NCT07509515

QLC5513 Alone or in Combination With QL1706 in Previously Treated Advanced or Metastatic TNBC.

An Open-label, Phase 2 Study of QLC5513 Alone or in Combination With Epalolimab Tovolimab (QL1706) in Previously Treated Advanced or Metastatic TNBC.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will evaluate the safety and efficacy of QLC5513 alone or in combination with QL1706 in patients with advanced or metastatic triple-negative breast cancer (TNBC) who had received ≥1 line of prior systematic therapy.

Detailed description

This is a Phase 2, randomized, open-label study. TNBC patients eligible for inclusion will be randomly assigned (1:2) to receive either QLC5513 alone (Arm 1) or QLC5513 plus QL1706 (Arm 2). After the completion or discontinuation of the study treatment, safety follow-up and survival follow-up will be performed. The primary objective is to evaluate the objective response rate (ORR).

Conditions

• Triple-negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
DRUG	QLC5513	Participants of Arm A will receive QLC5513 16 mg/kg intravenously on day 1 and day 8 every 3 weeks. QLC5513 is a Trop2-targeting ADC with a proprietary stable linker and an SN38 cytotoxic payload.
DRUG	QLC5513+QL1706	Participants of Arm B will receive QLC5513 16 mg/kg intravenously on day 1 and day 8 every 3 weeks and QL1706 5 mg/kg intravenously on day 1 every 3 weeks. QL1706 is a novel dual immune checkpoint blockade containing a mixture of anti-PD1 IgG4 and anti-CTLA4 IgG1 antibodies.

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-09-30
• Completion: 2028-03-30
• First posted: 2026-04-03
• Last updated: 2026-04-03