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

ConditionAdvanced Malignant Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenyang Sunshine Pharmaceutical Co., LTD.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • SPGL008

    Drug

    Biological product

Treatment groups

96 Participants
are divided into 14 treatment groups

14

Treatment groups

See each treatment group below.

Group A: dose level 1 of SPGL008 （Intravenous administration）Experimental treatment 1 intervention
Group B: dose level 2 of SPGL008 （Intravenous administration）Experimental treatment 1 intervention
Group C: dose level 3 of SPGL008 （Intravenous administration）Experimental treatment 1 intervention
Group D: dose level 4 of SPGL008 （Intravenous administration）Experimental treatment 1 intervention
Group E: dose level 5 of SPGL008 （Intravenous administration）Experimental treatment 1 intervention
Group F: dose level 6 of SPGL008 （Intravenous administration）Experimental treatment 1 intervention
Group G: dose level 7 of SPGL008 （Intravenous administration）Experimental treatment 1 intervention
Group H: dose level 8 of SPGL008 （Intravenous administration）Experimental treatment 1 intervention
Group I: dose level 1 of SPGL008 （Subcutaneous administration）Experimental treatment 1 intervention
Group J: dose level 2 of SPGL008 （Subcutaneous administration）Experimental treatment 1 intervention
Group K: dose level 3 of SPGL008 （Subcutaneous administration）Experimental treatment 1 intervention
Group L: dose level 4 of SPGL008 （Subcutaneous administration）Experimental treatment 1 intervention
Group M: dose level 5 of SPGL008 （Subcutaneous administration）Experimental treatment 1 intervention
Group N: dose level 6 of SPGL008 （Subcutaneous administration）Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicity (DLT)

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.

Time frame
During the first cycle. Each cycle is 21 days
2

Maximum tolerated dose (MTD)

MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.

Time frame
During the first cycle. Each cycle is 21 days

Secondary outcomes

1

Objective Response Rate (ORR)

Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.

Time frame
Up to 2 years
2

Cmax

Time frame
Up to 2 years
3

Tmax

Time frame
Up to 2 years
4

T1/2

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenyang Sunshine Pharmaceutical Co., LTD.

Lead sponsor

Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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