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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06387628 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior eribulin, CCR8-targeting drugs, nab-paclitaxel disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 negative is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify