LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer

NCT ID: NCT06387628

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2027-04-01

Brief 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.

Conditions

TNBC - Triple-Negative Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LM-108, toripalimab and eribulin

Group Type: EXPERIMENTAL

LM-108

Intervention Type: DRUG

LM-108, 10mg/kg, d1, q6w

Toripalimab

Intervention Type: DRUG

Toripalimab, 240 mg, d1, q3w

Eribulin

Intervention Type: DRUG

Eribulin 1.4 mg/m2, d1, 8 , q3w

LM-108, toripalimab and nab-paclitaxel

Group Type: EXPERIMENTAL

LM-108

Intervention Type: DRUG

LM-108, 10mg/kg, d1, q6w

Toripalimab

Intervention Type: DRUG

Toripalimab, 240 mg, d1, q3w

Nab paclitaxel

Intervention Type: DRUG

Nab paclitaxel 125 mg/m2, d1, 8 , q3w

Interventions

LM-108

LM-108, 10mg/kg, d1, q6w

Intervention Type: DRUG

Toripalimab

Toripalimab, 240 mg, d1, q3w

Intervention Type: DRUG

Eribulin

Eribulin 1.4 mg/m2, d1, 8 , q3w

Intervention Type: DRUG

Nab paclitaxel

Nab paclitaxel 125 mg/m2, d1, 8 , q3w

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Biyun Wang, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Biyun Wang

Role: CONTACT

pro_wangbiyun@163.com

18017312387

Facility Contacts

Biyun Wang

Role: primary

pro_wangbiyun@163.com

18017312387

Other Identifiers

LM108-IIT-202

Identifier Type: -

Identifier Source: org_study_id