SSGJ-705 alone and with chemotherapy for advanced HER2-positive cancers
Official title: A Phase II Study to Evaluate the Safety and Efficacy of SSGJ-705 Monotherapy and Combination Therapy in Patients With Advanced HER2-Expressing Solid Tumors
Run by Shenyang Sunshine Pharmaceutical Co., LTD. · NCT07022002 · Data updated 2026-11-12
This trial tests whether SSGJ-705, by itself or combined with chemotherapy (and in some arms with a PD‑1/L1 blocker), can help adults with advanced HER2-positive lung, breast, or stomach cancers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 340 (estimated) |
| Sponsor | Shenyang Sunshine Pharmaceutical Co., LTD. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | July 30, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 12, 2027 |
| Registry record updated | August 3, 2025 |
| Trial ID | NCT07022002 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with histologically confirmed locally advanced or metastatic HER2-expressing non-small cell lung cancer, breast cancer, or gastric/GEJ cancer, an ECOG performance status of 0–1, adequate organ function, and meeting the prior-treatment criteria for the relevant study part are the ideal candidates.
✕Probably not a fit
Patients who are pregnant or nursing, have symptomatic central nervous system metastases, unresolved high-grade toxicities from prior treatments, known allergies to antibody drugs or excipients, or inadequate organ or bone marrow function are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an open-label phase II trial that tests SSGJ-705 as monotherapy and in combination with chemotherapy (and in some arms with a PD‑1/L1 inhibitor) in patients with advanced HER2-expressing tumors. The study has two parts: Part 1 gives SSGJ-705 alone to previously treated advanced gastric and breast cancer patients, and Part 2 gives SSGJ-705 with chemotherapy to previously untreated advanced gastric and lung cancer patients. Key outcomes include safety, tolerability, and signals of anti-tumor activity. The trial is sponsored by Shenyang Sunshine Pharmaceutical and conducted at Zhejiang Cancer Hospital in Hangzhou, China.
Why it matters
Potential benefit: If successful, SSGJ-705 could offer a new treatment option that improves tumor control or extends survival for people with advanced HER2-positive cancers.
How similar studies have gone: Other HER2-targeted agents (for example trastuzumab and antibody–drug conjugates) have improved outcomes in HER2-positive cancers and combinations with chemotherapy or immunotherapy have shown promise, but SSGJ-705 itself is a novel agent without established clinical success yet.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and/or females over age 18. * Histologically and/or cytologically documented local advanced or metastatic non-Small Cell Lung Cancer（NSCLC），Breast Cancer（BC）or Gastric/Gastroesophageal Junction Cancer （G/GEJC). * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Expected survival \>3 months. * Signed informed consent form. Exclusion Criteria: * Any remaining adverse events (AEs) \> grade 1 from prior anti-tumor treatment as per Common Terminology Criteria for Adverse Events（CTCAE） v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity. * Pregnant or nursing women or women/men who are ready to give birth. * symptomatic central nervous system metastasis. * Allergy to other antibody drugs or any excipients in the study drugs. * Inadequate organ or bone marrow function.
Where it's running
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Jieer Ying, M.D
- Email: hzyingjieer@163.com
- Phone: 86-13858195803
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating SSGJ-705 for advanced malignant tumors
This study is testing a new treatment called SSGJ-705 to see if it is safe and effective for people with advanced cancer.
-
Testing GIGA-564 for advanced or metastatic solid tumors
This study is testing a new treatment called GIGA-564 to see if it is safe and how well it works for people with advanced solid tumors who can't use standard treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.