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

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

This trial will test SSGJ-612, a new drug, in adults with advanced HER2‑expressing solid tumors who have exhausted standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. (Industry-sponsored)
• Locations: 1 site (Luoyang, Henan)
• Trial ID: NCT07032298 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with pathologically confirmed advanced or metastatic HER2‑expressing solid tumors, ECOG 0–1, measurable disease by RECIST v1.1, and who have exhausted or are intolerant of standard treatments are ideal candidates.

Not a fit: Patients without HER2 expression, with poor performance status, active central nervous system (brainstem/meningeal/spinal cord) metastases, or expected survival under 3 months are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, SSGJ-612 could provide a new targeted treatment option for patients with HER2‑expressing tumors who have limited standard therapies.

How similar studies have performed: Other HER2‑targeted therapies have shown meaningful benefits in HER2‑positive cancers, but SSGJ-612 itself is a novel agent undergoing its first human dose-finding evaluation.

Eligibility criteria

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 this trial is running

Luoyang, Henan

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

Study contacts

• Study coordinator: Jun Yao, M.D.

Conditions Advanced Malignant Tumors