SSGJ-705 Monotherapy and Combination Therapy in Advanced HER2-Expressing Solid Tumors

Phase 2

Recruiting

• Conditions: Locally Advanced, Recurrent or Metastatic Malignancies
• Interventions: Drug: SSGJ-705; Drug: PD-1/L1 inhibitor combined with chemotherapy; Drug: SSGJ-705 combined with chemotherapy

• Registration Number: NCT07022002
• Lead Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

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 Timeline

• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-06-06
• Study First Posted: 2025-06-15
• Study Start: 2025-07-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-01
• Last Update Posted: 2025-08-03
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 340

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part 1	SSGJ-705	advanced gastric cancer and breast cancer that have failed standard treatment
Part 2	PD-1/L1 inhibitor combined with chemotherapy	previously untreated advanced gastric cancer and lung cancer
Part 2	SSGJ-705 combined with chemotherapy	previously untreated advanced gastric cancer and lung cancer

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Progression-Free-Survival (PFS)	24 months	The secondary efficacy end point

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China