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TNBC, Triple Negative Breast CancerPhase 2NCT06786026

QL1706 Plus Chemotherapy +/- Bevacizumab in 1L Treatment of R/mTNBC

A Phase 2 study testing bevacizumab, QL1706 and Nab paclitaxel in people with TNBC, Triple Negative Breast Cancer, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study is to evaluate the efficacy and safety of QL1706 plus albumin-bound paclitaxel ± bevacizumab in 1L treatment of r/mTNBC Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
TNBC, Triple Negative Breast Cancer
What is being tested?
bevacizumab, QL1706 and Nab paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
9 Oct 2024to 31 Dec 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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily join this study and sign the informed consent form;
  • Female patients aged ≥18 years and ≤70 years old who had been dignosed with breast cancer;
  • According to the definition of the latest ASCO/CAP guidelines, histologically confirmed estrogen receptor negative (ER-) and progesterone receptor negative (PR-), human epidermal growth factor receptor 2 negative
  • For patients with locally advanced, recurrent or metastatic breast cancer who have not used any systematic treatment (it is allowed to accept adjuvant/neoadjuvant treatment, and the time from the last administration to recurrence and metastasis should be ≥ 6 months);
  • According to RECIST 1.1, there is at least one measurable lesion;
  • ECOG score: 0~1;
  • Tumor tissue specimens that can be used for biomarker detection;
  • Adequate organ function (no blood components or cell growth factor drugs are allowed within 14 days before the first medication): (1) Absolute neutrophil count ≥1.5×109/L; (2) Platelets ≥100×109/L; (3) Hemoglobin ≥90 g/L; (4) Serum albumin ≥30 g/L; (5) Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, the FT3 and FT4 levels should be examined at the same time. If the FT3 and FT4 levels are normal, you can be included in the group); (6) Serum total bilirubin ≤1.5×ULN,if liver metastasis is present, ≤3ULN; (7) ALT and AST ≤2.5×ULN, if liver metastasis is present, ALT and AST ≤5ULN; (8) AKP≤2.5×ULN; Serum creatinine ≤1.5×ULN; (9) International normalized ratio (INR) ≤1.5 (not receiving anticoagulant therapy).

Who cannot join

  • 1.The presence of any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism;Those who suffer from vitiligo or whose asthma has been completely relieved in childhood and do not need any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included); 2.Are currently using immunosuppressants or systemic steroid therapy to achieve immunosuppression ((in dosing exceeding 10 mg daily of prednisone equivalent), and are still using it within 2 weeks before enrollment; 3.Severe allergic reactions to other monoclonal antibodies; 4. Known history or evidence of interstitial lung disease or active non-infectious pneumonia; 5.Known central nervous system metastasis; 6.Known additional malignant tumors within the past 5 years (except cured basal cell carcinoma of the skin and cervical cancer in situ); 7. The presence of uncontrolled hypertension (systolic blood pressure \>140mmHg or diastolic blood pressure \>90mmHg) or dignosis with hypertensive crisis or hypertensive encephalopathy. Known history of hypertension are admitted to the study if their blood pressure is controlled below this standard and maintained with antihypertensive therapy.
  • 8.Patients with a history of severe cardiovascular and cerebrovascular disease, including but not limited to: (1) NYHA grade 2 or above heart failure (2) Unstable angina (3) Myocardial infarction within 1 year (4) Clinically significant supraventricular infarction or ventricular arrhythmia requiring treatment or intervention (5) QTc\>450ms (male); QTc\>470ms (female); 9.Those who are receiving thrombolysis or anticoagulation therapy; prophylactically use of low-dose aspirin and low-molecular-weight heparin are allowed; 10.Have clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment; if fecal occult blood is positive in the screening, it should be re-examined. If it is still positive after the reexamination, a gastroscopy is required; 11.The tumor invades vital blood vessels, or a high possibility that the cancer will invade important blood vessels in the future study period, which may lead to fatal bleeding; 12.Patients with pleural effusion, ascites or pericardial effusion that require drainage can be enrolled if the researcher assesses that the symptoms are stable after drainage; 13.Arterial/venous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 14.Major vascular disease (for example, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before the start of study treatment; 15.Urine routine shows urine protein ≥ ++ and confirmed 24-hour urine protein amount \>1.0 g; 16.Suffering from active infection, unexplained fever ≥38.5℃ within 7 days before taking the drug, or baseline white blood cell count \>15×109/L; 17.Those with congenital or acquired immune deficiency (such as HIV infection); those who are hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 IU/ml, or hepatitis C virus antibody positive; Have received live vaccines less than 4 weeks before study medication or may be vaccinated during the study period; 18.In the judgment of the researcher, the patient has other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, and serious laboratory tests. Abnormalities, accompanied by family or social factors, may affect the patient\'s safety.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wang Hongxia contact

021-64175590

whx365@126.com

Tao Zhonghua contact

13774315805

drtaozhh@126.com

China1 site, 1 recruiting
  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Wang hoangxia, 13524491606, whx365@126.com

    Recruiting

Other trials in China

About this study

Official title: QL1706 Plus Nab-paclitaxel +/- Bevacizumab As 1L Treatment in Recurrent or Metastatic Triple-Negative Breast Cancer: a Non-randomized, Multicenter Phase II Study

This study is to evaluate the efficacy and safety of QL1706 plus albumin-bound paclitaxel ± bevacizumab in 1L treatment of r/mTNBC

Being tested
bevacizumab, QL1706, Nab paclitaxel
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.

  • bevacizumabDrug

    bevacizumab

  • QL1706Drug

    Bispecific antibody (bsAB) targeting PD-1 and CLTA-4

  • Nab paclitaxelDrug

    albumin-bound paclitaxel

Study groups in NCT06786026
Study groupRoleWhat they receive
QL1706 +nab-POtherNot described
Receives: Drug: QL1706; Drug: Nab paclitaxel
QL1706 +nab-P+bevacizumab.OtherNot described
Receives: Drug: bevacizumab; Drug: QL1706; Drug: Nab paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR by investigator

    ORR (Objective response rate) is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1.

    Measured: At baseline, at the time point of every 6 weeks, up to 1 years

Secondary outcomes (4)
  1. DCR by investigator

    DCR (Disease control rate) is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD (stable disease) per RECIST v1.1.

    Measured: At baseline, at the time point of every 6 weeks, up to 1 year

  2. Safety (incidence rate of adverse event)

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Percentage of participants who experienced an adverse event and discontinued study drug due to an AE.

    Measured: From time of informed consent provided to 3 months after the last dose of study therapy

  3. PFS (Progression-Free Survival)

    PFS is the time from the date of the first dose until the date of documented radiographic disease progression or death (by any cause in the absence of progression).

    Measured: Up to 2 years

  4. OS (Overall Survival)

    OS is the time from the date of the first dose until the date of death by any cause.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2025
  2. Study start9 Oct 2024
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06786026
Sponsor's protocol ID
QLMA-BC-IIT-004
Status last verified
Jan 2025
First submitted
9 Oct 2024
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, QL1706 and Nab paclitaxel in people with TNBC, Triple Negative Breast Cancer, run by Fudan University 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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 6 Feb 2025. 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 Wang Hongxia (021-64175590, whx365@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR by investigator (time frame: At baseline, at the time point of every 6 weeks, up to 1 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 6 Feb 2025.

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