A Phase II Study of SSGJ-612 Plus a HER2-Targeted ADC in HR-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer

Sponsor
Shenyang Sunshine Pharmaceutical Co., LTD.
Study ID
NCT07757230
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SSGJ-612 (HER2-targeted antibody) — DRUG
    Intravenous injection
  • HER2-targeted ADC — DRUG
    Intravenous injection

Study Details

This study is a phase II clinical trial of SSGJ-612 combined with a human epidermal growth factor receptor 2 (HER2)-targeted antibody-drug conjugate (ADC) in patients with hormone receptor (HR)-positive, HER2-low or HER2-ultralow metastatic breast cancer.

Key Dates

First listed
Aug 11, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Feb 29, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
87 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
    Breast cancer patients who have received at least one line of chemotherapy for metastatic disease
  • Experimental: Part 2
    Breast cancer patients who have not received any chemotherapy for metastatic disease

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 2 years ]

Central Contacts

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