Triple Negative Breast Cancer MetastaticPhase 2NCT07413601
Phase 2 Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Platinum Chemotherapy Versus Platinum Chemotherapy in the Treatment of Second-/Third-line Triple Negative Breast Cancer (TNBC)
A Phase 2 study testing QL1706 and Cisplatin/ Carboplatin in people with Triple Negative Breast Cancer Metastatic, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is an open-label, prospective, phase 2, randomized controlled study to evaluate the efficacy and safety of apolitovorrelizumab (QL1706) in combination with platinum chemotherapy versus platinum chemotherapy in the treatment of advanced unresectable and or metastatic triple negative breast cancer previously… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer Metastatic
- What is being tested?
- QL1706 and Cisplatin/ Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2026to 10 Feb 2029
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, regardless of gender;
- ECOG performance status: 0-1;
- Locally advanced or metastatic triple negative breast cancer confirmed by histopathology that is not suitable for curative treatment and cannot be treated surgically (Defined as negative for HER2, ER and PR expression according to the latest ASCO/CAP guidelines);
- Patients who have previously received first-line or second-line systemic treatment for locally advanced or metastatic breast cancer and have experienced recurrence within 12 months after the end of previous adjuvant therapy are counted as first-line systemic therapy;
- There is radiographic or objective evidence of disease progression at the last systemic treatment before or after the start of study treatment;
- Patients have at least one evaluable lesion (based on CT or MRI according to the RECIST 1.1 criteria);
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- Tissue or blood samples for biomarker testing can be provided, tissue samples during the baseline period (try to provide tumor puncture tissue after recent progression, if not, previously archived tissue is also available, 5-10 white slides); blood samples during the baseline period, after 2 cycles of treatment and after progression;
- Good organ function：The bone marrow function must be tested within 14 days before enrollment, white blood cell count (WBC) ≥3.5×109/L, hemoglobin (Hb) ≥90g/L, absolute neutrophil count (ANC) ≥1.5×109/L, and platelets (PLT) ≥80×109/L, and have not received blood transfusion or biological response modifiers (such as granulocytes, erythrocyte growth factor, Shengxuebao, etc.) within 14 days before the first dose. Liver function: Liver function must be tested within 14 years before enrollment. Patients without liver metastasis require serum total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. Requirements for patients with liver metastases: serum total bilirubin (TBIL) ≤1.5× the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN; alkaline phosphatase (ALP) ≤5×ULN in patients with liver metastases and no bone metastases, and ALP≤2.5×ULN in patients without liver and bone metastases. Renal function: Renal function should be tested within 14 days before enrollment, with blood creatinine ≤1.5×ULN or creatinine clearance ≥60mL/min (based on the Cockcroft-Gault formula). No serious cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%(confirmed by ECHO) .Coagulation function: International normalized ratio (INR) ≤1.5×ULN and activated partial thromboplastin time (APTT) ≤1.5×ULN (unless receiving the*utic anticoagulant drugs).
- Patients of childbearing potential must use effective contraceptive measures during the study until 6 months after the last dose.
- The patient voluntarily joined the study and signed the informed consent form, with good compliance.
Who cannot join
- Previous use of CTLA-4 monoclonal antibody or PD-1/PD-L1 and CTLA-4 bispecific antibodies (such as cardonilumab, KN046, etc.) or bifunctional combination antibodies (e.g., apolitto vorrelizumab);
- relapse within 6 months after the end of previous (new) adjuvant immune checkpoint inhibitor therapy; or progression-free survival of locally advanced or metastatic breast cancer receiving immune checkpoint inhibitor therapy; 6 months;
- relapse within 6 months after the end of previous (new) adjuvant platinum therapy; Or locally advanced or metastatic breast cancer receiving platinum therapy has a progression-free survival of <3 months (if the drug is discontinued due to non-tumor progression factors, but the duration of discontinuation is ≥3 months before randomization, you can participate in this study);
- Those who have experienced immune-related toxicity that led to permanent drug discontinuation during previous anti-tumor immunotherapy, or have experienced immune-related adverse events (irAEs) of ≥ grade 3 or immune-related myocarditis of ≥ grade 2 and are assessed by the investigator as not suitable for treatment in this study. Grade 3 endocrine abnormalities with stable control of hormone replacement therapy can be enrolled after the investigator assessed that these irAEs will not affect the administration of study drugs and safety assessment;
- Previous history of or concurrent interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary dysfunction, symptomatic bronchospasm, etc.;
- Previous history of other primary malignant tumors; Note: Except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical cancer in situ; Or patients who have received radical treatment and have not relapsed within 5 years of treatment can participate in this trial;
