[Translation] An open-label phase I clinical study of the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of WBC100 capsules in patients with relapsed or refractory acute myeloid leukemia

主要目的：评估WBC100胶囊在复发或难治性急性髓系白血病患者中的安全性和耐受性；并探索剂量限制性毒性（DLT）和最大耐受剂量（MTD），为II期临床试验推荐给药剂量（RP2D）的确定提供依据。次要目的：评价WBC100胶囊在复发或难治性急性髓系白血病患者中的药代动力学（PK）特征；评估WBC100胶囊在复发或难治性急性髓系白血病患者中的初步疗效。

[Translation]

Primary objective: To evaluate the safety and tolerability of WBC100 capsules in patients with relapsed or refractory acute myeloid leukemia; and to explore the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) to provide a basis for determining the recommended dose (RP2D) for Phase II clinical trials. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of WBC100 capsules in patients with relapsed or refractory acute myeloid leukemia; to evaluate the preliminary efficacy of WBC100 capsules in patients with relapsed or refractory acute myeloid leukemia.

Start Date-

Sponsor / Collaborator

Hangzhou Weiben Pharmaceutical Co. Ltd.

CTR20211600 / RecruitingPhase 1

WBC100胶囊在C-Myc阳性实体瘤患者中的安全性、耐受性、药代动力学特征以及初步疗效的开放、剂量递增的I期临床研究

[Translation] An open-label, dose-escalation phase I clinical study of the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of WBC100 capsules in patients with C-Myc-positive solid tumors

主要目的：评估WBC100胶囊在C-Myc阳性晚期实体瘤患者中的安全性和耐受性；确定WBC100胶囊在C-Myc阳性晚期实体瘤患者中的剂量限制性毒性（DLT）和最大耐受剂量（MTD）。次要目的：评价WBC100胶囊在C-Myc阳性晚期实体瘤患者中的药代和药效动力学特征；按照实体瘤疗效评价标准（RECIST v1.1），评估WBC100胶囊在C-Myc阳性胰腺癌患者中的初步抗肿瘤活性；探索II期推荐剂量（RP2D）。

[Translation]

Primary objectives: To evaluate the safety and tolerability of WBC100 capsules in patients with C-Myc-positive advanced solid tumors; To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of WBC100 capsules in patients with C-Myc-positive advanced solid tumors. Secondary objectives: To evaluate the pharmacokinetic and pharmacodynamic characteristics of WBC100 capsules in patients with C-Myc-positive advanced solid tumors; According to the solid tumor efficacy evaluation criteria (RECIST v1.1), to evaluate the preliminary anti-tumor activity of WBC100 capsules in patients with C-Myc-positive pancreatic cancer; To explore the recommended dose (RP2D) for Phase II.

Start Date17 Dec 2021

Sponsor / Collaborator

Hangzhou Weiben Pharmaceutical Co. Ltd.

NCT05100251 / RecruitingPhase 1IIT

An Open, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of WBC100 in Patients With Advanced Solid Tumor

This is a phase I clinical study of WBC100 in Patients with advanced solid tumor.

Start Date25 Oct 2021

Sponsor / Collaborator

Zhejiang University

100 Clinical Results associated with WBC100

100 Translational Medicine associated with WBC100

100 Patents (Medical) associated with WBC100

Literatures (Medical) associated with WBC100

01 Mar 2022·Advanced ScienceQ1 · MATERIALS SCIENCE

A Selective Small‐Molecule c‐Myc Degrader Potently Regresses Lethal c‐Myc Overexpressing Tumors

Q1 · MATERIALS SCIENCE

ArticleOA

Author: Li, Mengyuan ; Wu, Zhaoxing ; Zhang, Lei ; Gan, Xiaoxian ; Zhuang, Haifeng ; Li, Hongzhi ; Huang, Yu ; Xu, Ying ; Xu, Rongzhen ; Wu, Shuigao ; Wu, Bowen ; Wang, Ping ; Yu, Qingfeng ; Zhang, Xuzhao

AbstractMYC oncogene is involved in the majority of human cancers and is often associated with poor outcomes, rendering it an extraordinarily desirable target, but therapeutic targeting of c‐Myc protein has been a challenge for >30 years. Here, WBC100, a novel oral active molecule glue that selectively degrades c‐Myc protein over other proteins and potently kills c‐Myc overexpressing cancer cells is reported. WBC100 targets the nuclear localization signal 1 (NLS1)–Basic–nuclear localization signal 2 (NLS2) region of c‐Myc and induces c‐Myc protein degradation through ubiquitin E3 ligase CHIP mediated 26S proteasome pathway, leading to apoptosis of cancer cells. In vivo, WBC100 potently regresses multiple lethal c‐Myc overexpressing tumors such as acute myeloid leukemia, pancreatic, and gastric cancers with good tolerability in multiple xenograft mouse models. Identification of the NLS1–Basic–NLS2 region as a druggable pocket for targeting the “undruggable” c‐Myc protein and that single‐agent WBC100 potently regresses c‐Myc overexpressing tumors through selective c‐Myc proteolysis opens new perspectives for pharmacologically intervening c‐Myc in human cancers.

100 Deals associated with WBC100

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 1	CN	Hangzhou Weiben Pharmaceutical Co. Ltd.	30 Aug 2024
C-Myc positive Solid Tumors	Phase 1	CN	Hangzhou Weiben Pharmaceutical Co. Ltd.	17 Dec 2021
C-Myc positive High grade B-cell lymphoma	IND Approval	CN	Hangzhou Weiben Pharmaceutical Co. Ltd.	20 Nov 2023
Solid tumor	Discovery	CN	Hangzhou Weiben Pharmaceutical Co. Ltd.	10 Oct 2020

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