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
Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd.
102 participants
Feb 13, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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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
* Phase Ia: Single and Multiple Dose Escalation. 1. Dosage form: tablet. 2. Dosage: 7 dose groups, 5 mg, 15 mg, 30 mg, 45 mg, 60 mg, 80 mg, 100 mg. 3. Frequency: once daily (tentative), or twice daily and other options (adjusted based on the results of the preliminary trials). 4. Duration: 5 mg(days 1-28; 28 days per cycle), other groups (days 1-14; 21 days per cycle) . * Phase Ib: Cohort Expansion. Dosage and dosing regimen: according to the recommended dosage and dosing cycle from the Phase Ia study.
Locations(2)
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NCT06717750