Not Yet RecruitingPhase 2

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

60 participantsStarted 2026-04-15

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Female aged ≥18 years;
✓. TNBC invasive breast cancer confirmed by histology (specific definition: ER \<1% positive tumor cells by immunohistochemistry are defined as ER negative, PR \<1% positive tumor cells are defined as PR negative, HER2 0-1+ or HER2 ++ but negative by FISH without amplification was defined as HER2 negative);
✓. Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;
✓. Progression after at least one prior therapeutic regimens for advanced/metastatic TNBC.
✓. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1.
✓. Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions.
✓. They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study, and have recovered from the acute toxicity of previous treatment (if surgery was performed, the wound has healed completely); No peripheral neuropathy or grade I peripheral neurotoxicity;
✓. Eastern Cooperative Oncology Group (ECOG) score status 0-1 and life expectancy ≥3 months;

Exclusion criteria

✕. Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis);
✕. Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);
✕. A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months;
✕. Persistent grade 1 or higher adverse reactions caused by previous treatments. The exception to this is hair loss or something the researchers don't think should be ruled out. Such cases should be clearly documented in the investigator's notes;
✕. Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment;
✕. Pregnant or lactating patients;
✕. Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years.
✕. A prior history of treatment with antibody-drug conjugates (ADCs).

What they're measuring

Objective Response Rate (ORR)

Timeframe: Up to approximately 2 years

Trial details

NCT IDNCT07509515

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

Zhimin Shao, MD, PhD

+86-021-64175590 zhimingshao@yahoo.com

View on ClinicalTrials.gov More Triple-negative Breast Cancer (TNBC) trials