MedTrace Logo

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

NCT07509515 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

  • Triple-negative Breast Cancer (TNBC)

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2027-09-30
Completion
2028-03-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07509515 on ClinicalTrials.gov