Cadonilimab, Triple-negative Breast Cancer
Conditions
Keywords
triple negative breast cancer, Cadonilimab, chemotherapy
Brief summary
The prognosis of recurrent and metastatic triple negative breast cancer (TNBC) is poor, and chemotherapy is still the main treatment for TNBC. Some studies have shown that combination therapy of antibodies targeting cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed cell death-1 (PD-1) significantly improves clinical benefit over PD-1 antibody alone. However, broad application of this combination has been limited by toxicities. Cadonilimab is a humanized immunoglobulin G1 bispecific antibody targeting PD-1 and CTLA-4. It mutates to eliminate Fc receptor and complement-mediated cytotoxic effects. The purpose of this study is to evaluate the efficacy and safety of Cadonilimab combined with chemotherapy as a first or second-line treatment of recurrent and metastatic TNBC. This study is a multicenter, single arm, phase II, non randomized, open label, Simon two-stage design. It is planned to enroll 27 late stage TNBC patients.
Interventions
DRUGCadonilimab
Patients were assigned to receive 10 mg/kg cadonilimab intravenously Q3W in combination with chemotherapy. The chemotherapy regimen is chosen by the physician.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Recurrent or metastatic TNBC patients; * TNBC defined by immunohistochemistry as ER\<1%, PR\<1%, Her2=0\ 1+, or 2+ while HER2 Fish test shows no amplification； * Previous received no or only first line chemotherapy treatment for recurrent or metastatic TNBC；When the time between cancer metastasis and the end of adjuvant chemotherapy exceeds 1 year, the systemic chemotherapy for metastasis treatment is recorded as first-line treatment; When less than 1year, the systemic chemotherapy for metastasis treatment is recorded as second-line treatment； * ages 18 to 75 years at the time of signing the informed consent form (ICF); * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; * expected survival of ≥3 months; at least one measurable lesion per RECIST (version1.1); * acceptable renal and liver function;
Exclusion criteria
* They had received ICIs (i.e., anti-PD-1 antibodies, anti-PD-L1 antibodies, and anti-CTLA-4 antibodies.)； * Patients with active central nervous system (CNS) metastatic lesions or meningeal metastases； * Patients with an active autoimmune disease that requires systemic treatment in the past two years； * A known history of primary immunodeficiency； * Pregnant or lactating women； * Previous or current abnormalities of any disease, treatment, laboratory tests may confuse the study results, affect the subject's participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | Up to 2 years | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AE | From the time of informed consent signed through 90 days after the last dose of drug | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | Up to 2 years | Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first. |
| Overall survival | Up to 2 years | Overall survival is defined as the time from the start of treatment with AK104 until death due to any cause. |
| Disease control rate | Up to 2 years | The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1. |
Countries
China
Contacts
Primary ContactJie Xiong, PhD
Outcome results
None listed