Phase I Clinical Trial on the Tolerability and Pharmacokinetics of Recombinant Humanized Anti-PD-L1 Monoclonal Antibody MSB2311 Injection in the Treatment of Patients With Advanced Solid Tumors

This is a first-in-human (FIH), open-label, Phase 1 dose-Escalation Study of MSB2311, a humanized anti-PD-L1 monoclonal antibody, in subjects with advanced solid tumors. Qualified subjects will be enrolled to receive their assigned dose regimen of MSB2311 until disease progression or intolerable toxicity, withdrawal of consent, or end of study, whichever occurs first. The maximum treatment duration is 2 years. During the study, subjects will be evaluated for safety and toxicity, PK/PD, immunogenicity and anti-tumor activity of MSB2311.

Start Date13 Aug 2018

Sponsor / Collaborator

Suzhou Chuangsheng Pharmaceutical Group Co., Ltd.

CTR20180925 / RecruitingPhase 1

重组人源化抗PD-L1单克隆抗体MSB2311注射液治疗晚期实体瘤患者耐受性及药代动力学I期临床试验

[Translation] Phase I clinical trial on the tolerability and pharmacokinetics of recombinant humanized anti-PD-L1 monoclonal antibody MSB2311 injection in patients with advanced solid tumors

Ia期为剂量递增阶段，主要评估安全性、耐受性，并确定MTD和RP2D。1b期为剂量扩展期，选择多种特定类型的晚期实体瘤包括淋巴瘤患者入组扩展队列，初步评价MSB2311注射液的抗肿瘤疗效，并进一步评估MSB2311注射液的安全性、耐受性、PK，和免疫原性，以及进一步探索药效学特征等

[Translation]

Phase Ia is a dose escalation phase, which mainly evaluates safety and tolerability and determines the MTD and RP2D. Phase 1b is a dose expansion phase, which selects patients with various specific types of advanced solid tumors, including lymphoma, to enroll in the expansion cohort to preliminarily evaluate the anti-tumor efficacy of MSB2311 injection, and further evaluate the safety, tolerability, PK, and immunogenicity of MSB2311 injection, as well as further explore the pharmacodynamic characteristics, etc.

Start Date13 Aug 2018

Sponsor / Collaborator

Suzhou Chuangsheng Pharmaceutical Group Co., Ltd.

NCT03463473 / CompletedPhase 1

First-in-human, Open-label, Phase 1 Dose-Escalation Study of MSB2311, A Humanized Anti-PD-L1 Monoclonal Antibody in Subjects With Advanced Solid Tumors

This is a phase I study to determine the safety and toxicity, PK/PD, immunogenicity, biomarkers, anti-tumor activity and establish a preliminary recommended Phase 2 dose (RP2D) in subjects with advanced solid tumors.

Start Date12 Apr 2018

Sponsor / Collaborator

Suzhou Chuangsheng Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with MSB-2311

100 Translational Medicine associated with MSB-2311

100 Patents (Medical) associated with MSB-2311

Literatures (Medical) associated with MSB-2311

01 Aug 2023·Cancer immunology, immunotherapy : CII

Phase I study of MSB2311, a novel pH-dependent anti-PD-L1 monoclonal antibody, treating patients with advanced solid tumors and lymphoma.

Article

Author: Shi, Michael ; Li, Jing ; Qi, Chuan ; Qian, Xueming ; Zhong, Haijun ; Zhang, Jian ; Hu, Xichun ; Gong, Jifang ; Wang, Jianming ; Shen, Lin ; Zhang, Qingyuan ; Li, Jian ; Yang, Lei ; Lu, Lingmin ; Yao, Zhenling ; Zhang, Qi ; Ji, Dongmei ; Yuan, Ying

MSB2311 is a novel pH-dependent humanized anti-programmed death-ligand 1 (PD-L1) monoclonal antibody. This phase I study primarily aimed to determine the maximum tolerated dose (MTD)/recommended phase 2 dose level (RP2D) of MSB2311 in patients with advanced solid tumors or lymphoma. MSB2311 was intravenously administered at 3, 10, and 20 mg/kg every 3 weeks (Q3W) and 10 mg/kg every 2 weeks (Q2W) using 3 + 3 design. During expansion phase, eligible patients with either PD-L1 overexpression, Epstein-Barr Virus positive, microsatellite instability high/mismatch repair deficient, or high tumor mutation burden tumors were treated at RP2D. A total of 37 Chinese patients were treated, including 31 with solid tumors and 6 lymphoma. No dose limiting toxicity was reported and MTD was not reached. The trial was expanded at 20 mg/kg Q3W or 10 mg/kg Q2W, both of which were determined as RP2D. Most common drug-related treatment-emergent adverse events were anemia (43.2%), aspartate aminotransferase increase (27.0%), proteinuria (21.6%), alanine aminotransferase increase and hypothyroidism (18.9% each), thyroid stimulating hormone increased and hyperglycemia (16.2% each). Out of 20 efficacy evaluable patients with biomarker positive solid tumors, 6 achieved confirmed partial response with the median duration of response of 11.0 months (95% CI 7.0-11.4) and 4 had stable disease, resulting an objective response rate of 30.0% (95% CI 11.9, 54.3) and disease control rate of 50.0% (95% CI 27.2, 72.8). One partial response was also observed among 6 patients with lymphoma. MSB2311 demonstrated a manageable safety profile and promising antitumor activity in patients with advanced solid tumors and lymphomas.

100 Deals associated with MSB-2311

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 2	CN	Suzhou Chuangsheng Pharmaceutical Group Co., Ltd.	-
Advanced Malignant Solid Neoplasm	Discovery	US	Suzhou Chuangsheng Pharmaceutical Group Co., Ltd.	12 Apr 2018

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04272944 (CSCO2021) Manual	Not Applicable	Advanced cancer \| \|	37	MSB2311	(klufimeysq) = ratguxmmeu leidvkjqvf (xbbsyhnwgk ) View more	Positive	25 Sep 2021
				MSB2311 (TMB-H)	(klufimeysq) = yhaftpypne leidvkjqvf (xbbsyhnwgk ) View more
NCT04272944 (ASCO2021)	Phase 1	Hematologic Neoplasms \| HR-positive/HER2-low Solid Tumors	33	MSB2311 10mg/kg Q2W	(fdanyvjwsy) = the most common AEs (>20%) included: anemia niwzogwnvl (juoyqalgzo ) View more	Positive	28 May 2021
				MSB2311 20mg/kg Q3W
ASCO2020	Phase 1	HR-positive/HER2-low Solid Tumors \| Hematologic Neoplasms	27	MSB2311 20mg/kg	(bzauifdoxq) = lcgdjekobj ubpukafvrf (udqonojdnl ) View more	Positive	25 May 2020

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