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- Have experienced severe allergic reactions to the pharmaceutical or inactive ingredients of the study drug;
- Adverse reactions from previous anti-tumor therapy have not recovered to NCI-CTCAE 5.0 grade evaluation ≤1 (Except for toxicities that are judged by the investigator to have no safety risks, such as hair loss);
- Have active autoimmune disease or have a history of autoimmune disease, are using immunosuppressants, or systemic hormone therapy (prednisone or other equivalent hormone at a dose>10mg/day), and continue to use it within 2 weeks prior to enrollment. Except for the following diseases: Clinically stable autoimmune thyroid disease; Type 1 diabetes treated with hormone replacement therapy; through local treatment (e.g., low-dose topical hormones) are well controlled and no autoimmune skin diseases requiring additional treatment due to acute exacerbation within 12 months prior to screening (such as eczema, psoriasis, chronic lichen simplex, or vitiligo with simple skin lesions accumulating less than 10% of the body surface area);
- Any serious or uncontrollable systemic disease, including hypertension that is not well controlled with drugs, according to the investigator's judgment (systolic blood pressure>160mmHg or diastolic blood pressure>100mmHg), uncontrolled diabetes, and signs of active bleeding, etc.;
- Uncontrolled cardiac disease, including heart failure of NYHA class 2 or above, unstable angina pectoris, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmia requiring treatment, prolonged QT syndrome, such as QTc>450ms (men) or QTc>470ms (women);
- Evidence of active infection includes but is not limited to hepatitis B (both HBsAg positive and HBVDNA≥2000IU/mL, and hepatitis caused by drugs or other reasons is excluded), hepatitis C (both anti-HCV antibody positive and HCV RNA positive) or human immunodeficiency virus (HIV) infection;
- Women with positive serum pregnancy tests or nursing do not agree to use adequate contraceptive measures during the study and for 6 months after receiving the trial drug;
- Subjects with known central nervous system metastases and/or cancerous meningitis (except for: asymptomatic, or treatment-treated and stable, no new brain metastases or radiographic evidence of expansion of brain metastases has been found for at least 4 weeks after treatment for brain metastases, and steroid or anticonvulsant treatment has been discontinued for at least 14 days before the start of study treatment);
- Other circumstances that the investigator deems unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
No. 17 Panjiayuan Nan Li, Chaoyang District, Beijing
Beijing, Beijing Municipality, 100021
About this study
Official title: Phase 2 Randomized Controlled Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Platinum Chemotherapy Versus Platinum Chemotherapy in the Treatment of Second-/Third-line Triple Negative Breast Cancer (TNBC)
This study is an open-label, prospective, phase 2, randomized controlled study to evaluate the efficacy and safety of apolitovorrelizumab (QL1706) in combination with platinum chemotherapy versus platinum chemotherapy in the treatment of advanced unresectable and or metastatic triple negative breast cancer previously treated with first-line or second-line systems. It is planned to enroll 78 subjects in this study. Subjects who meet the inclusion and exclusion criteria are divided into a random ratio of 1:1. The experimental group will receive QL1706 in combination with platinum chemotherapy selected by the investigator, and the control group will receive platinum chemotherapy selected by the investigator. A treatment cycle will be held every 3 weeks until disease progression or intolerable toxicity occurs. After subjects in the control group withdraw from the study, they are allowed to receive other treatments selected by the QL1706 co-investigators based on the subjects 'wishes. Efficacy assessments will be conducted every 6 weeks (42 days ±7 days) after treatment until disease progression, withdrawal of informed consent, death, or start of new antitumor therapy, whichever comes first.
- Conditions
- Triple Negative Breast Cancer Metastatic
- Being tested
- QL1706, Cisplatin/ Carboplatin
- 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.
QL1706Drug
IV infusion, 5mg/kg, given every 3 weeks, every 3 weeks as a cycle；
Cisplatin/ CarboplatinDrug
Cisplatin: 75mg/m2, intravenous infusion, Day 1 (or divided into 3 days), every 3 weeks as cycles; carboplatin: AUC5, intravenous infusion, Day 1, every 3 weeks as cycles;
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Drug: QL1706; Drug: Cisplatin/ Carboplatin |
| Control Group | Experimental | Not described Receives: Drug: Cisplatin/ Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Progression-Free Survival (PFS)
The time interval between the start of study drug use and the patient's disease progression or death.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcomes (5)
objective response rate（ORR）
Proportion of patients with complete response (CR) and partial response (PR) assessed according to RECIST 1.1 in solid tumors
Measured: assessed up to 36 months
disease control rate（DCR）
Proportion of patients with complete response, partial response, and stable response as assessed according to RECIST 1.1 in solid tumors.
