SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors
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
Shenyang Sunshine Pharmaceutical Co., LTD.
340 participants
Jul 30, 2025
INTERVENTIONAL
Conditions
Summary
This study was an open-label phase Ⅱ study to evaluate the safety and efficacy of SSGJ-705 Monotherapy and Combination Therapy in patients with advanced HER2-Expressing Solid Tumors.
Eligibility
Inclusion Criteria5
- 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 Criteria5
- 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.
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Interventions
anti-PD-1 (programmed cell death protein 1) and anti-HER2 (Human Epidermal GrowthFactor Receptor 2)bispecifc antibody
Immune checkpoint inhibitors
anti-PD-1 and anti-HER2 bispecifc antibody
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07022002