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Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRemeGen Co., Ltd.

About this trial

Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily agree to participate in the study and sign the informed consent form

Stage III unresectable locally advanced or Stage IV metastatic breast cancer.

Subjects must be willing and able to provide a tumor tissue block and/or unstained pathology slides, with priority given to the most recent metastatic lesions that have not previously been subjected to radiotherapy. If this is not feasible or available, then a tumor tissue block (or fresh tissue sections) obtained from locally recurrent lesions should be provided. Freshly obtained tissue is preferred over archived tissue. The provided tissue will be used for biomarker testing and must be suitable for analysis of HER2 expression and PD-L1 expression

Invasive breast tumor tissue has been confirmed as HER2 low expression by the central laboratory

Disqualifiers

Having previously received anti-HER2 treatment, including ADC (Antibody-Drug Conjugates).

Having previously received immunotherapy, including anti PD-(L)1 or anti PD-(L)2 drugs, or drugs that directly target another stimulatory or co-inhibitory T-cell receptor (such as CD137, CTLA-4, OX-40) during the locally advanced or metastatic stage (except if the last administration was ≥12 months prior to recurrence or progression, using [neo]adjuvant anti PD-(L)1).

Use of investigational drugs or undergoing major surgery within 4 weeks prior to the first dose of study medication

Received or plan to receive live vaccines or attenuated live vaccines within 4 weeks prior to the first dose of study medication or during the study period

Trial design

Design model

Parallel

Treatments tested in this trial

  • Disitamab Vedotin

    Drug

    Disitamab Vedotin 2.0mg/kg,intravenous infusion, every 2 weeks

  • RC148

    Drug

    20mg/kg, intravenous infusion, once every 2 weeks

  • Albumin-bound Paclitaxone

    Drug

    125 mg/m2,intravenous infusion, D1-8, every 3 weeks

  • Toripalimab

    Drug

    240mg,intravenous infusion, once every 3 weeks

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Disitamab Vedotin +RC148Experimental treatment 2 interventions
Group B: Albumin-bound Paclitaxone OR Albumin-bound Paclitaxone +ToripalimabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

ORR

The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR per RECIST v1.1

Time frame
24 months

Secondary outcomes

1

PFS

Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first

Time frame
From the first dose to the first documentation of disease progression or death, up to two years
2

DCR

The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1

Time frame
24 months
3

OS

OS is the time from randomization to death due to any cause safety

Time frame
up to 5 years

Other outcomes

Sponsors and contacts

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

RemeGen Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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