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Recruiting Phase 3

Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer

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About this study

The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.

Condition
Metastatic Breast Cancer
Tested
SKB264, Eribulin, Capecitabine, Gemcitabine, Vinorelbine
Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 13

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Metastatic Breast Cancer
  • Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF;
  • Histologically and/or cytologically confirmed HR+/HER2- breast cancer based on pathology reports on recent biopsy specimens or other pathological samples;
  • Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage;
  • Patients with at least one measurable lesion per RECIST 1.1 criteria; those with only skin or bone lesions cannot be included;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
  • Expected survival ≥ 12 weeks;
  • Adequate organ and bone marrow function;
  • Patients who are eligible for a chemotherapy regimen in the control group;
  • Female patients of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose;
  • Patients who voluntarily participate in the study and sign the ICF, and able to comply with the visit and related procedures stipulated in the plan.

Exclusion 16

  • Patients with a history of central nervous system (CNS) metastases or current CNS metastases；
  • Patients with other malignancies (except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix) within 3 years prior to the first dose;
  • Patients with any cardio cerebral Vascular disease or cardio cerebral vascular risk factors may affect investigational treatment;
  • Uncontrollable systemic diseases assessed by the investigator;
  • History of (noninfectious) interstitial lung disease (ILD)/noninfectious neumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or ILD/noninfectious pneumonitis at screening that cannot be excluded by imaging;
  • Clinically serious lung injuries caused by lung diseases;
  • Patients with active chronic Inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess or acute gastrointestinal bleeding;
  • Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1;
  • Active hepatitis B or hepatitis C;
  • Human immunodeficiency virus (HIV) antibody test positive or a history of acquired immunodeficiency syndrome (AIDS), known active syphilis infection;
  • Known allergy or hypersensitivity to SKB264, or the excipients of SKB264;
  • Prior TROP2 targeted therapy, prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy;
  • Patients who received major surgeries 4 weeks prior to the first dose of study treatment or planned to receive major surgeries during the study ;
  • Patients with concomitant infections requiring systemic antibiotic therapy within 2 week prior to the first dose of study treatment;
  • Patients who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study;
  • Pregnant or lactating women.

Where

1 site, 1 recruiting

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.