A Clinical Study of SHR-3276 for Injection in Patients With Advanced Malignant Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors

In brief

This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3276 for injection in patients with advanced solid tumors.

Key facts

Study ID

NCT06643754

Run by

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

People needed

115

Starts

2024-12-10

Expected to finish

2028-12-30

Last updated by the study team

2025-01-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able and willing to sign a written informed consent；
• Age 18-70 years old (including both ends), both male and female；
• Pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan；
• Existence of measurable lesions；
• ECOG score: 0-1；
• Expected survival time ≥ 12 weeks；
• The functional level of the major organs must meet the requirements；
• Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating.

You may not qualify if…

• Central nervous system metastasis or meningeal metastasis with clinical symptoms;
• Spinal cord compression that has not been treated radically by surgery and/or radiotherapy；
• Patients with uncontrolled tumor-related pain as judged by the investigator
• A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator；
• Systemic antitumor therapy was administered within 28 days prior to treatment in the first study；
• Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, or elective surgery was expected during the trial period；
• Serious drug-related adverse reactions during previous immune checkpoint inhibitor therapy；
• Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1；
• Live attenuated vaccines were used within 28 days prior to administration in the first study or were expected to be required during the study treatment；
• Systemic immunosuppressive therapy was administered within 14 days prior to the first study
• Arterial/venous thrombosis events occurred within 3 months prior to initial administration
• Patients with clinical significant lung disease;
• Patients with history of autoimmune diseases;
• The first study studied any other malignancy within 5 years prior to medication
• A known history of severe allergic reactions to the investigational drug and its principal formulation ingredients；
• Have a history of immune deficiency or organ transplantation；
• Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.

Where it is running

• The Second Affiliated Hospital of PLA Army Medical University — Chongqing, Chongqing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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