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
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
Treatments tested in this trial
- SPGL008
Treatment groups
96 Participants
are divided into 14 treatment groups14
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Shenyang Sunshine Pharmaceutical Co., LTD.
Lead sponsor
Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov