Evaluating SKB264 for advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Yina Diao
• Email: diaoyina@kelun.com
• Phone: 86-13402828610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PRT13722 in advanced HR+/HER2- breast cancer

  This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.

  Recruiting Phase 1 Prelude Therapeutics Incorporated · Maumee, Ohio · NCT07905001

• Personalized treatment after endocrine therapy failure in metastatic breast cancer

  The study tests whether using a patient’s fresh tumor sample to try different drugs outside the body can help pick the next therapy for hormone receptor-positive, HER2-negative metastatic breast cancer that progressed on endocrine therapy.

  Recruiting Tel-Aviv Sourasky Medical Center · Tel Aviv · NCT07895160

• SSGJ-612 plus a HER2-targeted ADC in HR-positive, HER2-low metastatic breast cancer

  This phase II study tests whether adding SSGJ-612 to a HER2-targeted antibody-drug conjugate helps people with HR-positive, HER2-low or ultralow metastatic breast cancer.

  Recruiting Phase 2 Shenyang Sunshine Pharmaceutical Co., LTD. · Guangzhou, Guangdong · NCT07757230

• SMP-656 in HER2-positive advanced breast cancer after ADC therapy

  This trial tests whether SMP-656 given by IV every 3 weeks can help people with HER2-positive locally advanced or metastatic breast cancer who progressed after a HER2-targeted antibody-drug conjugate.

  Recruiting Phase 2 Chengdu SciMount Pharmatech Co., Ltd. · Hefei, Anhui and 14 other locations · NCT07726342

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• T-DXd–based therapy followed by targeted HER2 blockade and endocrine therapy in first-line HER2+ / HR+ metastatic breast cancer

  This trial tests a sequence of therapies starting with T-DXd plus pertuzumab, then a maintenance phase with dual HER2 blockade, endocrine therapy, and CDK4/6 inhibitor, with a retreatment option of T-DXd if disease progresses.

  Recruiting at 5 sites Phase 3 Daiichi Sankyo · Columbia, Maryland and 4 other locations · NCT07683754

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.