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RecruitingPhase 2NCT05076682

Reverse Triple Negative Immune Resistant Breast Cancer

Sponsor

Fudan University

Enrollment

80 participants

Start Date

Jun 30, 2022

Study Type

INTERVENTIONAL

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria7

  • 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 breast cancer(MBC)
  • Adequate hematologic and end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
  • have the cognitive ability to understand the protocol and be willing to participate and to be followed up.

Exclusion Criteria10

  • Symptomatic, untreated, or actively progressing CNS metastases
  • Active or history of autoimmune disease or immune deficiency
  • Significant cardiovascular disease
  • History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death
  • Treatment with chemotherapy, radiotherapy,immunotherapy or surgery (outpatient clinic surgery excluded) within 3 weeks prior to initiation of study treatment.
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study
  • History of allergies to the drug components of this trial
  • History of eosinophilosis or mastocytosis
  • Patients who have been using oral steroid hormones for a long time will need to stop for 4 weeks if they have used them occasionally in the past
  • For the Mecapegfilgrastim group, patients had previously received PEG-rhG-CSF in combination with immunotherapy.

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Interventions

DRUGCholine

Choline 300mg tid or 500mg bid, p.o

DRUGanti-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)

DRUGSodium Cromoglicate

Sodium Cromoglicate will be administered intranasally (nasal spray) (5 spray each nostril 4 times a day, 1 mg/spray)

DRUGEfavirenz

Efavirenz 600mg qd, p.o

DRUGSHR-A1811

4.8mg/kg q3w

DRUGSHR-A2102

6mg/kg q3w

DRUGSHR-1316

1200mg q3w

DRUGMecapegfilgrastim

Mecapegfilgrastim, 6mg, d3, q3w, s.c.

DRUGAK131

AK131, 40mg/kg i.v., q2w

DRUGTheophylline

Theophylline, 100mg bid, p.o.

Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT05076682