NCT05470933

A Study Explore WJ01075 Tablets in Patients With Advanced Solid Tumors

A Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of WJ01075 Tablets in Oral Dose Escalation and Expansion in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Suzhou Junjing BioSciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I study to Investigate the safety and tolerability, DLT(Dose limited toxicity), MTD(Maximum tolerated dose), and RP2D(Recommended phase II dose) of WJ01075 tablets in patients with advanced malignant solid tumors, including phase Ia (dose escalation phase) and Phase Ib (dose expansion phase,cohort expansion phase).The study includes screening, treatment and follow-up periods. In phase Ia, accelerated titration (the first two dose groups) and "3 + 3" combination (the subsequent dose group) were used for dose escalation. In phase Ib, specific dose groups will be selected for dose expansion according to PK(Pharmacokinetics) and safety data of different dose groups in dose escalation phase.It is planned that SMC(Safety Monitoring Committee) will select one or more dose groups based on previous data for cohort expansion studies to further determine RP2D, safety tolerability and initial efficacy.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	WJ01075	Phase Ia: Dose Escalation Accelerated titration (the first two dose groups) and "3 + 3" combination (the subsequent dose group) were used for dose escalation. Phase Ib: Dose Expansion and Cohort Expansion The actual dose, dosing schedule (including combination) and indication selection will be evaluated based on the results of existing trials.

Timeline

• Start date: 2022-08-23
• Primary completion: 2023-04-18
• Completion: 2023-04-18
• First posted: 2022-07-22
• Last updated: 2023-09-01

Locations

1 site across 1 country: China