SPGL008 Monotherapy for Advanced Malignant Tumors Treatment
This study aims to determine the safe dosage and side effects of a new treatment for advanced malignant tumors, called SPGL008 monotherapy, in adult patients.
SPGL008
Treatment Study
Summary
Study start date: July 30, 2025
Actual date on which the first participant was enrolled.This study focuses on testing a new treatment called SPGL-008 for patients with advanced malignant tumors. Malignant tumors are a form of cancer that can spread to other parts of the body. The goal is to find out if SPGL-008 is safe and can be tolerated by patients, as well as to see if it shows any early signs of effectiveness against the tumors. This study is important because it could lead to new treatment options for patients with these severe forms of cancer, who often have limited choices. Participants in the study are divided into two groups. One group receives SPGL-008 through a vein, which is called intravenous administration, while the other group receives it under the skin, known as subcutaneous administration. The study uses a method called dose-escalation, meaning the amount of SPGL-008 given is gradually increased to determine the safest and most effective dose. Researchers will closely monitor participants to assess how well they tolerate the medication and to observe any potential benefits or side effects. The results from this study will help understand if SPGL-008 could be a viable treatment option in the future.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.96 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.14 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalGroup 5
ExperimentalGroup 6
ExperimentalGroup 7
ExperimentalGroup 8
ExperimentalGroup 9
ExperimentalGroup 10
ExperimentalGroup 11
ExperimentalGroup 12
ExperimentalGroup 13
ExperimentalGroup 14
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Chongqing University Cancer Hospital
Chongqing, ChinaOpen Chongqing University Cancer Hospital in Google Maps