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RECRUITING
NCT05773820
PHASE1/PHASE2

A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors

Sponsor: Wigen Biomedicine Technology (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of WJB001 Capsules in Dose Escalation, Dose Expansion, and Efficacy Expansion in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2023-05-05

Completion Date

2027-05-23

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

DRUG

WJB001

WJB001 Capsules:160mg(or othe dosages),Oral,QD,Days 1-5, 8-12, 15-19 or other dosing frequencies,Every 21 days

Locations (11)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Tumor Hospital Affiliated to Guangxi Medical University

Nanning, Guangxi, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Fuxin People's Hospital (Fuxin Women and Children's Medical Center)

Fuxin, Liaoning, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi’an, Shanxi, China

Henan Cancer Hospital

Henan, Zhenzhou, China