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Study identifier: NCT05773820 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors

Condition: Advanced Solid Tumors  ·  Sponsor: Wigen Biomedicine Technology (Shanghai) Co., Ltd.

PhasePhase 1/Phase 2
Planned participants210
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

This is a phase I/II study to evaluate the safety and tolerability, DLT(Dose limited toxicity), MTD(Maximum tolerated dose), and RP2D(Recommended phase II dose) of WJB001 capsules in patients with advanced solid tumors, including dose escalation phase, dose expansion phase and cohort expansion phase.The study includes screening, treatment and follow-up periods. In the Dose Escalation phase:Accelerated titration (the first two dose groups) and "BOIN" combination (the subsequent dose group) were used for dose escalation. In the Dose Expansion phase:Based on the previous data, 1 to 2 doses were selected to further evaluate the initial efficacy, safety, tolerability and pharmacokinetic characteristics to confirm RP2D. In the Efficacy Expansion phase:The preliminary plan of Efficacy expansion phase uses the Simon two-stage optimal method to expand 2 to 3 cohorts.

This description comes directly from the study's public registry record.

Talk to the study team

Yirong Zhao, Medical Director  ·  86 15221069447  ·  yrzhao@wigenbio.com

Always discuss trial participation with your own doctor first.

Locations (11)

Cancer Hospital Chinese Academy of Medical SciencesBeijing, Beijing Municipality, ChinaRecruiting
Fujian Cancer HospitalFuzhou, Fujian, ChinaRecruiting
Sun Yat-sen University Cancer CenterGuangzhou, Guangdong, ChinaRecruiting
Tumor Hospital Affiliated to Guangxi Medical UniversityNanning, Guangxi, ChinaRecruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, Hubei, ChinaRecruiting
Hunan Cancer HospitalChangsha, Hunan, ChinaRecruiting
Fuxin People's Hospital (Fuxin Women and Children's Medical Center)Fuxin, Liaoning, ChinaNot Yet Recruiting
Liaoning Cancer HospitalShenyang, Liaoning, ChinaRecruiting
Shanxi Cancer HospitalTaiyuan, Shanxi, ChinaRecruiting
The First Affiliated Hospital of Xi 'an Jiaotong UniversityXi’an, Shanxi, ChinaRecruiting
Henan Cancer HospitalHenan, Zhenzhou, ChinaRecruiting

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