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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Triple-negative Breast Cancer (TNBC)
• Intervention / Treatment: Drug: QLC5513; Drug: QLC5513+QL1706

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).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhimin Shao, MD, PhD; Phone Number: 88807 +86-021-64175590; Email: zhimingshao@yahoo.com
• Study Contact Backup: Name: Yin Liu, MD; Phone Number: 88603 02164175590; Email: liuyinfudan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female aged ≥18 years;
2. 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);
3. Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;
4. Progression after at least one prior therapeutic regimens for advanced/metastatic TNBC.
5. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1.
6. Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions.
7. 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;
8. Eastern Cooperative Oncology Group (ECOG) score status 0-1 and life expectancy ≥3 months;
9. Fertile female subjects were required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last use of the study drug;
10. Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.

Exclusion Criteria:

1. 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);
2. Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);
3. 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;
4. 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;
5. Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment;
6. Pregnant or lactating patients;
7. Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years.
8. A prior history of treatment with antibody-drug conjugates (ADCs).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: QLC5513	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.
Experimental: Arm B : QLC5513+QL1706	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	refers to the period from the start of treatment to disease progression or death from any cause, whichever occurred first, or last PFS assessment for patients alive without progression.	Up to approximately 2 years
Duration of Response (DoR)	the time from the first documented evidence of complete response (CR) or partial response (PR) until the first date of documented disease progression or death from any cause, whichever occurs first.	Up to approximately 2 years
Disease Control Rate (DCR)	the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response, or stable disease to a therapeutic intervention in a clinical trial.	Up to approximately 2 years
Overall survival (OS)	Refers to the period from the moment of random assignment to the date of death for any reason.	Up to approximately 2 years
Number of Participants With Adverse Events (AEs)	Refers to the incidence and grade of adverse events (AE) and severe adverse events (SAE); AE is assessed according to the National Cancer Institute Common Toxicity Grading Criteria (NCI-CTCAE) version 5.0.	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms
• Other Study ID Numbers: SCHBCC-N044（QLC allcomer）

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No