Locally Advanced, Recurrent or Metastatic Malignancies
Conditions
Keywords
advanced malignancies
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).
Interventions
DRUGSSGJ-705
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
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 12 months | The primary efficacy end point |
| Incidence of Treatment-Emergent Adverse Events | 12 months | The primary safety end point |
| Severity of Treatment-Emergent Adverse Events | 12 months | The primary safety end point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free-Survival (PFS) | 24 months | The secondary efficacy end point |
Countries
China
Contacts
Primary ContactJieer Ying, M.D
Backup ContactMeifang Zheng, M.D.
Outcome results
None listed