Trial Title:
QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer
NCT ID:
NCT06404736
Condition:
Early Breast Cancer
Neoadjuvant Therapy
TNBC, Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Paclitaxel
Carboplatin
Albumin-Bound Paclitaxel
Antibodies
Antibodies, Bispecific
Conditions: Keywords:
TNBC, Triple Negative Breast Cancer
Early breast cancer
Neoadjuvant Therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Bispecific antibody (bsAb) targeting PD-1 and CLTA-4
Description:
QL1706 is a novel bispecific combination antibody composed of a recombinant humanized
IgG4 monoclonal antibody targeting human PD-1 (programmed cell death protein 1) (PSB103)
and a recombinant humanized IgG1 monoclonal antibody targeting human CTLA-4 (cytotoxic
T-lymphocyte-associated protein 4) (PSB105). Both antibodies have undergone engineering
modifications to introduce mutations facilitating their correct assembly and preventing
mispairing, and are expressed in the same cell line at a predetermined ratio
(approximately 2:1).
Arm group label:
QL1706
Intervention type:
Drug
Intervention name:
Albumin-bound paclitaxel
Description:
Albumin-bound paclitaxel improves the solubility and delivery of paclitaxel to tumor
cells by binding to human albumin, facilitating its transportation through the
bloodstream and enhancing its uptake into tumor tissue. It works by binding to and
stabilizing microtubules within cancer cells, thereby disrupting the normal process of
cell division and leading to cell cycle arrest and apoptosis, ultimately resulting in the
death of cancer cells.
Arm group label:
QL1706
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin is a chemotherapy medication belonging to the platinum-based class of drugs,
commonly used in the treatment of various cancers, including ovarian cancer, lung cancer,
and bladder cancer. It functions by forming DNA adducts, disrupting DNA replication and
transcription processes in cancer cells, ultimately leading to cell death. Despite its
efficacy, carboplatin can cause side effects such as nausea, vomiting, and bone marrow
suppression.
Arm group label:
QL1706
Summary:
This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel
and carboplatin in a neoadjuvant setting, in high-risk, TNBC early breast cancer.
Detailed description:
This study is a single-arm, single-center, phase II clinical study designed to observe
and evaluate the efficacy and safety of QL1706 combined with Pcb regimen in the
neoadjuvant treatment of early-stage high-risk TNBC breast cancer.
It is planned to enroll 73 subjects. After the subjects are enrolled in the study, they
will receive 6 cycles of QL1706 combined with PCb regimen. A 3-week treatment cycle is
used until the treatment termination event specified in the protocol occurs. The subjects
will continue to undergo postoperative efficacy and safety visits after ending of the
treatment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily join this study and sign the informed consent form;
2. Female patients aged ≥18 years and ≤70 years old who are newly diagnosed with breast
cancer. According to the definition of the latest ASCO/CAP guidelines,
histopathologically confirmed TNBC breast cancer, histological grade II, TNM stage
T1cN1-cN2 or T2-T4, cN0-cN2;
3. According to RECIST 1.1, there is at least one measurable lesion;
4. ECOG score: 0~1;
5. Tumor tissue specimens that can be used for biomarker detection;
The function of vital organs meets the following requirements (no blood components or
cell growth factor drugs are allowed within 14 days before the first medication):
Inclusion Criteria:
1. Voluntarily join this study and sign the informed consent form; Female patients aged
≥18 years and ≤70 years old who are newly diagnosed with breast cancer. According to
the definition of the latest ASCO/CAP guidelines, histopathologically confirmed
ER+/HER2- breast cancer, histological grade II, Ki-67 ≥ 20% and TNM stage T1c-T2,
cN1-cN2 or T3- T4, cN0-cN2;
2. 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;
The function of vital organs meets the following requirements (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;
(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).
Exclusion Criteria:
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;
2. 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);
3. Are currently using immunosuppressants or systemic hormone therapy to achieve
immunosuppression (dose >10 mg/day prednisone or other effective hormones), and are
still using it within 2 weeks before enrollment;
4. Severe allergic reactions to other monoclonal antibodies; Known history or evidence
of interstitial lung disease or active non-infectious pneumonia;
5. Those with known central nervous system metastasis;
6. Suffered from other malignant tumors in the past 5 years or at the same time (except
cured basal cell carcinoma of the skin and cervical cancer in situ);
7. Suffering from high blood pressure that cannot be well controlled by
antihypertensive drug treatment (systolic blood pressure ≥140 mmHg or diastolic
blood pressure ≥90 mmHg); the above parameters are allowed to be achieved through
the use of antihypertensive treatment; there has been a hypertensive crisis or high
blood pressure in the past Hypertensive encephalopathy;
8. Have cardiac clinical symptoms or diseases that cannot be well controlled, such as
(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 are allowed to use
low-dose aspirin and low-molecular-weight heparin prophylactically;
10. Have clinically significant bleeding symptoms or a clear bleeding tendency within 3
months before enrollment; if fecal occult blood is positive during the baseline
period, it can be re-examined. If it is still positive after the reexamination, a
gastroscopy is required;
11. The tumor invades important blood vessels, or the researcher determines based on
imaging that there is 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. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia
patients, coagulation disorders, etc.);
15. Major vascular disease (for example, aortic aneurysm requiring surgical repair or
recent peripheral arterial thrombosis) within 6 months before the start of study
treatment;
16. Urine routine shows urine protein ≥ ++ and confirmed 24-hour urine protein amount
>1.0 g;
17. Suffering from active infection, unexplained fever ≥38.5℃ within 7 days before
taking the drug, or baseline white blood cell count >15×109/L;
18. 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;
19. 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhimin Shao
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Li Chen, MD
Phone:
+86-021-64175590
Start date:
May 7, 2024
Completion date:
November 7, 2030
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06404736
