SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenyang Sunshine Pharmaceutical Co., LTD.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SSGJ-705
- PD-1/L1 inhibitor combined with chemotherapy
- SSGJ-705 combined with chemotherapy
Treatment groups
340 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov