This study includes two cohorts, respectively evaluating safety, tolerability and preliminary efficacy of intravenous and subcutaneous administration of SPGL008.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Chongqing University Cancer Hospital
Chongqing
Chongqing Municipality
Recruiting
More Shenyang Sunshine Pharmaceutical Co., LTD. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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