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

NCT06387628 | Recruiting Phase 2

• 1 other identifier: LM108-IIT-202
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Keywords

Immunotherapy; PD-1; CCR8; Triple-Negative Breast Cancer; TNBC

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  6 weeks

Secondary Outcomes (5)

• DoR

  6 weeks

• DCR

  6 weeks

• PFS

  6 weeks

• OS

  6 weeks

• Adverse events

  6 weeks

Study Arms (2)

LM-108, toripalimab and eribulin

EXPERIMENTAL

Drug: LM-108; Drug: Toripalimab; Drug: Eribulin

LM-108, toripalimab and nab-paclitaxel

EXPERIMENTAL

Drug: LM-108; Drug: Toripalimab; Drug: Nab paclitaxel

Interventions

LM-108 DRUG

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

LM-108, toripalimab and eribulin; LM-108, toripalimab and nab-paclitaxel

Toripalimab DRUG

Toripalimab, 240 mg, d1, q3w

LM-108, toripalimab and eribulin; LM-108, toripalimab and nab-paclitaxel

Eribulin DRUG

Eribulin 1.4 mg/m2, d1, 8 , q3w

LM-108, toripalimab and eribulin

Nab paclitaxel DRUG

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

LM-108, toripalimab and nab-paclitaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old (including boundary value), no gender limit;
• ECOG score 0-1;
• Expected survival ≥3 months;
• 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;
• 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.;
• Provide sufficient fresh tissue specimens for biomarker analysis before treatment;
• According to RECISTv1.1 standard, there is at least 1 measurable lesion;
• 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 .
• Be able to well communicate with the investigator and understand and comply with the requirements of this study.

You may not qualify if:

• 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;
• 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;
• 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.);
• Patients with known brain metastases. Those with stable brain metastases can be enrolled;
• Third space effusion that is clinically uncontrollable and unsuitable for enrollment;
• Participants with≥ grade 3 allergies to antibody drugs previously;
• 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;
• 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;
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

toripalimab; eribulin; Taxes

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Central Study Contacts

Biyun Wang

CONTACT

18017312387; pro_wangbiyun@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 29, 2024
• Study Start: July 10, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

CN (1)