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Study of ADCs Combined With Adebrelimab in HER2-negative Advanced Breast Cancer

ConditionAdvanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing GoBroad Hospital

About this trial

Our study is aimed to evaluate the efficacy and safety of novel ADCs named SHR-A1811, SHR-A1921 and SHR-A2102 combined with adebrelimab in HER2-negative advanced breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years to 75 years old (including boundary values);

ECOG PS Score: 0~1;

Histologically or cytologically confirmed HER2-negative advanced breast cancer;

Disease progression after prior ≥1 line of systemic therapy; if HR-positive, prior CDK4/6 inhibitor is necessary;

Disqualifiers

Has known active brain metastasis which needs local therapy immediately;

Prior use of ADCs with the same target as study drugs;

Existence of third space fluid that is not well controlled by effective methods, e.g. drainage;

Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy or immunological therapy within 4 weeks before first dose of study therapy; has received antitumor endocrine therapy within one week before first dose of study therapy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-A1811

    Drug

    Via intravenous infusion

  • SHR-A1921

    Drug

    Via intravenous infusion

  • Adebrelimab

    Drug

    Via intravenous infusion

  • SHR-A2102

    Drug

    Via intravenous infusion

Treatment groups

113 Participants
are divided into 3 treatment groups
Group A: SHR-A1811+adebrelimabExperimental treatment 2 interventions
Group B: SHR-A1921+adebrelimabExperimental treatment 2 interventions
Group C: SHR-A2102 + adebrelimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

ORR (objective response rate) by investigator

ORR 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
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years

Secondary outcomes

1

DCR (disease control rate) by investigator

DCR 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
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
2

CBR (clinical benefit rate) by investigator

CBR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD lasting≥24 weeks (stable disease) per RECIST v1.1.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years
3

DoR (duration of response)

DoR is the time from the date of first detection of objective response (which is subsequently confirmed) until the date of objective radiographic disease progression.

Time frame
up to 3.5 years
4

PFS (progression-free survival)

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

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3.5 years

Other outcomes

Sponsors and contacts

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

Beijing GoBroad Hospital

Lead sponsor

Source ClinicalTrials.gov
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