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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2027-06-08

Brief Summary

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

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Detailed Description

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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.

Conditions

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Advanced Malignant Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dose level 5 of SPGL008 （Intravenous administration）

Group Type EXPERIMENTAL

SPGL008

Intervention Type DRUG

Biological product

dose level 6 of SPGL008 （Intravenous administration）

Group Type EXPERIMENTAL

SPGL008

Intervention Type DRUG

Biological product

dose level 7 of SPGL008 （Intravenous administration）

Group Type EXPERIMENTAL

SPGL008

Intervention Type DRUG

Biological product

dose level 8 of SPGL008 （Intravenous administration）

Group Type EXPERIMENTAL

SPGL008

Intervention Type DRUG

Biological product

dose level 1 of SPGL008 （Subcutaneous administration）

Group Type EXPERIMENTAL

SPGL008

Intervention Type DRUG

Biological product

dose level 2 of SPGL008 （Subcutaneous administration）

Group Type EXPERIMENTAL

SPGL008

Intervention Type DRUG

Biological product

dose level 3 of SPGL008 （Subcutaneous administration）

Group Type EXPERIMENTAL

SPGL008

Intervention Type DRUG

Biological product

dose level 4 of SPGL008 （Subcutaneous administration）

Group Type EXPERIMENTAL

SPGL008

Intervention Type DRUG

Biological product

dose level 5 of SPGL008 （Subcutaneous administration）

Group Type EXPERIMENTAL

SPGL008

Intervention Type DRUG

Biological product

dose level 6 of SPGL008 （Subcutaneous administration）

Group Type EXPERIMENTAL

SPGL008

Intervention Type DRUG

Biological product

dose level 4 of SPGL008 （Intravenous administration）

Group Type EXPERIMENTAL

SPGL008

Intervention Type DRUG

Biological product

dose level 1 of SPGL008 （Intravenous administration）

Group Type EXPERIMENTAL

SPGL008

Intervention Type DRUG

Biological product

dose level 2 of SPGL008 （Intravenous administration）

Group Type EXPERIMENTAL

SPGL008

Intervention Type DRUG

Biological product

dose level 3 of SPGL008 （Intravenous administration）

Group Type EXPERIMENTAL

SPGL008

Intervention Type DRUG

Biological product

Interventions

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SPGL008

Biological product

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No