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Reverse Triple Negative Immune Resistant Breast Cancer
Sponsor: Fudan University
Summary
This is a Phase II, open-label, seven-arm parallel study evaluating the efficacy and safety of combined treatment (sodium cromoglicate, choline, efavirenz, SHR 1811, SHR 2102, mecapegfilgrastim, theophylline) with immune checkpoint inhibitor or immune checkpoint inhibitor rechallenge(AK131) in mTNBC (triple negative breast cancer) patients who progressed during previous immune checkpoint inhibitors.
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2022-06-30
Completion Date
2027-03-31
Last Updated
2025-12-03
Healthy Volunteers
No
Conditions
Interventions
Choline
Choline 300mg tid or 500mg bid, p.o
anti-PD-1 antibody and chemotherapy
PD-1 antibody SHR1210 200mg q2w chemotherapy (whether and which should be given depends on the treatment regimen before enrollment)
Sodium Cromoglicate
Sodium Cromoglicate will be administered intranasally (nasal spray) (5 spray each nostril 4 times a day, 1 mg/spray)
Efavirenz
Efavirenz 600mg qd, p.o
SHR-A1811
4.8mg/kg q3w
SHR-A2102
6mg/kg q3w
SHR-1316
1200mg q3w
Mecapegfilgrastim
Mecapegfilgrastim, 6mg, d3, q3w, s.c.
AK131
AK131, 40mg/kg i.v., q2w
Theophylline
Theophylline, 100mg bid, p.o.
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, China