RecruitingPhase 1NCT07038005

A Phase I Study of SPGL008 in Subjects With Advanced Malignant Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SPGL008 Monotherapy for Patients With Advanced Malignant Tumors

Sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Enrollment

96 participants

Start Date

Jul 30, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Malignant Tumors

Summary

This study includes two cohorts, respectively evaluating safety, tolerability and preliminary efficacy of intravenous and subcutaneous administration of SPGL008.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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;
Signed informed consent form.

Exclusion Criteria5

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;
Known allergies, hypersensitivity, or intolerance to SPGL008.

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