Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 2:58 PM
Study NCT ID:
NCT05470933
Status:
TERMINATED
Last Update Posted:
2023-09-01
First Post:
2022-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Explore WJ01075 Tablets in Patients With Advanced Solid Tumors
Sponsor:
Suzhou Junjing BioSciences Co., Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminate the study and close the research center based on strategic changes in product development, unrelated to drug safety.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: