Actively Recruiting
A Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SSGJ-709 in Patients With Advanced Malignant Tumors
Led by Shenyang Sunshine Pharmaceutical Co., LTD. · Updated on 2026-01-28
15
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
S
Shenyang Sunshine Pharmaceutical Co., LTD.
Lead Sponsor
M
Macquarie University, Australia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new drug called SSGJ-709 in patients with advanced malignant tumors. This open-label phase 1 study aims to assess the safety, how the drug moves through the body, and its anti-tumor activity. The trial focuses on patients with various advanced cancers, including some specific tumor types, who have limited treatment options. The study includes two phases: a dose escalation phase where the amount of SSGJ-709 is gradually increased to find the highest safe dose, and a dose expansion phase where the drug is given at a specific dose to more participants to further evaluate safety and effectiveness. Participants receive an infusion of SSGJ-709 once every 3 weeks. The dose escalation uses an accelerated titration and traditional 3+3 design with five dose levels. Participants will visit the clinic every 3 weeks for checkups and tests. Researchers will monitor safety by tracking dose-limiting toxicities and treatment-related adverse events over about one year. They will also measure how the drug is processed in the body and evaluate tumor response every 6 weeks. The total study duration includes ongoing safety and effectiveness assessments throughout the trial period.
CONDITIONS
Brief Title
A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Minimum life expectancy of 3 months
- Eastern Cooperative Oncology Group (ECOG) Performance status score of 0-1
- Locally advanced or metastatic malignant tumors confirmed by histopathology or cytology
- Preferred tumor types include head and neck squamous cell carcinoma, non-small cell lung cancer, esophageal squamous cell carcinoma or adenocarcinoma, gastric or gastroesophageal junction adenocarcinoma, colorectal adenocarcinoma, hepatocellular carcinoma, urothelial carcinoma, and clear cell renal cell carcinoma
- Patients who have failed or are intolerant to standard therapy, or lack standard of care, and cannot undergo curative surgery or chemoradiotherapy
- At least one measurable tumor lesion assessed per RECIST v1.1
- Adequate hematological and organ functions
You will not qualify if you...
- Brainstem, meningeal, spinal cord metastases or compression
- Active central nervous system metastases
- Clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- Other malignant tumors within 3 years prior to screening
- Autoimmune diseases requiring systemic treatment within 2 years before screening
- Positive for human immunodeficiency virus (HIV)
- Non-infectious pneumonia or interstitial lung disease requiring glucocorticoid therapy
- Serious or active infection requiring systemic treatment within 4 weeks prior to first dose
- Recent anti-tumor therapies within 3 weeks prior to first dose unless sufficient time has passed
- Recent small molecule targeted therapies, palliative local therapy, or immunomodulatory therapies within 2 weeks prior to first dose
- Herbal medicine with anti-tumor indication within 1 week prior to first dose
- Prior immunotherapy other than anti-PD-(L)1 therapy unless approved by sponsor
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 - Repeated 3-week cycles until disease progression or discontinuation
Participants receive SSGJ-709 infusion once every 3 weeks and visit the clinic for checkups and tests.
Visits every 3 weeks for infusion and assessments
Trial Site Locations
Total: 1 location
1
Southern Oncology Clinical Research Unit (SOCRU)
Adelaide, Australia
Actively Recruiting
Research Team
A
Andrew Parsonson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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