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NCT Number: NCT07022002

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

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.

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Key information

Conditions

Locally Advanced, Recurrent or Metastatic Malignancies Disease Attributes Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SSGJ-705

Drug

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

PD-1/L1 inhibitor combined with chemotherapy

Drug

Immune checkpoint inhibitors

SSGJ-705 combined with chemotherapy

Drug

anti-PD-1 and anti-HER2 bispecifc antibody

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: 12 months

    The primary efficacy end point

  2. Incidence of Treatment-Emergent Adverse Events

    Time frame: 12 months

    The primary safety end point

  3. Severity of Treatment-Emergent Adverse Events

    Time frame: 12 months

    The primary safety end point

Secondary outcomes

  1. Progression-Free-Survival (PFS)

    Time frame: 24 months

    The secondary efficacy end point

Study contacts

Contact information is provided by the study sponsor or research team.

Jieer Ying, M.D

CONTACT

[email protected]

86-13858195803

Meifang Zheng, M.D.

CONTACT

[email protected]

86-15258894828

Sponsors and collaborators

Lead sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 15, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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