Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer (ITHRAN)

Wenjin Yin

Status and phase: Enrolling; Phase 2

Conditions: Advanced Breast Cancer

Treatments: Drug: Fulvestrant; Drug: QL1706; Drug: CDK4/6 inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT07180160

LY2025-215-C

Details and patient eligibility

About

This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer.

Enrollment: 123 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female, age≥18 years old
• Expected survival ≥12 weeks
• ECOG 0-1
• Pathologically confirmed recurrent or metastatic breast cancer not amenable to curative surgery
• ER and/or PR positive, HER2 negative
• At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1
• Previously treated with ≤2 lines chemotherapy for advanced disease; previously treated with ≤2 CDK4/6 inhibitors
• Adequate organ function

Exclusion criteria

• During pregnancy and lactation
• Patients with central nervous system metastasis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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123 participants in 2 patient groups

QL1706

Experimental group

Description:

QL1706 + CDK4/6 inhibitor + fulvestrant/letrozole

Treatment:

Drug: CDK4/6 inhibitor

Drug: QL1706

Drug: Fulvestrant

control

Active Comparator group

Description:

CDK4/6 inhibitor + fulvestrant/letrozole

Treatment:

Drug: CDK4/6 inhibitor

Drug: Fulvestrant