Triple-negative Breast Cancer (TNBC)Phase 2NCT07509515
QLC5513 Alone or in Combination With QL1706 in Previously Treated Advanced or Metastatic TNBC.
A Phase 2 study testing QLC5513 and QLC5513+QL1706 in people with Triple-negative Breast Cancer (TNBC), run by Fudan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple-negative Breast Cancer (TNBC)
- What is being tested?
- QLC5513 and QLC5513+QL1706
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 30 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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;
- 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;
- Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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.
Read the 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)
- Being tested
- QLC5513, QLC5513+QL1706
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLC5513Drug
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.
QLC5513+QL1706Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: QLC5513 | Experimental | Not described Receives: Drug: QLC5513 |
| Arm B : QLC5513+QL1706 | Experimental | Not described Receives: Drug: QLC5513+QL1706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 2 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509515
- Sponsor's protocol ID
- SCHBCC-N044（QLC allcomer）
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07509515
- Acronym / sponsor ID
- SCHBCC-N044（QLC allcomer）
- Conditions
- Triple-negative Breast Cancer (TNBC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: QLC5513 | Experimental | Drug: QLC5513 |
| Arm B : QLC5513+QL1706 | Experimental | Drug: QLC5513+QL1706 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLC5513Participants 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 | Arm A: QLC5513 |
| QLC5513+QL1706Participants 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. | Drug | Arm B : QLC5513+QL1706 |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to approximately 2 years
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.
5 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to approximately 2 years
Duration of Response (DoR)
Time frame: Up to approximately 2 years
Disease Control Rate (DCR)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QLC5513 and QLC5513+QL1706 in people with Triple-negative Breast Cancer (TNBC), run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Shao, MD, PhD (+86-021-64175590 ext. 88807, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.