SSGJ-705 alone and with chemotherapy for advanced HER2-positive cancers

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

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: PHASE2
• Study type: Interventional
• Enrollment: 340 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07022002 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Hangzhou, Zhejiang

• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Jieer Ying, M.D

Conditions: Locally Advanced, Recurrent or Metastatic Malignancies, advanced malignancies