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

Shenyang Sunshine Pharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Advanced Malignant Tumors

Treatments: Drug: SPGL008

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07038005

SPGL008-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 14 patient groups

dose level 1 of SPGL008 （Intravenous administration）

Experimental group

Treatment:

Drug: SPGL008

dose level 2 of SPGL008 （Intravenous administration）

Experimental group

Treatment:

Drug: SPGL008

dose level 3 of SPGL008 （Intravenous administration）

Experimental group

Treatment:

Drug: SPGL008

dose level 4 of SPGL008 （Intravenous administration）

Experimental group

Treatment:

Drug: SPGL008

dose level 5 of SPGL008 （Intravenous administration）

Experimental group

Treatment:

Drug: SPGL008

dose level 6 of SPGL008 （Intravenous administration）

Experimental group

Treatment:

Drug: SPGL008

dose level 7 of SPGL008 （Intravenous administration）

Experimental group

Treatment:

Drug: SPGL008

dose level 8 of SPGL008 （Intravenous administration）

Experimental group

Treatment:

Drug: SPGL008

dose level 1 of SPGL008 （Subcutaneous administration）

Experimental group

Treatment:

Drug: SPGL008

dose level 2 of SPGL008 （Subcutaneous administration）

Experimental group

Treatment:

Drug: SPGL008

dose level 3 of SPGL008 （Subcutaneous administration）

Experimental group

Treatment:

Drug: SPGL008

dose level 4 of SPGL008 （Subcutaneous administration）

Experimental group

Treatment:

Drug: SPGL008

dose level 5 of SPGL008 （Subcutaneous administration）

Experimental group

Treatment:

Drug: SPGL008

dose level 6 of SPGL008 （Subcutaneous administration）

Experimental group

Treatment:

Drug: SPGL008