RecruitingPhase 2NCT06387628

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

A Phase II Single Center Two Cohorts Trial of LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer


Sponsor

Fudan University

Enrollment

74 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests LM-108 (an experimental antibody-drug treatment) combined with a PD-1 immune checkpoint drug for people with advanced or metastatic triple-negative breast cancer (TNBC) — a type of breast cancer that does not respond to hormone therapies and is harder to treat. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed advanced or metastatic triple-negative breast cancer - Cohort 1: you have had at least one prior treatment for metastatic disease - Cohort 2: you have had no prior treatment for metastatic disease and your tumor is PD-L1 positive - You have at least one measurable tumor on scans - Your organs and blood counts are within acceptable ranges **You may NOT be eligible if...** - You have active brain metastases - You have a serious autoimmune disease or are on long-term steroids - You have had a major heart event in the past 6 months - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLM-108

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

DRUGToripalimab

Toripalimab, 240 mg, d1, q3w

DRUGEribulin

Eribulin 1.4 mg/m2, d1, 8 , q3w

DRUGNab paclitaxel

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


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06387628


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