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SPGL008 Monotherapy for Advanced Malignant Tumors Treatment

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Study Aim

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.

What is being tested

SPGL008

Drug
Who is being recruted

From 18 to 75 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorShenyang Sunshine Pharmaceutical Co., LTD.
Study Contactyongsheng Li
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SPGL008 Monotherapy for Patients With Advanced Malignant Tumors
NCT07038005
Principal SponsorShenyang Sunshine Pharmaceutical Co., LTD.
Study Contactyongsheng Li
Last updated: February 10, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

96 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

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

5 inclusion criteria required to participate
Males and/or females, 18-75 years old;

Histologically and/or cytologically documented advanced or metastatic malignant Tumors;

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

Expected survival >=3 months;

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5 exclusion criteria prevent from participating
Known uncontrolled or symptomatic central nervous system metastatic disease;

Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI-CTCAE] v.5.0);

Inadequate organ or bone marrow function;

Pregnant or breast-feeding woman;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

14 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Group 5

Experimental

Group 6

Experimental

Group 7

Experimental

Group 8

Experimental

Group 9

Experimental

Group 10

Experimental

Group 11

Experimental

Group 12

Experimental

Group 13

Experimental

Group 14

Experimental

Study 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

Recruiting

Chongqing University Cancer Hospital

Chongqing, ChinaOpen Chongqing University Cancer Hospital in Google Maps
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One Study Center