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Recruiting NCT07022002

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

Phase II Interventional Locally Advanced, Recurrent or Metastatic Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SSGJ-705, PD-1/L1 inhibitor combined with chemotherapy, SSGJ-705 combined with chemotherapy.
Who it may be relevant to
Registry conditions: Locally Advanced, Recurrent or Metastatic Malignancies. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • 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

Primary outcome measures

  • Objective response rate (ORR) [Time frame: 12 months]
  • Incidence of Treatment-Emergent Adverse Events [Time frame: 12 months]
  • Severity of Treatment-Emergent Adverse Events [Time frame: 12 months]
Secondary outcome measures (1)
  • Progression-Free-Survival (PFS) [Time frame: 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhejiang Cancer Hospital — Hangzhou

Identifiers

NCT: NCT07022002 · SSGJ-705-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