OncoMatch/Clinical Trials/NCT06387628
LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer
Is NCT06387628 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including LM-108 and Toripalimab for tnbc - triple-negative breast cancer.
Treatment: LM-108 · Toripalimab · Eribulin · Nab paclitaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative (<1% positive staining)
ER-negative is defined as tumors without positive staining, the proportion of cells in all tumor cells is <1%
Required: PR (PGR) negative (<1% positive staining)
PR-negative is defined as tumors without positive staining, the proportion of cells in all tumor cells is <1%
Required: HER2 (ERBB2) negative (HER2 (0), HER2 (1+) or HER2 (2+) by IHC but negative by FISH)
HER2-negative is defined as: HER2 (0), HER2 (1+) or HER2 (2+) detected by immunohistochemistry but negative by fluorescence in situ hybridization (FISH)
Required: PD-L1 (CD274) CPS ≥ 1 (CPS ≥ 1)
Cohort 2 requires histological confirmation of PD-L1 CPS ≥ 1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: eribulin (eribulin)
Cohort 1 : Previous use of eribulin
Cannot have received: CCR8-targeting drugs
Cohort 1 : Previous use of ... CCR8- targeting drugs; Cohort 2: previous use of CCR8-targeting drugs
Cannot have received: nab-paclitaxel (nab-paclitaxel)
Exception: unless the interval between the last dose of nab-paclitaxel in the adjuvant chemotherapy and first recurrence or metastasis is ≥12 months
Cohort 2: previous use of ... nab-paclitaxel, unless the interval between the last dose of nab-paclitaxel in the adjuvant chemotherapy and first recurrence or metastasis is ≥12 months
Cannot have received: radiotherapy
Have received radiotherapy ... within 2 weeks before trial drug treatment
Cannot have received: chemotherapy
Have received ... chemotherapy ... within 2 weeks before trial drug treatment
Cannot have received: traditional Chinese medicine with anti-tumor indications
Have received ... traditional Chinese medicine with anti-tumor indications ... within 2 weeks before trial drug treatment
Cannot have received: local therapy (interventional therapy but not including tumor biopsy, ablation therapy, etc.)
Have received ... local therapy (interventional therapy but not including tumor biopsy, ablation therapy, etc.) within 2 weeks before trial drug treatment
Lab requirements
Blood counts
Platelets (PLT) ≥ 90 × 10^9/L, absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L, hemoglobin ≥ 9 g/dL
Kidney function
serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (according to Cockcroft-Gault formula)
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)
Cardiac function
left ventricular ejection fraction (LVEF) ≥ 50%; female QT interval (QTcF) ≤ 470 ms, male ≤ 450 ms
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 .
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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