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

NCT07180160 | Recruiting Phase 2 DMC

• 1 other identifier: LY2025-215-C
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first.

  From the date of starting study treatment to the date of first documentation of disease progression or death from any cause (up to approximately 1 year)

Secondary Outcomes (1)

• Adverse events

  From the date of starting study treatment to the end of the treatment (up to approximately 1 year)

Study Arms (2)

QL1706

EXPERIMENTAL

QL1706 + CDK4/6 inhibitor + fulvestrant/letrozole

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

control

ACTIVE COMPARATOR

CDK4/6 inhibitor + fulvestrant/letrozole

Drug: CDK4/6 inhibitor; Drug: Fulvestrant

Interventions

QL1706 DRUG

QL1706 is a single bifunctional MabPair product consisting of two engineered monoclonal antibodies (anti-PD-1 and anti-CTLA-4).

QL1706

CDK4/6 inhibitor DRUG

palbociclib OR ribociclib OR abemaciclib OR dalpiciclib

QL1706; control

Fulvestrant DRUG

SERD

QL1706; control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wenjin Yin: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Interventions

Fulvestrant

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Wenjin Yin, M.D.

  Renji Hospital,School of Medicine, Shanghai Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjin Yin, M.D.

CONTACT

86(21)68385569; yinwenjin@renji.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief of Breast Surgery Department

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 18, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)