Actively Recruiting
A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SPGL008 Monotherapy for Patients With Advanced Malignant Tumors
Led by Shenyang Sunshine Pharmaceutical Co., LTD. · Updated on 2026-02-09
96
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
Sponsors
S
Shenyang Sunshine Pharmaceutical Co., LTD.
Lead Sponsor
S
Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating SPGL008, a biological product, for its safety, tolerability, and early effectiveness in patients with advanced malignant tumors. This phase I study involves two groups to assess intravenous and subcutaneous administration methods. The study uses a dose-escalation design to carefully examine how different doses affect patients. There are two main groups in the study: one receives SPGL008 through intravenous infusions, and the other through subcutaneous injections. Both groups undergo dose escalation, starting from lower doses and increasing to higher ones to find the safest and most tolerable dose levels. The treatment cycles last 21 days, during which safety and tolerability are closely monitored. Participants will be observed for dose-limiting toxicities and the maximum tolerated dose during the first 21-day cycle. Researchers will also measure responses to treatment, drug concentration levels, and how the drug is processed in the body over up to two years. Throughout the study, patients will have regular assessments including laboratory tests and monitoring to track safety and treatment effects. The total participation time may extend up to two years depending on outcomes.
CONDITIONS
Brief Title
A Phase I Study of SPGL008 in Subjects With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and/or females aged 18 to 75 years
- Histologically or cytologically confirmed advanced or metastatic malignant tumors
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 3 months
- Signed informed consent form
You will not qualify if you...
- Known uncontrolled or symptomatic central nervous system metastatic disease
- Adverse events from prior anticancer therapy greater than grade 1, except alopecia and fatigue
- Inadequate organ or bone marrow function
- Pregnant or breastfeeding women
- Known allergies, hypersensitivity, or intolerance to SPGL008
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each cycle is 21 days; repeated cycles until dose limiting toxicity or discontinuation
Participants receive SPGL008 monotherapy administered either intravenously or subcutaneously in escalating doses to evaluate safety and preliminary efficacy.
Regular visits during each 21-day cycle for dosing and monitoring
Trial Site Locations
Total: 1 location
1
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
Research Team
Y
yongsheng Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
14
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