MedTrace Logo

A Study of CSCJC3456 in Patients With Advanced Malignant Tumors

NCT06717750 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-02-02

No results posted yet for this study

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.

Conditions

  • Advanced Malignant Solid Tumors

Interventions

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.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Ning Li, M.D. · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-13
Primary Completion
2027-06-30
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06717750 on ClinicalTrials.gov