A Phase I Study of SSGJ-612 in Patients With Advanced Solid Tumors
NCT ID: NCT07032298
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2025-07-18
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SSGJ-612
In dose escalation phase, participants will receive one of the five increasing dose levels of SSGJ-612 respectively, intravenously (IV). During or after dose escalation, any dose levels that does not exceed the MTD can be expanded.
SSGJ-612
Intravenous injection
Interventions
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SSGJ-612
Intravenous injection
Eligibility Criteria
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Inclusion Criteria
2. Aged ≥18 and ≤75 years old at the time of signing the ICF, regardless of gender;
3. Expected survival ≥3 months;
4. Performance status (PS) score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale;
5. Patients with pathologically or cytologically confirmed locally advanced or metastatic malignant tumors who have failed standard treatment, are intolerant to standard treatment, or have no standard treatment available, and cannot undergo complete surgical resection or receive radical concurrent/sequential chemoradiotherapy;
6. Tumor tissue with HER2 expression;
7. At least one measurable tumor lesion assessed as the target lesion according to RECIST v1.1 criteria, and the lesion is suitable for repeated and accurate measurement.
Exclusion Criteria
2. Presence of active central nervous system (CNS) metastatic lesions;
3. Individuals with clinical symptoms or requiring repeated drainage (once a month or more frequently) of pleural effusion, pericardial effusion, or ascites;
4. Primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) test;
5. Known active tuberculosis; known active syphilis infection;
6. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
7. Use of any live vaccine or attenuated live vaccine within 4 weeks before the first dose, or plan to receive any live vaccine or attenuated live vaccine during the study;
8. Known severe allergic history to any component of the investigational drug, or history of severe allergic reaction to antibodies;
9. Pregnant or lactating women.
18 Years
75 Years
ALL
No
Sponsors
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Shenyang Sunshine Pharmaceutical Co., LTD.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SSGJ-612-101
Identifier Type: -
Identifier Source: org_study_id
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