NCT07005583

Clinical Study of QL1706 in Combination With Olaparib for the Treatment of Patients With Previously Treated Homologous Recombination Repair-Deficient Recurrent or Metastatic Triple-Negative Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, prospective, Phase II clinical trial designed to assess the efficacy and safety of QL1706 in combination with olaparib in patients with recurrent or metastatic triple-negative breast cancer (TNBC) harboring homologous recombination repair deficiency (HRD) who have received prior therapy.

Conditions

• Triple-Negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
DRUG	QL1706 Plus Olaparib	QL1706: 5 mg/kg administered via intravenous (IV) infusion every 3 weeks (Q3W). Olaparib: 300 mg (two 150 mg tablets) taken orally twice daily (BID). Treatment will continue until protocol-defined discontinuation criteria are met, including disease progression, unacceptable toxicity, withdrawal of consent, or death.

Timeline

• Start date: 2025-06-30
• Primary completion: 2027-05-30
• Completion: 2030-05-20
• First posted: 2025-06-05
• Last updated: 2025-06-05

Locations

1 site across 1 country: China