Trial Title:
LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer
NCT ID:
NCT06387628
Condition:
TNBC - Triple-Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Paclitaxel
Conditions: Keywords:
Immunotherapy
PD-1
CCR8
Triple-Negative Breast Cancer
TNBC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LM-108
Description:
LM-108, 10mg/kg, d1, q6w
Arm group label:
LM-108, toripalimab and eribulin
Arm group label:
LM-108, toripalimab and nab-paclitaxel
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Toripalimab, 240 mg, d1, q3w
Arm group label:
LM-108, toripalimab and eribulin
Arm group label:
LM-108, toripalimab and nab-paclitaxel
Intervention type:
Drug
Intervention name:
Eribulin
Description:
Eribulin 1.4 mg/m2, d1, 8 , q3w
Arm group label:
LM-108, toripalimab and eribulin
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
Nab paclitaxel 125 mg/m2, d1, 8 , q3w
Arm group label:
LM-108, toripalimab and nab-paclitaxel
Summary:
To evaluate the efficacy and safety of LM108 plus toripalimab plusnab-paclitaxel or
eribulin as first-line or post-line treatment in patients with metastatic triple-negative
breast cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years old (including boundary value), no gender limit;
2. ECOG score 0-1;
3. Expected survival ≥3 months;
4. Unresectable or metastatic or postoperative recurrent, histologically confirmed
advanced triple-negative breast cancer. Triple-negative breast cancer is defined as:
ER, PR and HER2 are negative. ER-negative and PR-negative are defined as tumors
without positive staining, the proportion of cells in all tumor cells is <1%;
HER2-negative is defined as: HER2 (0), HER2 (1+) or HER2 (2+) detected by
immunohistochemistry but negative by fluorescence in situ hybridization (FISH);
Cohort 2 requires histological confirmation of PD-L1 CPS ≥ 1;
5. Cohort 1 : at least one prior line at recurrence or metastasis setting with disease
progression or intolerable toxicity. In this situation, patients are allowed to be
enrolled: the time between the last intravenous dose of adjuvant chemotherapy and
first recurrence or metastasis is ≤6 months. Cohort 2: no prior line at recurrence
or metastasis setting is allowed, the time between the last intravenous dose of
adjuvant chemotherapy and first recurrence or metastasis ≥12 months.;
6. Provide sufficient fresh tissue specimens for biomarker analysis before treatment;
7. According to RECISTv1.1 standard, there is at least 1 measurable lesion;
8. Appropriate bone marrow and organ function before first dose :
- Bone Marrow: Platelets ( PLT ) ≥ 90 × 109 /L , absolute neutrophil count ( ANC
) ≥ 1.5 × 109 /L , hemoglobin ≥ 9 g/dL ;
- Coagulation: INR ≤ 1.5 , APTT ≤ 1.5 × ULN ;
- Liver function: Liver function is basically normal, total bilirubin ≤ 1.5 × ULN
( total bilirubin in patients with Gilbert syndrome ≤ 3 × ULN can be enrolled),
AST and ALT ≤ 2.5 × ULN (if there is liver metastasis, AST , ALT ≤ 5 × ULN );
- Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50
mL/min (according to Cockcroft-Gault formula);
- Cardiac function: left ventricular ejection fraction ( LVEF ) ≥ 50% ; female QT
interval ( QTcF ) ≤ 470 ms , male ≤ 450 ms .
9. Be able to well communicate with the investigator and understand and comply with the
requirements of this study.
Exclusion Criteria:
1. Cohort 1 : Previous use of eribulin and CCR8- targeting drugs; Cohort 2: previous
use of CCR8-targeting drugs and nab-paclitaxel, unless the interval between the last
dose of nab-paclitaxel in the adjuvant chemotherapy and first recurrence or
metastasis is ≥12 months;
2. Have received radiotherapy, chemotherapy, traditional Chinese medicine with
anti-tumor indications, and local therapy (interventional therapy but not including
tumor biopsy, ablation therapy, etc.) within 2 weeks before trial drug treatment;
3. Adverse events from previous anti-tumor treatments have not recovered to ≤ grade 1
according to CTCAE v5.0 (except for ≤ grade 2 toxicities judged by the investigator
to have no safety risk, such as alopecia, long-term toxicity caused by radiotherapy,
etc.);
4. Patients with known brain metastases. Those with stable brain metastases can be
enrolled;
5. Third space effusion that is clinically uncontrollable and unsuitable for
enrollment;
6. Participants with≥ grade 3 allergies to antibody drugs previously;
7. Taking systemic corticosteroids (>10 mg daily prednisone or equivalent dose) or
other systemic immunosuppressive drugs (including but not limited to prednisone,
dexamethasone, cyclophosphamide, azathioprine, methotrexate , thalidomide, and
anti-tumor necrosis factor drugs), topical, ocular, intra-articular, intranasal, and
inhaled corticosteroids are allowed;
8. Subjects with a known history of autoimmune diseases, including but not limited to
myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus,
rheumatoid arthritis, Guillain-Barre syndrome, multiplex syndrome sclerosis or
glomerulonephritis, except autoimmune-related hypothyroidism treated with stable
dose of hormone;
9. Known idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonia, idiopathic pneumonia, interstitial lung
disease, severe radiation pneumonitis, or subjects with evidence of active pneumonia
by chest CT scan screening.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Biyun Wang
Phone:
18017312387
Email:
pro_wangbiyun@163.com
Start date:
July 10, 2024
Completion date:
April 1, 2027
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/NCT06387628
