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Reverse Triple Negative Immune Resistant Breast Cancer

NCT05076682 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-03

No results posted yet for this study

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.

Conditions

  • Triple-negative Breast Cancer

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhimin Shao, Professor · Fudan U

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05076682 on ClinicalTrials.gov