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

Launched by SICHUAN KELUN-BIOTECH BIOPHARMACEUTICAL CO., LTD. · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SKB264 for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC). This type of breast cancer is challenging to treat because it doesn’t respond to some of the common therapies. The study aims to find out if SKB264 is more effective and safer than standard chemotherapy options for patients whose tumors do not express a specific protein called PD-L1, or for those who have already been treated with other therapies targeting PD-L1.

To participate in this trial, patients should be aged between 18 and 75, have a confirmed diagnosis of TNBC, and have either newly diagnosed metastatic cancer or have experienced a relapse at least six months after completing previous treatment. They should not have received any previous systemic treatment for their current advanced cancer. Participants will receive either SKB264 or standard chemotherapy and will be closely monitored for effectiveness and any potential side effects. This trial is currently open for enrollment, and it’s a chance for patients to potentially access a new treatment option while contributing to important medical research.

Gender

ALL

Eligibility criteria

• 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.