Actively Recruiting
Phase I Study on Safety, Pharmacokinetics, and Antitumor Activity of SSGJ-612 in Adults With Advanced Solid Tumors
Led by Shenyang Sunshine Pharmaceutical Co., LTD. · Updated on 2025-07-25
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, how the body processes the drug, and the anti-tumor effects of SSGJ-612 in adults aged 18 to 75 with advanced malignant solid tumors that express HER2. This open-label Phase I study focuses on patients whose tumors have not responded to standard treatments or who cannot undergo surgery or certain therapies. The trial has two parts: a dose escalation phase and a dose expansion phase. During dose escalation, participants receive one of five increasing doses of SSGJ-612 via intravenous injection to find the maximum safe dose. If doses are well tolerated, those doses will be further tested in larger groups during the dose expansion phase. Participants will be closely monitored for side effects and how their tumors respond over about one year. Researchers will assess tumor size using RECIST criteria and measure drug levels in the blood. Safety checks include tracking adverse events and dose-limiting toxicities. The study includes regular evaluations to understand the drug's effects and tolerability throughout the treatment period.
CONDITIONS
Brief Title
A Phase I Study of SSGJ-612 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and complete all trial procedures with signed informed consent
- Aged 18 to 75 years old at the time of consent
- Expected survival of at least 3 months
- Performance status score of 0-1 on the ECOG scale
- Have pathologically or cytologically confirmed locally advanced or metastatic malignant tumors
- Have tumors expressing HER2
- Have at least one measurable tumor lesion suitable for repeated accurate measurement per RECIST v1.1
- Have failed standard treatment, are intolerant to standard treatment, or have no standard treatment available
- Cannot undergo complete surgical resection or radical concurrent/sequential chemoradiotherapy
You will not qualify if you...
- Presence of brainstem, meninges, or spinal cord metastasis or spinal cord compression
- Active central nervous system metastatic lesions
- Clinical symptoms or frequent drainage of pleural effusion, pericardial effusion, or ascites (once a month or more)
- Primary or secondary immunodeficiency, including positive HIV test
- Known active tuberculosis or active syphilis infection
- History of allogeneic organ or hematopoietic stem cell transplantation
- Use of any live or attenuated live vaccine within 4 weeks before first dose or planned use during study
- Severe allergy to any component of the investigational drug or history of severe allergic reaction to antibodies
- Pregnant or breastfeeding women
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 - Up to 1 year
Participants receive escalating doses of SSGJ-612 by intravenous injection to evaluate safety and determine the maximum tolerated dose. Dose levels that do not exceed the maximum tolerated dose may be further expanded and evaluated.
Multiple visits for dosing and safety assessments during treatment
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Actively Recruiting
Research Team
J
Jun Yao, M.D.
C
Cai'e Wang, M.D.
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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