QL1706 Plus Chemotherapy +/- Bevacizumab in 1L Treatment of R/mTNBC

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFudan University

About this trial

This study is to evaluate the efficacy and safety of QL1706 plus albumin-bound paclitaxel ± bevacizumab in 1L treatment of r/mTNBC

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily join this study and sign the informed consent form;

Female patients aged ≥18 years and ≤70 years old who had been dignosed with breast cancer;

According to the definition of the latest ASCO/CAP guidelines, histologically confirmed estrogen receptor negative (ER-) and progesterone receptor negative (PR-), human epidermal growth factor receptor 2 negative

For patients with locally advanced, recurrent or metastatic breast cancer who have not used any systematic treatment (it is allowed to accept adjuvant/neoadjuvant treatment, and the time from the last administration to recurrence and metastasis should be ≥ 6 months);

Disqualifiers

1.The presence of any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism;Those who suffer from vitiligo or whose asthma has been completely relieved in childhood and do not need any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included); 2.Are currently using immunosuppressants or systemic steroid therapy to achieve immunosuppression ((in dosing exceeding 10 mg daily of prednisone equivalent), and are still using it within 2 weeks before enrollment; 3.Severe allergic reactions to other monoclonal antibodies; 4. Known history or evidence of interstitial lung disease or active non-infectious pneumonia; 5.Known central nervous system metastasis; 6.Known additional malignant tumors within the past 5 years (except cured basal cell carcinoma of the skin and cervical cancer in situ); 7. The presence of uncontrolled hypertension (systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg) or dignosis with hypertensive crisis or hypertensive encephalopathy. Known history of hypertension are admitted to the study if their blood pressure is controlled below this standard and maintained with antihypertensive therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • bevacizumab

    Drug

    bevacizumab

  • QL1706

    Drug

    Bispecific antibody (bsAB) targeting PD-1 and CLTA-4

  • Nab paclitaxel

    Drug

    albumin-bound paclitaxel

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: QL1706 +nab-POther 2 interventions
Group B: QL1706 +nab-P+bevacizumab.Other 3 interventions

Trial outcomes

Primary outcomes

1

ORR by investigator

ORR (Objective response rate) is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1.

Time frame
At baseline, at the time point of every 6 weeks, up to 1 years

Secondary outcomes

1

DCR by investigator

DCR (Disease control rate) is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD (stable disease) per RECIST v1.1.

Time frame
At baseline, at the time point of every 6 weeks, up to 1 year
2

Safety (incidence rate of adverse event)

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Percentage of participants who experienced an adverse event and discontinued study drug due to an AE.

Time frame
From time of informed consent provided to 3 months after the last dose of study therapy
3

PFS (Progression-Free Survival)

PFS is the time from the date of the first dose until the date of documented radiographic disease progression or death (by any cause in the absence of progression).

Time frame
Up to 2 years
4

OS (Overall Survival)

OS is the time from the date of the first dose until the date of death by any cause.

Time frame
Up to 3 years

Other outcomes

1

Exploratory purposes

The correlation between biomarkers such as PD-L1 subtype, Fudan subtype, HIM subtype, immune microenvironment subtype, and therapeutic efficacy.

Time frame
Up to 3 years

Sponsors and contacts

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