Phase 1 SSGJ-612 for advanced HER2‑positive solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label Phase I trial gives escalating doses of SSGJ-612 to adults with advanced HER2-expressing solid tumors to determine safety, pharmacokinetics, and preliminary anti-tumor activity. The dose-escalation stage uses an accelerated titration approach combined with a traditional 3+3 design to identify dose-limiting toxicities and determine the maximum tolerated dose or maximum administered dose. Once safe dose levels are identified, the dose-expansion stage enrolls larger cohorts at selected doses to further evaluate tolerability and early signs of efficacy. Eligible patients must have measurable disease per RECIST v1.1 and adequate performance status and organ function, and the trial is conducted at a single site in Luoyang, Henan.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily participate in this study, be willing to follow and complete all trial procedures, and sign the informed consent form;
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:

1. Presence of brainstem, meninges, or spinal cord metastasis, or spinal cord compression;
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.

Where it's running

• The First Affiliated Hospital of Henan University of Science & Technology
  Luoyang, Henan, China Recruiting

Study contacts

• Study coordinator: Jun Yao, M.D.
• Email: yaojun74@163.com
• Phone: 13663790098

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.