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

Phase 1

Not yet recruiting

• Conditions: Advanced Malignant Tumors
• Interventions: Drug: SPGL008

• Registration Number: NCT07038005
• Lead Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

Brief Summary

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

Detailed Description

This study is a study of SPGL-008 monotherapy in patients with advanced malignant tumors. The study includes two cohorts, Cohort 1 and Cohort 2 will be administered by intravenous and subcutaneous administration respectively. Both cohorts will be conducted by the dose-escalation design to evaluate safety, tolerability and preliminary efficacy of different administration of SPGL008.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-07-13
• Primary Completion: 2026-09-22
• Study Completion: 2027-06-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Males and/or females, 18-75 years old;
2. Histologically and/or cytologically documented advanced or metastatic malignant Tumors;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
4. Expected survival >=3 months;
5. Signed informed consent form.

Exclusion Criteria

1. Known uncontrolled or symptomatic central nervous system metastatic disease;
2. 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);
3. Inadequate organ or bone marrow function;
4. Pregnant or breast-feeding woman;
5. Known allergies, hypersensitivity, or intolerance to SPGL008.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dose level 1 of SPGL008 （Intravenous administration）	SPGL008	-
dose level 2 of SPGL008 （Intravenous administration）	SPGL008	-
dose level 3 of SPGL008 （Intravenous administration）	SPGL008	-
dose level 4 of SPGL008 （Intravenous administration）	SPGL008	-
dose level 5 of SPGL008 （Intravenous administration）	SPGL008	-
dose level 6 of SPGL008 （Intravenous administration）	SPGL008	-
dose level 7 of SPGL008 （Intravenous administration）	SPGL008	-
dose level 8 of SPGL008 （Intravenous administration）	SPGL008	-
dose level 1 of SPGL008 （Subcutaneous administration）	SPGL008	-
dose level 2 of SPGL008 （Subcutaneous administration）	SPGL008	-
dose level 3 of SPGL008 （Subcutaneous administration）	SPGL008	-
dose level 4 of SPGL008 （Subcutaneous administration）	SPGL008	-
dose level 5 of SPGL008 （Subcutaneous administration）	SPGL008	-
dose level 6 of SPGL008 （Subcutaneous administration）	SPGL008	-

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity (DLT)	During the first cycle. Each cycle is 21 days	DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(21 days) of treatment.
Maximum tolerated dose (MTD)	During the first cycle. Each cycle is 21 days	MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.

Secondary Outcome Measures

Name	Time	Method
Cmax	Up to 2 years
Tmax	Up to 2 years
T1/2	Up to 2 years
AUC	Up to 2 years
Objective Response Rate (ORR)	Up to 2 years	Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.