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NOT YET RECRUITING
NCT07509515
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-04-15

Completion Date

2028-03-30

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

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.