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

NCT07022002 | Recruiting Phase 2

• 1 other identifier: SSGJ-705-201
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced, Recurrent or Metastatic Malignancies

Keywords

advanced malignancies

Outcome Measures

Primary Outcomes (3)

• Objective response rate (ORR)

  The primary efficacy end point

  12 months

• Incidence of Treatment-Emergent Adverse Events

  The primary safety end point

  12 months

• Severity of Treatment-Emergent Adverse Events

  The primary safety end point

  12 months

Secondary Outcomes (1)

• Progression-Free-Survival (PFS)

  24 months

Study Arms (2)

Part 1

EXPERIMENTAL

advanced gastric cancer and breast cancer that have failed standard treatment

Drug: SSGJ-705

Part 2

EXPERIMENTAL

previously untreated advanced gastric cancer and lung cancer

Drug: PD-1/L1 inhibitor combined with chemotherapy; Drug: SSGJ-705 combined with chemotherapy

Interventions

SSGJ-705 DRUG

anti-PD-1 (programmed cell death protein 1) and anti-HER2 (Human Epidermal GrowthFactor Receptor 2)bispecifc antibody

Part 1

PD-1/L1 inhibitor combined with chemotherapy DRUG

Immune checkpoint inhibitors

Part 2

SSGJ-705 combined with chemotherapy DRUG

anti-PD-1 and anti-HER2 bispecifc antibody

Part 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Jieer Ying, M.D

CONTACT

86-13858195803; hzyingjieer@163.com

Meifang Zheng, M.D.

CONTACT

86-15258894828; 794998553@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 15, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 12, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)