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 TPD3310 in patients withadvanced 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.
Curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the breast.
Second primary cancer that has been cured with no recurrence within 5 years.
Subjects allergic to any component of the study drug or with a history of severe allergies.
Major surgery or severe trauma within 4 weeks before the first study drug administration (major surgery is defined as any invasive surgery involving extensive resection or opening of mesothelial barriers such as pleural cavity, peritoneal cavity, or meninges; however, tissue biopsy for diagnostic purposes is allowed. Severe trauma refers to unhealed wounds, ulcers, or fractures).
Single group
TPD3310 injection
Drug* Phase Ia: Single and Multiple Dose Escalation. (1) Dosage form: injection. (2) Dosage: 6 dose groups, 50 mg, 100 mg, 200 mg, 350 mg, 500 mg, 650 mg,.-Arms Assigned Interventions (3) Frequency: once weekly. (4) Duration: days 1-21; 28 days per cycle. * Phase Ib: Cohort Expansion. Dosage and dosing regimen: according to the recommended dosage and dosing cycle from the Phase Ia study.
Phase Ia: Dose-Limiting Toxicity (DLT)
Continuously monitor safety; record toxic events meeting predefined criteria (NCI-CTCAE V5.0 Grade 3/4 non-hematological toxicity, Grade 4 hematological toxicity \>7 days, etc.). Include subjects with ≥75% planned dose or withdrawal due to DLT; causality confirmed by investigators.
Phase Ia: Maximum Tolerated Dose (MTD)
Adopt accelerated titration + "3+3" design; calculate DLT incidence per dose group. MTD is the maximum dose with ≤1/6 DLT cases, requiring at least 6 evaluable subjects.
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)
Evaluate by contrast-enhanced CT/MRI (RECIST v1.1; mRECIST for hepatocellular carcinoma). ORR = proportion of subjects with CR+PR (first response confirmed after 4 weeks).
Phase Ia: Objective Response Rate (ORR)
Assessed in subjects with measurable lesions at baseline per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Proportion of subjects achieving CR or PR after treatment.
Phase Ia and Phase Ib: Disease Control Rate (DCR)
Assessed per RECIST v1.1. Proportion of subjects achieving CR, PR, or Stable Disease (SD) after treatment.
Phase Ia and Phase Ib: Duration of Response (DOR)
Time from the first documentation of objective response (CR/PR) to the first occurrence of disease progression or death from any cause.
Phase Ia and Phase Ib: Progression-Free Survival (PFS)
Time from the start of treatment to the first occurrence of disease progression or death from any cause.
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