A Phase I Study of SSGJ-612 in Patients With Advanced Solid Tumors
ConditionAdvanced Malignant Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenyang Sunshine Pharmaceutical Co., LTD.
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- SSGJ-612
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov