A Study Explore WJB001 Capsules in Patients With Advanced Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: Advanced Solid Tumors
In brief
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.
Key facts
- Study ID
- NCT05773820
- Run by
- Wigen Biomedicine Technology (Shanghai) Co., Ltd.
- People needed
- 210
- Starts
- 2023-05-05
- Expected to finish
- 2027-05-23
- Last updated by the study team
- 2026-04-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Henan Cancer Hospital — Henan, Zhenzhou, China (enrolling)
- Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
- Tumor Hospital Affiliated to Guangxi Medical University — Nanning, Guangxi, China (enrolling)
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
- Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
- Liaoning Cancer Hospital — Shenyang, Liaoning, China (enrolling)
- Shanxi Cancer Hospital — Taiyuan, Shanxi, China (enrolling)
- The First Affiliated Hospital of Xi 'an Jiaotong University — Xi’an, Shanxi, China (enrolling)
- Fuxin People's Hospital (Fuxin Women and Children's Medical Center) — Fuxin, Liaoning, China
Full record on ClinicalTrials.gov
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