Actively Recruiting
Study of SHR-3276 Injection to Assess Safety, Tolerability, Pharmacokinetics, and Effects in Patients With Advanced Malignant Tumors
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-01-08
115
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an open-label, multicenter Phase I/II clinical trial to study the safety, tolerability, pharmacokinetics, and effectiveness of SHR-3276 injection in patients with advanced solid tumors. The study focuses on patients who have advanced malignant tumors that have either failed standard treatments or lack effective standard treatment options. The treatment involves intravenous administration of SHR-3276 with a dose escalation phase that includes four preset dose levels. Following this, a dose expansion stage will select two to three dose cohorts for further evaluation. Additionally, an indication expansion phase will assess preliminary effectiveness in selected tumor types. Participants will be monitored for up to three years for adverse events, with primary outcomes including incidence and severity of side effects. The study will also determine the maximum tolerated dose over six months and the recommended dose for further studies within one year. Assessments will include regular evaluations of safety, treatment effects, and pharmacokinetics throughout the study period.
CONDITIONS
Official 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 18-70 years old (both male and female)
- Pathologically confirmed advanced malignant tumors with failed or no effective standard treatment
- Presence of measurable lesions
- ECOG performance status 0-1
- Expected survival of at least 12 weeks
- Major organs functioning within required limits
- Fertile females must have a negative serum pregnancy test within 7 days before first dose and must not be breastfeeding
You will not qualify if you...
- Symptomatic central nervous system or meningeal metastases
- Untreated spinal cord compression by surgery or radiotherapy
- Uncontrolled tumor-related pain
- Uncontrolled third space effusions (pleural, pericardial, or peritoneal)
- Systemic antitumor therapy within 28 days prior to first treatment
- Surgery requiring general anesthesia within 28 days prior to first treatment or planned during study
- Serious adverse reactions from prior immune checkpoint inhibitor therapy
- Unresolved toxicities from previous anticancer treatment above grade 1
- Use of live attenuated vaccines within 28 days before or during treatment
- Systemic immunosuppressive therapy within 14 days before first treatment
- Arterial or venous thrombosis within 3 months before first treatment
- Clinically significant lung disease
- History of autoimmune diseases
- Other malignancies within 5 years before treatment
- Known severe allergies to the investigational drug or its ingredients
- History of immune deficiency or organ transplantation
- Other serious illnesses that may compromise treatment safety
AI-Screening
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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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