RecruitingPhase 2NCT05076682

Reverse Triple Negative Immune Resistant Breast Cancer


Sponsor

Fudan University

Enrollment

80 participants

Start Date

Jun 30, 2022

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This trial is studying treatment options for triple-negative breast cancer (a type with no estrogen, progesterone, or HER2 receptors) that has stopped responding to immunotherapy, aiming to reverse immune resistance. **You may be eligible if...** - You have metastatic or locally advanced triple-negative breast cancer (TNBC) - Your cancer progressed during or after immunotherapy (combined with targeted therapy or chemotherapy) - You have at least one measurable tumor - Your general health is adequate (ECOG 0–2) - You are able to understand the study and commit to follow-up **You may NOT be eligible if...** - You have active brain metastases causing symptoms - You have an active autoimmune disease or immune deficiency - You have significant heart disease - You had another cancer within the past 5 years - You are pregnant or breastfeeding - You received cancer treatment within 3 weeks of joining Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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


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