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A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.

Primary Purpose

HER2 Low Advanced or Metastatic Breast Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SHR-A1811 & Dalpiciclib Isethionate Tablets
SHR-A1811 & Fulvestrant
SHR-A1811 & Bevacizumab injection
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2 Low Advanced or Metastatic Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements When signing the informed consent, the age is 18-75 years old (including both ends), female patients who have pathologically documented HER2 low breast cancer ECOG Performance Status of 0 or 1 Patient must have adequate tumor sample for biomarker assessment At least one measurable lesion Adequate organ function Exclusion Criteria: There are untreated or active central nervous system (CNS) tumor metastases There was a third space effusion that could not be controlled by drainage (such as a large number of ascites, pleural effusion and pericardial effusion) Major surgery within 4 weeks prior to enrollment Has multiple primary malignancies within 5 years, excluding cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, etc Has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out at screening Uncontrolled intercurrent illness Uncontrolled or significant cardiovascular disease Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. According to NCI-CTCAE v5.0 classification, those who have not recovered to grade Ⅰ toxicity caused by previous anti-tumour treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    SHR-A1811 combined with Dalpiciclib Isethionate Tablets

    SHR-A1811 combined with Fulvestrant

    SHR-A1811 combined with Bevacizumab injection

    Arm Description

    Outcomes

    Primary Outcome Measures

    DLT(Phase I (dose-finding phase) main study endpoint)
    AE(Phase I (dose-finding phase) main study endpoint)
    Incidence and severity of serious adverse events (SAE)(Phase I (dose-finding phase) main study endpoint)
    Objective response rate(The main end points of the second stage (efficacy expansion stage))

    Secondary Outcome Measures

    SHR-A1811 sparse PK concentrations in serum
    Dalpiciclib sparse PK concentrations in plasm
    Incidence of anti-drug antibodies (ADA) to SHR-A1811 over time
    Incidence of neutralizing antibody (NAb) to SHR-A1811 over time
    Duration of response (DoR)
    Progression-free survival (PFS)

    Full Information

    First Posted
    February 17, 2023
    Last Updated
    March 19, 2023
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05792410
    Brief Title
    A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
    Official Title
    An Open, Multicenter Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Dalpiciclib, Fulvestrant, Bevacizumab or Letrozole/Anastrozole in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    February 27, 2024 (Anticipated)
    Study Completion Date
    February 27, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jiangsu HengRui Medicine Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study aims to evaluate the safety, tolerability, PK and preliminary anti-tumour activity of SHR-A1811 combined with other therapies in patients with HER2 low advanced or metastatic breast cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HER2 Low Advanced or Metastatic Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    An open, multicenter, dose-finding and dose expansion investigational Phase IB/II clinical trial
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SHR-A1811 combined with Dalpiciclib Isethionate Tablets
    Arm Type
    Experimental
    Arm Title
    SHR-A1811 combined with Fulvestrant
    Arm Type
    Experimental
    Arm Title
    SHR-A1811 combined with Bevacizumab injection
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    SHR-A1811 & Dalpiciclib Isethionate Tablets
    Intervention Description
    SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Dalpiciclib Isethionate Tablets:Tablet, 25mg / tablet, 50mg / tablet, 125mg / tablet, 150mg / tablet, oral
    Intervention Type
    Drug
    Intervention Name(s)
    SHR-A1811 & Fulvestrant
    Intervention Description
    SHR-A1811:Lyophilized powder injection, 100mg / bottle, intramuscular Fulvestrant:Injection, 5 ml: 0.25g/bottle, intramuscular
    Intervention Type
    Drug
    Intervention Name(s)
    SHR-A1811 & Bevacizumab injection
    Intervention Description
    SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Bevacizumab injection: injection, 100mg / bottle, intravenous drip
    Primary Outcome Measure Information:
    Title
    DLT(Phase I (dose-finding phase) main study endpoint)
    Time Frame
    At the end of cycle 1(each cycle is 28 days for SHR-A1811+ fulvestrant; each cycle is 21 days for SHR-A1811+other therapies.
    Title
    AE(Phase I (dose-finding phase) main study endpoint)
    Time Frame
    Up to follow-up period, approximately 24 months
    Title
    Incidence and severity of serious adverse events (SAE)(Phase I (dose-finding phase) main study endpoint)
    Time Frame
    Up to follow-up period, approximately 24 months
    Title
    Objective response rate(The main end points of the second stage (efficacy expansion stage))
    Time Frame
    Until progression, assessed up to approximately 24 months
    Secondary Outcome Measure Information:
    Title
    SHR-A1811 sparse PK concentrations in serum
    Time Frame
    While on study drug up to study completion, approximately 24 months
    Title
    Dalpiciclib sparse PK concentrations in plasm
    Time Frame
    While on study drug up to study completion, approximately 24 months
    Title
    Incidence of anti-drug antibodies (ADA) to SHR-A1811 over time
    Time Frame
    Up to follow-up period, approximately 24 months
    Title
    Incidence of neutralizing antibody (NAb) to SHR-A1811 over time
    Time Frame
    Up to follow-up period, approximately 24 months
    Title
    Duration of response (DoR)
    Time Frame
    Until progression or death, assessed up to approximately 24 months
    Title
    Progression-free survival (PFS)
    Time Frame
    Until progression or death, assessed up to approximately 24 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements When signing the informed consent, the age is 18-75 years old (including both ends), female patients who have pathologically documented HER2 low breast cancer ECOG Performance Status of 0 or 1 Patient must have adequate tumor sample for biomarker assessment At least one measurable lesion Adequate organ function Exclusion Criteria: There are untreated or active central nervous system (CNS) tumor metastases There was a third space effusion that could not be controlled by drainage (such as a large number of ascites, pleural effusion and pericardial effusion) Major surgery within 4 weeks prior to enrollment Has multiple primary malignancies within 5 years, excluding cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, etc Has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out at screening Uncontrolled intercurrent illness Uncontrolled or significant cardiovascular disease Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. According to NCI-CTCAE v5.0 classification, those who have not recovered to grade Ⅰ toxicity caused by previous anti-tumour treatment
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shuchao Wu
    Phone
    +0518-81220121
    Email
    shuchao.wu@hengrui.com.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.

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