Actively Recruiting
LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer
Led by Fudan University · Updated on 2024-08-02
74
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
LM-108 in Combination With PD-1 Based Treatment for Patients With Recurrent or Metastatic Triple - Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-75 years old, any gender
- ECOG performance status score of 0-1
- Expected survival of at least 3 months
- Histologically confirmed advanced triple-negative breast cancer that is unresectable, metastatic, or postoperative recurrent
- Triple-negative breast cancer defined by negative ER, PR, and HER2 status
- Cohort 2 requires PD-L1 CPS score of 1 or higher
- For Cohort 1, at least one prior treatment line at recurrence or metastasis with progression or intolerable toxicity; time from last adjuvant chemotherapy to recurrence/metastasis 6 months or less
- For Cohort 2, no prior treatment at recurrence or metastasis; time from last adjuvant chemotherapy to recurrence/metastasis 12 months or more
- Provide sufficient fresh tissue specimens for biomarker analysis before treatment
- At least one measurable lesion per RECIST v1.1
- Adequate bone marrow, coagulation, liver, renal, and cardiac function before first dose
- Ability to communicate with the investigator and comply with study requirements
You will not qualify if you...
- For Cohort 1, prior use of eribulin and CCR8-targeting drugs; for Cohort 2, prior use of CCR8-targeting drugs and nab-paclitaxel unless last nab-paclitaxel dose was at least 12 months ago
- Radiotherapy, chemotherapy, traditional Chinese medicine with anti-tumor effects, or local therapy within 2 weeks before study drug treatment
- Unresolved adverse events from prior anti-tumor treatments greater than grade 1 except some grade 2 toxicities without safety risk
- Known brain metastases (stable brain metastases allowed)
- Clinically uncontrollable third space effusions
- History of grade 3 or higher allergies to antibody drugs
- Taking systemic corticosteroids (>10 mg prednisone daily) or systemic immunosuppressive drugs (topical and local corticosteroids allowed)
- History of autoimmune diseases except stable autoimmune hypothyroidism
- Known serious lung diseases or active pneumonia by chest CT scan screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
B
Biyun Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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