Advanced Malignant Tumors
Conditions
Brief summary
This study includes two cohorts, respectively evaluating safety, tolerability and preliminary efficacy of intravenous and subcutaneous administration of SPGL008.
Detailed 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.
Interventions
DRUGSPGL008
Biological product
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T1/2 | Up to 2 years | — |
| Cmax | Up to 2 years | — |
| Objective Response Rate (ORR) | Up to 2 years | Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. |
| AUC | Up to 2 years | — |
| Tmax | Up to 2 years | — |
Countries
China
Contacts
CONTACTyongsheng Li
Outcome results
None listed