Ignite Creation Date:
2025-12-24 @ 5:13 PM
Ignite Modification Date:
2025-12-24 @ 5:13 PM
Study NCT ID:
NCT06717750
Status:
RECRUITING
Last Update Posted:
2025-06-25
First Post:
2024-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of CSCJC3456 in Patients With Advanced Malignant Tumors
Sponsor:
Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd.
Organization:
Study Overview
Official Title:
A Single-arm, Open-label, Single/Multiple-dose Escalation, and Cohort Expansion Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Oral CSCJC3456 Tablets in Patients With Advanced Malignant Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a multicenter, open phase I clinical study of dose escalation, cohort expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of CSCJC3456 in patients with advanced malignant solid tumors.
Detailed Description:
CSCJC3456 is a multi-target tyrosine kinase inhibitor, and this is the first-in-human trial of CSCJC3456. This study adopts an open-label, non-randomized, single-arm, dose-escalation, and cohort expansion research design, and is divided into two parts, Phase Ia and Phase Ib.
Phase Ia is a single and multiple dose escalation trial with an open-label design, aiming to evaluate the safety, tolerability, PK, and PD characteristics of CSCJC3456 tablets, preliminarily assess the anti-tumor efficacy, and recommend the dose for Phase Ib study.
Phase Ib is a single-arm cohort expansion study conducted in participants with four target solid tumors, based on the recommended dosage and dosing cycle from the Phase Ia study. The actual tumor types for the Phase Ib study will be adjusted according to the safety and efficacy data from the Phase Ia study.
Phase Ia is a single and multiple dose escalation trial with an open-label design, aiming to evaluate the safety, tolerability, PK, and PD characteristics of CSCJC3456 tablets, preliminarily assess the anti-tumor efficacy, and recommend the dose for Phase Ib study.
Phase Ib is a single-arm cohort expansion study conducted in participants with four target solid tumors, based on the recommended dosage and dosing cycle from the Phase Ia study. The actual tumor types for the Phase Ib study will be adjusted according to the safety and efficacy data from the Phase Ia study.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: