RecruitingPhase 1NCT06717750

A Study of CSCJC3456 in Patients With Advanced Malignant Tumors

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

Sponsor

Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd.

Enrollment

102 participants

Start Date

Feb 13, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced malignant solid tumors

Summary

This is a multicenter, open-label, phase I clinical study employing a dose-escalation and cohort-expansion design to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of CSCJC3456 in patients with advanced malignant solid tumors.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CSCJC3456 tablet for people with advanced malignant solid tumors. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCSCJC3456 tablet

* Phase Ia: Single and Multiple Dose Escalation. Oral administration, 5-540 mg/day, once or twice daily (QD or BID). Treatment may be given continuously or intermittently as 3 weeks on/1 week off (28-day cycle) or 2 weeks on/1 week off (21-day cycle). * Phase Ib: Cohort Expansion. The dosage and dosing regimen will follow the recommended dose and dosing schedule derived from the Phase Ia study.