Measured: assessed up to 36 months
duration of response
Time from the start of complete response (CR) or partial response (PR) on the first tumor assessment to progression of disease (PD) or death from any cause on the first tumor assessment
Measured: assessed up to 36 months
overall survival（OS）
Time from start of study drug to death from any cause
Measured: assessed up to 36 months
adverse events
Incidence of adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events (TRAEs), immune-related adverse events (irAEs)
Measured: assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start10 Feb 2026 (estimated)
- Primary completion10 Feb 2029 (estimated)
- Study completion10 Feb 2029 (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 MetastaticStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 78 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ma Fei，MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413601
- Sponsor's protocol ID
- NCC5927
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 17 Feb 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized Controlled Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Platinum Chemotherapy Versus Platinum Chemotherapy in the Treatment of Second-/Third-line Triple Negative Breast Cancer (TNBC)
- ClinicalTrials.gov ID
- NCT07413601
- Acronym / sponsor ID
- NCC5927
- Conditions
- Triple Negative Breast Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 10 Feb 2029 (estimated)
- Study completion
- 10 Feb 2029 (estimated)
- First posted
- 17 Feb 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.
This study is an open-label, prospective, phase 2, randomized controlled study to evaluate the efficacy and safety of apolitovorrelizumab (QL1706) in combination with platinum chemotherapy versus platinum chemotherapy in the treatment of advanced unresectable and or metastatic triple negative breast cancer previously treated with first-line or second-line systems. It is planned to enroll 78 subjects in this study. Subjects who meet the inclusion and exclusion criteria are divided into a random ratio of 1:1. The experimental group will receive QL1706 in combination with platinum chemotherapy selected by the investigator, and the control group will receive platinum chemotherapy selected by the investigator. A treatment cycle will be held every 3 weeks until disease progression or intolerable toxicity occurs. After subjects in the control group withdraw from the study, they are allowed to receive other treatments selected by the QL1706 co-investigators based on the subjects 'wishes. Efficacy assessments will be conducted every 6 weeks (42 days ±7 days) after treatment until disease progression, withdrawal of informed consent, death, or start of new antitumor therapy, whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: QL1706, Drug: Cisplatin/ Carboplatin |
| Control Group | Experimental | Drug: Cisplatin/ Carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years, regardless of gender;
- ECOG performance status: 0-1;
- Locally advanced or metastatic triple negative breast cancer confirmed by histopathology that is not suitable for curative treatment and cannot be treated surgically (Defined as negative for HER2, ER and PR expression according to the latest ASCO/CAP guidelines);
- Patients who have previously received first-line or second-line systemic treatment for locally advanced or metastatic breast cancer and have experienced recurrence within 12 months after the end of previous adjuvant therapy are counted as first-line systemic therapy;
- There is radiographic or objective evidence of disease progression at the last systemic treatment before or after the start of study treatment;
Key exclusion criteria (15 listed)
- Previous use of CTLA-4 monoclonal antibody or PD-1/PD-L1 and CTLA-4 bispecific antibodies (such as cardonilumab, KN046, etc.) or bifunctional combination antibodies (e.g., apolitto vorrelizumab);
- relapse within 6 months after the end of previous (new) adjuvant immune checkpoint inhibitor therapy; or progression-free survival of locally advanced or metastatic breast cancer receiving immune checkpoint inhibitor therapy; 6 months;
- relapse within 6 months after the end of previous (new) adjuvant platinum therapy; Or locally advanced or metastatic breast cancer receiving platinum therapy has a progression-free survival of <3 months (if the drug is discontinued due to non-tumor progression factors, but the duration of discontinuation is ≥3 months before randomization, you can participate in this study);
- Those who have experienced immune-related toxicity that led to permanent drug discontinuation during previous anti-tumor immunotherapy, or have experienced immune-related adverse events (irAEs) of ≥ grade 3 or immune-related myocarditis of ≥ grade 2 and are assessed by the investigator as not suitable for treatment in this study. Grade 3 endocrine abnormalities with stable control of hormone replacement therapy can be enrolled after the investigator assessed that these irAEs will not affect the administration of study drugs and safety assessment;
- Previous history of or concurrent interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary dysfunction, symptomatic bronchospasm, etc.;
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 |
|---|---|---|
| QL1706IV infusion, 5mg/kg, given every 3 weeks, every 3 weeks as a cycle； | Drug | Experimental |
| Cisplatin/ CarboplatinCisplatin: 75mg/m2, intravenous infusion, Day 1 (or divided into 3 days), every 3 weeks as cycles; carboplatin: AUC5, intravenous infusion, Day 1, every 3 weeks as cycles; | Drug | Control Group, Experimental |
Primary outcome
Median Progression-Free Survival (PFS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
The time interval between the start of study drug use and the patient's disease progression or death.
5 secondary outcomes
objective response rate（ORR）
Time frame: assessed up to 36 months
disease control rate（DCR）
Time frame: assessed up to 36 months
duration of response
Time frame: assessed up to 36 months
overall survival（OS）
Time frame: assessed up to 36 months
adverse events
Time frame: assessed up to 36 months
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 17 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QL1706 and Cisplatin/ Carboplatin in people with Triple Negative Breast Cancer Metastatic, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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 15 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 MFei (+86 13710217780, mafei2011@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Progression-Free Survival (PFS) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months). 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 17 Feb 2026.