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NCT Number: NCT07180160

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

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.

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Key information

Conditions

Advanced Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location status: Recruiting

Location contact

Wenjin Yin

CONTACT

[email protected]

86(21)68385569

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QL1706

Drug

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

CDK4/6 inhibitor

Drug

palbociclib OR ribociclib OR abemaciclib OR dalpiciclib

Fulvestrant

Drug

SERD

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 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)

    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.

Secondary outcomes

  1. Adverse events

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

    Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenjin Yin, M.D.

CONTACT

[email protected]

86(21)68385569

Sponsors and collaborators

Lead sponsor

Wenjin Yin

Other

Registry information

Official study title

Iparomlimab and Tuvonralimab (QL1706) in Patients With Hormone Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial

Acronym: ITHRAN

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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