Actively Recruiting
A Phase 1 Study 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
133 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
This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and anti-tumor activity of SSGJ-709 as a single agent in patients with advanced malignancies.
CONDITIONS
Official 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 (PS) score of 0-1
- Diagnosis of locally advanced or metastatic malignant tumors confirmed by histopathology or cytology, including preferred tumor types such as 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 function
You will not qualify if you...
- Presence of brainstem, meningeal, or spinal cord metastases or compression
- Presence of active central nervous system (CNS) metastases
- Clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- History of 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)
- Prior or current non-infectious pneumonia or interstitial lung disease requiring glucocorticoids
- Serious infection within 4 weeks before first dose or any active infection needing systemic anti-infective therapy
- Receipt of anti-tumor therapies such as biological agents, chemotherapy, or investigational drugs within 3 weeks before first dose (except if more than 5 half-lives of the drug have passed)
- Receipt of small molecule targeted agents, palliative local therapy, or non-specific immunomodulatory therapy within 2 weeks before first dose
- Use of herbal medicine with anti-tumor indication within 1 week before first dose
- Prior immunotherapy other than anti-PD-(L)1 therapy without sponsor agreement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Southern Oncology Clinical Research Unit (SOCRU)
Adelaide, Australia
Actively Recruiting
Research Team
A
Andrew Parsonson
CONTACT
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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