Evaluating SKB264 for advanced breast cancer

A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy

This study is testing a new drug called SKB264 to see if it can help people with advanced breast cancer that hasn't responded to other treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06081959 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer. It is a randomized, open-label, multicenter Phase 3 study comparing SKB264 monotherapy to the Treatment of Physician's Choice (TPC) in patients who have previously failed at least one line of systemic chemotherapy. The study will enroll participants who meet specific eligibility criteria, including having measurable lesions and adequate organ function.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with HR+/HER2- breast cancer who have experienced treatment failure with prior chemotherapy.

Not a fit: Patients with only skin or bone lesions or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced breast cancer who have limited treatment choices.

How similar studies have performed: Other studies have shown promise with similar approaches in treating advanced breast cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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 this trial is running

Beijing, Beijing Municipality

• Cancer Hospital Chinese Academy of Medical Science — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yina Diao

Conditions Metastatic Breast Cancer