RecruitingPhase 1NCT07032298

A Phase I Study of SSGJ-612 in Patients With Advanced Solid Tumors

Phase I Clinical Study on the Safety, Pharmacokinetics and Antitumor Activity of SSGJ-612 in Patients With Advanced Solid Tumors

Sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Enrollment

30 participants

Start Date

Jul 18, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Malignant Tumors

Summary

This study is an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSGJ-612 in patients with advanced malignant solid tumors expressing HER2.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

Voluntarily participate in this study, be willing to follow and complete all trial procedures, and sign the informed consent form;
Aged ≥18 and ≤75 years old at the time of signing the ICF, regardless of gender;
Expected survival ≥3 months;
Performance status (PS) score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale;
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;
Tumor tissue with HER2 expression;
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 Criteria9

Presence of brainstem, meninges, or spinal cord metastasis, or spinal cord compression;
Presence of active central nervous system (CNS) metastatic lesions;
Individuals with clinical symptoms or requiring repeated drainage (once a month or more frequently) of pleural effusion, pericardial effusion, or ascites;
Primary or secondary immunodeficiency, including positive human immunodeficiency virus (HIV) test;
Known active tuberculosis; known active syphilis infection;
Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
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;
Known severe allergic history to any component of the investigational drug, or history of severe allergic reaction to antibodies;
Pregnant or lactating women.