A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Triple Negative Breast Cancer Clinical Trial

Official title:

A Randomized, Open-Label, Multicenter Phase 3 Study of SKB264 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06279364
• Other study ID #: SKB264-?-11
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 2024
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.
• Contact: Xiaoping Jin, PhD
• Phone: 86-028-67255165
• Email: jinxp[@]kelun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting

Description:

This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 versus investigator's choice chemotherapy as first-line treatment for patients with unresectable recurrent or metastatic TNBC whose tumors do not express PD-L1 or in patients with PD-L1 positive tumors who received prior anti-PD-1/PD-L1 inhibitor in early setting.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 524
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

1. Histologically and/or cytologically confirmed TNBC.

2. De novo metastatic or relapsed = 6 months post completion of treatment with curative intent.

3. No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease.

4. Participants whose tumours are PD-L1-negative, or participants whose tumors are PD-L1 positive and have relapsed after prior anti-PD-1/PD-L1 inhibitor for early-stage disease.

5. At least one measurable lesion per RECIST v1.1.

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization.

7. A life expectancy of at least 3 months.

8. Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator.

9. Adequate organ and bone marrow function.

Key Exclusion Criteria:

1. Active second malignancy.

2. Uncontrolled or clinical significant cardiovascular disease.

3. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.

4. Active infection requiring systemic therapy within 2 weeks of randomization.

5. Active hepatitis B or hepatitis C virus infection.

6. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.

7. Known hypersensitivity to SKB264 or its excipients.

8. Previously received TROP2-targeted therapy or topoisomerase 1 inhibitors.

9. Prior treatment with the same investigator's choice chemotherapy (except taxane).

10. Pregnant or lactating women.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• SKB264
IV Infusion
• Paclitaxel
IV Infusion.
• Nab-paclitaxel
IV infusion.
• Capecitabine
Tablet. Oral route of administration.
• Eribulin
IV infusion.
• Carboplatin
IV infusion.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS is defined as the time from randomization until the date of death due to any cause.	Randomization up to approximately 40 months
Primary	Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)	PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.	Randomization up to approximately 28 months
Secondary	Objective Response Rate (ORR)	ORR is defined as the percentage of patients who achieve complete response(CR) or partial response (PR), as assessed by BICR/investigator per RECIST 1.1	Randomization up to approximately 28 months
Secondary	Duration of Response (DoR)	DoR is defined as the time from the date of first documented CR or PR until date of documented disease progression per RECIST 1.1, as assessed by BICR/investigator or death due to any cause, whichever occurs first.	Randomization up to approximately 28 months
Secondary	Progression-Free Survival (PFS) assessed by Investigator	PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator or death due to any cause, whichever occurs first.	Randomization up to approximately 28 months
Secondary	Disease control rate (DCR)	DCR is defined as the percentage of patients who achieve CR, PR or stable disease (SD), as assessed by BICR/investigator per RECIST 1.1	Randomization up to approximately 28 months
Secondary	Time to Response (TTR)	TTR is defined as the time from the date of randomization until the first documentation of CR or PR as assessed by BICR/investigator per RECIST 1.1.	Randomization up to approximately 28 months
Secondary	Adverse events(AEs) and severe adverse events (SAEs)	Incidence and severity of AEs and SAEs, and clinically significant lab abnormalities	AEs should be collected from signing the informed consent form (ICF) until 30 days after the last dose