NCT06717750

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Changshan ConjuChem BioPharmaceutical Research and Development (Hebei) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	CSCJC3456 tablet	* 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.

Timeline

• Start date: 2025-02-13
• Primary completion: 2027-06-30
• Completion: 2028-06-30
• First posted: 2024-12-05
• Last updated: 2026-02-02

Locations

2 sites across 1 country: China