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

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

NCT ID: NCT06081959

Condition: Metastatic Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Gemcitabine
Capecitabine
Vinorelbine

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: SKB264
Description: IV infusion on day 1 and Day 15 of each 28 day cycle
Arm group label: SKB264 for injection

Intervention type: Drug
Intervention name: Eribulin
Description: 1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
Arm group label: Treatment of Physician's Choice

Intervention type: Drug
Intervention name: Capecitabine
Description: 1000-1250 mg/m2, po, bid, from day 1 to Day 15 of each 21 day cycle
Arm group label: Treatment of Physician's Choice

Intervention type: Drug
Intervention name: Gemcitabine
Description: 1000 mg/m2, IV infusion on day 1 and Day 8 of each 21day cycle
Arm group label: Treatment of Physician's Choice

Intervention type: Drug
Intervention name: Vinorelbine
Description: 25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
Arm group label: Treatment of Physician's Choice

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cancer Hospital Chinese Academy of Medical Science

Address:
City: Beijing
Zip: 100021
Country: China

Status: Recruiting

Contact:
Last name: BingHe Xu, PhD

Start date: October 31, 2023

Completion date: December 31, 2027

Lead sponsor:
Agency: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
Agency class: Industry

Source: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06081959