Actively Recruiting
A Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-3276 Injection in Patients With Advanced Malignant Tumors
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-01-08
115
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of SHR-3276 for injection in patients with advanced solid tumors that have not responded to standard treatments. This open-label, multicenter clinical trial is being conducted as a Phase I/II study to better understand how SHR-3276 works in this patient population. The study is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. and aims to gather detailed safety and efficacy data over several years. SHR-3276 is given through intravenous infusion at preset dose levels in a dose escalation stage. Following this, selected dose cohorts will enter a dose expansion phase to further evaluate the treatment. The study also includes an indication expansion period to assess preliminary efficacy in different tumor types. Patients will receive SHR-3276 according to the assigned dose level throughout the study. Participants will be monitored closely for adverse events for up to three years, with assessments including the maximum tolerated dose, recommended dose, and pharmacokinetic measurements like maximum concentration and time to maximum concentration. Researchers will also evaluate response rates, duration of response, disease control, progression-free survival, and overall survival. Safety will be tracked carefully, and participants are expected to be followed for at least three years to collect comprehensive data on treatment effects and tolerability.
CONDITIONS
Brief Title
A Clinical Study of SHR-3276 for Injection in Patients With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to sign a written informed consent
- Age 18 to 70 years old, both male and female
- Pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan
- Presence of measurable lesions
- ECOG performance status score of 0 or 1
- Expected survival time of 12 weeks or longer
- Functional level of major organs meets study requirements
- Fertile female patients must have a negative serum pregnancy test within 7 days before first medication and must not be lactating
You will not qualify if you...
- Central nervous system or meningeal metastasis with clinical symptoms
- Untreated spinal cord compression by surgery or radiotherapy
- Uncontrolled tumor-related pain
- Uncontrolled third space effusions such as pleural, pericardial, or peritoneal effusion
- Systemic antitumor therapy within 28 days prior to study treatment
- Recent surgery requiring general anesthesia within 28 days prior to study or planned elective surgery during the trial
- Serious adverse reactions from prior immune checkpoint inhibitor therapy
- Unresolved toxicities from previous anticancer therapy worse than grade 1
- Use of live attenuated vaccines within 28 days prior to study or expected during treatment
- Systemic immunosuppressive therapy within 14 days prior to study
- Arterial or venous thrombosis within 3 months prior to treatment
- Clinically significant lung disease
- History of autoimmune disease
- Diagnosis of any other malignancy within 5 years prior to study medication
- Known severe allergic reactions to the investigational drug or its ingredients
- History of immune deficiency or organ transplantation
- Other serious illnesses that could affect treatment safety according to investigator assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years or until disease progression or discontinuation
Participants receive intravenous SHR-3276 at assigned dose levels to evaluate safety, tolerability, pharmacokinetics, and efficacy.
Visits occur according to dosing and assessment schedule throughout treatment
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of PLA Army Medical University
Chongqing, Chongqing Municipality, China, 400037
Actively Recruiting
Research Team
Z
Zhenqun Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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