[Translation] Phase II clinical study of the efficacy, safety, tolerability and pharmacokinetics of FDA022-BB05 in patients with advanced solid tumors

评估FDA022-BB05在多种晚期实体瘤患者中的安全性和耐受性；初步评估FDA022-BB05在多种晚期实体瘤患者中的抗肿瘤疗效（应用实体瘤疗效评价标准（RECIST 1.1））；应用实体瘤疗效评价标准（RECIST 1.1）评估FDA022-BB05在晚期实体瘤患者中的疗效；评估FDA022-BB05在晚期实体瘤患者中的免疫原性；评价FDA022-BB05在晚期实体瘤患者中的药代动力学（PK）特征；探索肿瘤组织中HER2表达水平与抗肿瘤疗效的关系。

[Translation]

To evaluate the safety and tolerability of FDA022-BB05 in patients with various advanced solid tumors; to preliminarily evaluate the anti-tumor efficacy of FDA022-BB05 in patients with various advanced solid tumors (using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)); to evaluate the efficacy of FDA022-BB05 in patients with advanced solid tumors using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1); to evaluate the immunogenicity of FDA022-BB05 in patients with advanced solid tumors; to evaluate the pharmacokinetic (PK) characteristics of FDA022-BB05 in patients with advanced solid tumors; and to explore the relationship between HER2 expression levels in tumor tissues and anti-tumor efficacy.

Start Date05 Jun 2024

Sponsor / Collaborator

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

NCT06413615 / RecruitingPhase 2

A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of FDA022-BB05 in Patients with Advanced/Metastatic Solid Tumors

This is an open-label, multicenter, Phase II study to evaluate the efficacy and safety of FDA022-BB05 for the treatment in locally advanced, unresectable, or metastatic patients with selected HER2 overexpressing/expressing solid tumors which are not eligible for curative therapy.

Start Date13 May 2024

Sponsor / Collaborator

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

NCT05564858 / RecruitingPhase 1

A PhaseⅠStudy to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of FDA022-BB05 in Subjects With Advanced Solid Malignant Tumors

This is a Phase 1, open-label and two-part study to evaluate the safety, tolerability, pharmacokinetics and efficacy of FDA022-BB05 in participants with advanced/metastatic solid malignant tumors.

Start Date16 Jan 2023

Sponsor / Collaborator

Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.

100 Clinical Results associated with FDA022

100 Translational Medicine associated with FDA022

100 Patents (Medical) associated with FDA022

Literatures (Medical) associated with FDA022

Journal of Medicinal Chemistry

Evaluation of Double Self-Immolative Linker-Based Antibody–Drug Conjugate FDA022-BB05 with Enhanced Therapeutic Potential

Article

Author: Zhang, Yifan ; Cheng, Zhiyang ; Zhang, Wenbo ; Liu, Shuangxi ; Wang, Baoxia ; Wu, Yinghan ; Wu, Jingsong ; Xie, Qian ; Song, Ruiwen ; Qiu, Xuefei ; Gao, Bei ; Guo, Qingsong ; Cao, Xuemei ; Zhao, Teng ; Yin, Sicheng ; Xu, Jun ; Li, Weinan ; Yang, Tong ; Lu, Wei ; Shen, Keyu ; Wang, Lei ; Zhu, Shulei

Typical antibody-drug conjugates (ADCs) with valine-alanine linkage, often conjugated with the amino group in payloads, face challenges when interacting with hydroxyl group-containing payloads. Herein, we introduced a transformative Val-Ala-based double self-immolative linker-payload platform, reshaping ADCs by optimizing hydroxyl group-containing payload integration. Utilizing this platform, FDA022-BB05 was successfully conjugated with the hydroxyl group-containing payload DXd using trastuzumab (FDA022) as the monoclonal antibody (mAb). FDA022-BB05 demonstrated enhanced stability, effective cathepsin B sensitivity, reduced cell proliferation, increased bystander killing, and targeted delivery. Notably, acute toxicity evaluations in diverse preclinical models indicated favorable safety profiles and tolerability, with a broad therapeutic index in HER2-positive and -negative xenografts. Overall, these compelling findings support the promising therapeutic potential of FDA022-BB05, emphasizing the significance of diverse linker-payload platform strategies. This ADC is a valuable addition to targeted cancer therapy development, currently advancing through phase I clinical trials.

100 Deals associated with FDA022

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 2	CN	Shanghai Fudan Zhangjiang Bio Pharmaceutical Co., Ltd.	13 May 2024

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