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

ConditionAdvanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWenjin Yin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female, age≥18 years old

Expected survival ≥12 weeks

ECOG 0-1

Pathologically confirmed recurrent or metastatic breast cancer not amenable to curative surgery

Disqualifiers

During pregnancy and lactation

Patients with central nervous system metastasis

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

123 Participants
are divided into 2 treatment groups
Group A: QL1706Experimental treatment 3 interventions
Group B: controlActive comparator 2 interventions

Trial outcomes

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.

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)

Secondary outcomes

1

Adverse events

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wenjin Yin

Lead sponsor

RenJi Hospital

Sponsor institution

Source ClinicalTrials.gov
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