Reverse Triple Negative Immune Resistant Breast Cancer

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.

Trial Details

NCT ID
NCT05076682
Phase
PHASE2
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Choline
  • anti-PD-1 antibody and chemotherapy
  • Sodium Cromoglicate
  • Efavirenz
  • SHR-A1811
  • SHR-A2102
Locations (sample)
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • ECOG Performance Status of 0, 1, or 2
  • Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
  • Radiologic/objective evidence of recurrence or disease progression after immunotherapy(combined with targeted therapy or chemo ) for metastatic bre…
  • Adequate hematologic and end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment.

For full eligibility, visit ClinicalTrials.gov.

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