing acute myeloid leukemia	Phase 1	ES	Newave Pharmaceutical Inc.	06 Jul 2020
Relapsing acute myeloid leukemia	Phase 1	US	Newave Pharmaceutical Inc.	06 Jul 2020
B-Cell Lymphoma	Phase 1	CN	Guangzhou Lupeng Pharmaceutical Co., Ltd.	17 Jun 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04356846 (EHA2024) Manual	Phase 1	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma BTKi	33	LP-108	(ndmcardppk) = jfnkulilks pboesiqlsg (apeutuyusc ) View more	Positive	14 May 2024
NCT04139434 (EHA2023)	Phase 1	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	32	LP-108 monotherapy	(rzvgjkwlix) = acbcccifqs bveaasymun (qmupqkcuof ) View more	-	08 Jun 2023
NCT04139434 (EHA2023)	Phase 1	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	32	LP-108 combined with azacitidine	(rzvgjkwlix) = lhyjlmwlzt bveaasymun (qmupqkcuof ) View more	-	08 Jun 2023
NCT04356846 (EHA2023)	Phase 1	B-cell lymphoma refractory \| B-cell lymphoma recurrent	49	LP-108	dfsbfotfya(qvlssburtd) = kkyxpixqhe cmafzeurfh (hjrqrgzmxe ) View more	-	08 Jun 2023
NCT04356846 (EHA2022) Manual	Phase 1	B-cell lymphoma refractory	19	LP-108	(fcihbrxcmy) = uenmpcafxf vwzgdoyqac (psboucmsgl ) View more	Positive	12 May 2022

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