A Trial of SHR-3792 Injection in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-3792 Injection.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase Ⅰ, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-3792 in Patients With Advanced Solid Tumors
Overview
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-3792 injection monotherapy for patients with advanced solid tumors, and to explore the reasonable dosage of SHR-3792 injection monotherapy for patients with advanced solid tumors.
Interventions
- Drug SHR-3792 Injection
SHR-3792 injection.
Primary outcome measures
- Maximum tolerated dose (MTD) [Time frame: From the first dose of study medication up to 21 days.]
- Recommended phase Ⅱ dose (RP2D) [Time frame: From the first dose of study medication up to 21 days.]
- Incidence of dose limited toxicity (DLT) [Time frame: From the first dose of study medication up to 21 days.]
- Adverse events (AEs) [Time frame: Up to 24 weeks.]
- Serious adverse events (SAEs) [Time frame: Up to 24 weeks.]
Secondary outcome measures (1)
- Objective response rate (ORR) [Time frame: Up to 6 months.]
Eligibility criteria
Inclusion criteria
- Subjects with ability to understand and voluntarily agree to participate by giving written informed consent form for the study.
- Patients with unresectable recurrent or metastatic solid tumors.
- There is at least one lesion that could be measured.
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
- Adequate organ functions as defined.
- Life expectancy ≥ 3 months.
Exclusion criteria
- Patients with known active central nervous system (CNS) metastases.
- Subjects with other malignancy in five years before the first dose.
- Patients with tumor-related pain that cannot be controlled as determined.
- Patients with serious cardiovascular and cerebrovascular diseases.
- Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion.
- Patients with severe infections.
- History of immunodeficiency.
- History of autoimmune diseases.
- Active infection.
- Pregnant or nursing women.
- Known history of serious allergic reactions to the investigational product or its main ingredients.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shandong First Medical University Affiliated Cancer Hospital — Jinan
Identifiers
NCT: NCT06907628 · SHR-3792-101