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.
Voluntarily sign the informed consent form and follow protocol requirements;
Aged 18 to 75 (both inclusive), male or female, regardless of race;
Expected survival period ≥ 12 weeks;
ECOG PS score ≤1;
Radically cured basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ, or breast cancer in situ;
Second primary cancer that has been cured with no recurrence within 5 years;
Patients who are allergic to any component of the study drug or have a history of severe allergies;
Major surgery or major trauma occurred within 4 weeks before the first study drug, but diagnostic tissue biopsies are allowed. Severe trauma refers to unhealed wounds, ulcers, or fractures;
Single group
CSCJC3456 tablet
Drug* 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.
Phase Ia: Dose Limiting Toxicity (DLT)
Number and proportion of individuals experiencing DLT. According to the NCI-CTCAE V5.0 toxicity evaluation criteria, DLT is defined as a certain level of toxicity related to the study drug (including definitely related, probably related, and possibly related) occurring during the first treatment cycle (C0D1\~C1D21) of single and multiple administrations.
Phase Ia: Maximum Tolerated Dose (MTD)
MTD is defined as the maximum dose at which the number of cases with DLT is ≤1/6 during the DLT observation period. To determine MTD, 6 evaluable participants are required.
Phase Ia: Assessment of safety and toxicity profile
Number of participants who experienced AEs, SAEs, and changes in physical examination, vital signs, ECOG score, imaging examination, laboratory tests, and 12-lead electrocardiogram, etc.
Phase Ib: Objective Response Rate (ORR)
ORR is defined as the proportion of participants whose tumors have achieved complete response (CR) and partial response (PR) after treatment, with response confirmed at least 4 weeks after the first assessment of CR or PR.
Phase Ia and Phase Ib: Terminal Phase Half-life (t1/2 )
Evaluate drug concentration-time data by individual subject for single or repeated dosing of CSCJC3456.
Phase Ia and Phase Ib: Maximum plasma concentration (Cmax)
Evaluate drug concentration-time data by individual subject for single or repeated dosing of CSCJC3456.
Phase Ia and Phase Ib: Time to reach Cmax (tmax)
Evaluate drug concentration-time data by individual subject for single or repeated dosing of CSCJC3456.
Phase Ia and Phase Ib: Area Under the Curve (AUC)
Evaluate drug concentration-time data by individual subject for single or repeated dosing of CSCJC3456.
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