A Phase I Study of SPGL008 in Subjects With Advanced Malignant Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SPGL008.
- Who it may be relevant to
- Registry conditions: Advanced Malignant Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SPGL008 Monotherapy for Patients With Advanced Malignant Tumors
Overview
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
- Drug SPGL008
Biological product
Primary outcome measures
- Dose Limiting Toxicity (DLT) [Time frame: During the first cycle. Each cycle is 21 days]
- Maximum tolerated dose (MTD) [Time frame: During the first cycle. Each cycle is 21 days]
Secondary outcome measures (5)
- Objective Response Rate (ORR) [Time frame: Up to 2 years]
- Cmax [Time frame: Up to 2 years]
- Tmax [Time frame: Up to 2 years]
- T1/2 [Time frame: Up to 2 years]
- AUC [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- 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;
- Signed informed consent form.
Exclusion criteria
- 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;
- Known allergies, hypersensitivity, or intolerance to SPGL008.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chongqing University Cancer Hospital — Chongqing
Identifiers
NCT: NCT07038005 · SPGL008-101