Trials / Recruiting
RecruitingNCT07022002
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- Sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SSGJ-705 | anti-PD-1 (programmed cell death protein 1) and anti-HER2 (Human Epidermal GrowthFactor Receptor 2)bispecifc antibody |
| DRUG | PD-1/L1 inhibitor combined with chemotherapy | Immune checkpoint inhibitors |
| DRUG | SSGJ-705 combined with chemotherapy | anti-PD-1 and anti-HER2 bispecifc antibody |
Timeline
- Start date
- 2025-07-30
- Primary completion
- 2026-12-31
- Completion
- 2027-12-12
- First posted
- 2025-06-15
- Last updated
- 2025-08-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07022002. Inclusion in this directory is not an endorsement.