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RECRUITING
NCT05076682
PHASE2

Reverse Triple Negative Immune Resistant Breast Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

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

Interventions

DRUG

Choline

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

DRUG

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)

DRUG

Sodium Cromoglicate

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

DRUG

Efavirenz

Efavirenz 600mg qd, p.o

DRUG

SHR-A1811

4.8mg/kg q3w

DRUG

SHR-A2102

6mg/kg q3w

DRUG

SHR-1316

1200mg q3w

DRUG

Mecapegfilgrastim

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

DRUG

AK131

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

DRUG

Theophylline

Theophylline, 100mg bid, p.o.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China