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
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 340
- Locations
- 1
- Primary Endpoint
- Objective response rate (ORR)
Study Overview
Brief 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.
Detailed Description
This study includes 2 Parts: Part 1 (705 monotherapy for advanced gastric cancer and breast cancer that have failed standard treatment), and Part 2 (705 in combination with chemotherapy for previously untreated advanced gastric cancer and lung cancer).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males and/or females over age
- •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-
- •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） v
- •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.
Arms & Interventions
Part 1
advanced gastric cancer and breast cancer that have failed standard treatment
Intervention: SSGJ-705 (Drug)
Part 2
previously untreated advanced gastric cancer and lung cancer
Intervention: PD-1/L1 inhibitor combined with chemotherapy (Drug)
Part 2
previously untreated advanced gastric cancer and lung cancer
Intervention: SSGJ-705 combined with chemotherapy (Drug)
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: 12 months
The primary efficacy end point
Incidence of Treatment-Emergent Adverse Events
Time Frame: 12 months
The primary safety end point
Severity of Treatment-Emergent Adverse Events
Time Frame: 12 months
The primary safety end point
Secondary Outcomes
- Progression-Free-Survival (PFS)(24 months)