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

Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06081959
• Other study ID #: SKB264-?-10
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: November 30, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
• Contact: Yina Diao
• Phone: 86-13402828610
• Email: diaoyina[@]kelun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 376
• Est. completion date: December 31, 2027
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• SKB264
IV infusion on day 1 and Day 15 of each 28 day cycle
• Eribulin
1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
• Capecitabine
1000-1250 mg/m2, po, bid, from day 1 to Day 15 of each 21 day cycle
• Gemcitabine
1000 mg/m2, IV infusion on day 1 and Day 8 of each 21day cycle
• Vinorelbine
25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) assessed by BIRC per RECIST 1.1.	PFS, defined as the time from randomization to PD or death, whichever occurs first.	up to 24 months
Secondary	Overall Survival (OS)	OS, defined as the time from randomization to death	up to 24 months
Secondary	Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1	PFS, defined as the time from randomization to PD or death, whichever occurs first.	up to 24 months
Secondary	Objective Response Rate (ORR)	The percentage of patients with CR and PR assessed by BIRC and investigators per RECIST v 1.1	up to 24 months
Secondary	Disease Control Rate (DCR)	The percentage of patients who have achieved CR,PR and SD assessed by BIRC and investigators per RECIST v 1.1	up to 24 months
Secondary	Duration of Response (DoR)	From the date that response criteria are first met to the first occurrence of PD as determined by BIRC and investigators per RECIST v1.1 or death from any cause, whichever occurs first	up to 24 months
Secondary	Quality of life of patients evaluated using the EORTC QLQ-C30 scale	To assess the impact of SKB264 on disease related symptoms and health related quality of life (HRQoL) in this patient population	Up to 2 years
Secondary	AEs and SAEs	Incidence and severity of AEs and SAEs (per CTCAE 5.0), and clinically significant abnormal laboratory findings	AEs should be observed and recorded from signing the ICF until 30 days after the last dose. AEs occurring 30 days after the last dose are not required to be actively collected by the investigator.