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

NCT ID: NCT06081959

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed Description

This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus Treatment of Physician's Choice (TPC) in subjects with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SKB264 for injection

Group Type: EXPERIMENTAL

SKB264

Intervention Type: DRUG

IV infusion on day 1 and Day 15 of each 28 day cycle

Treatment of Physician's Choice

Eribulin, capecitabine, gemcitabine or vinorelbine will be administered and managed according to the investigator's clinical judgment, guided by clinical practice.

Group Type: ACTIVE_COMPARATOR

Eribulin

Intervention Type: DRUG

1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

Capecitabine

Intervention Type: DRUG

1000-1250 mg/m2, po, bid, from day 1 to Day 15 of each 21 day cycle

Gemcitabine

Intervention Type: DRUG

1000 mg/m2, IV infusion on day 1 and Day 8 of each 21day cycle

Vinorelbine

Intervention Type: DRUG

25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

Interventions

SKB264

IV infusion on day 1 and Day 15 of each 28 day cycle

Intervention Type: DRUG

Eribulin

1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

Intervention Type: DRUG

Capecitabine

1000-1250 mg/m2, po, bid, from day 1 to Day 15 of each 21 day cycle

Intervention Type: DRUG

Gemcitabine

1000 mg/m2, IV infusion on day 1 and Day 8 of each 21day cycle

Intervention Type: DRUG

Vinorelbine

25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yina Diao

Role: CONTACT

diaoyina@kelun.com

86-13402828610

Facility Contacts

BingHe Xu, PhD

Role: primary

Other Identifiers

SKB264-Ⅲ-10

Identifier Type: -

Identifier Source: org_study_id