Reverse Triple Negative Immune Resistant Breast Cancer

Phase 2 Recruiting 80 enrolled Fudan University

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Outcome

Met primary endpoint

paper The prespecified primary endpoint of this arm was met, with a confirmed objective response rate of 50.0%. PMID 40563015 ↗

Publications

Wu SY, Jin X, Liu Y, Wang ZY, Zuo WJ, Ma D, Xiao Y, Fu T, Xiao YL, Chen L, Liu XY, Fan L, Wang ZH, Shen M, Liu R, Chai WJ, Shao ZM, Jiang YZ. Mobilizing antigen-presenting mast cells in anti-PD-1-refractory triple-negative breast cancer: a phase 2 trial. Nat Med. 2025 Jul;31(7):2405-2415. doi: 10.1038/s41591-025-03776-7. Epub 2025 Jun 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AK131	Unknown	40 mg/kg	Intravenous
Subject	Adebrelimab	Monoclonal antibody	1200 mg	—
Subject	Choline	Other / unclassified	300 mg	Oral
Subject	Choline	Other / unclassified	500 mg	Oral
Subject	Cromolyn	Small molecule	1 mg	Other
Subject	Efavirenz	Other / unclassified	600 mg	Oral
Subject	Mecapegfilgrastim	Protein / enzyme biologic	6 mg	Subcutaneous
Subject	SHR-A1811	Monoclonal antibody	4.8 mg/kg	—
Subject	SHR-A2102	Other / unclassified	6 mg/kg	—
Subject	Theophylline	Small molecule	100 mg	Oral
Background	Camrelizumab	Monoclonal antibody	200 mg	—