NCT05076682

Reverse Triple Negative Immune Resistant Breast Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase II, open-label, three-arm parallel study evaluating the efficacy and safety of combined treatment (sodium cromoglicate, choline, efavirenz, SHR 1811, SHR 2102, mecapegfilgrastim) with immune checkpoint inhibitor or immune checkpoint inhibitor rechallenge(AK131) in mTNBC (triple negative breast cancer) patients who progressed during or following previous immune checkpoint inhibitors. The investigators have achieved a breakthrough in the FUTURE study with an ORR (objective response rate) reaching 52.6% in IM (immunomodulatory) subtype TNBC patients. Despite this, there are still some IM subtype patients resistant to immunotherapy. How to reverse immunotherapy resistance or how to increase the sensitivity of immunotherapy efficacy, has become an urgent clinical problem to be solved. The preclinical results of our center show that sodium cromoglicate, choline, efavirenz, SHR 1811, SHR 2102, mecapegfilgrastim, AK131, theophylline play a potentially important role in regulating the tumor immune microenvironment and can inhibit the growth of tumors in mice, and enhance the efficacy of PD-1 inhibitors in mice. Based on preclinical studies, the investigators designed this study to enroll mTNBC patients who have progressed during or following immunotherapy, and to explore the efficacy of these drugs at a clinical level, providing new strategies of combined treatment for TNBC patients.

Conditions

• Triple-negative Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-30
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2021-10-13
• Last updated: 2025-12-03

Locations

1 site across 1 country: China