A Study of TPD3310 in Patients With Advanced Malignant Tumors

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTAIBIDI PHARMACEUTICAL TECHNOLOGY(SHIJIAZHUANG) CO.,LTD.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • TPD3310 injection

Treatment groups

112 Participants
are divided into 1 treatment group