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

March 19, 2023 updated by: Jiangsu HengRui Medicine Co., Ltd.

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. 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
  2. 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
  3. ECOG Performance Status of 0 or 1
  4. Patient must have adequate tumor sample for biomarker assessment
  5. At least one measurable lesion
  6. Adequate organ function

Exclusion Criteria:

  1. There are untreated or active central nervous system (CNS) tumor metastases
  2. 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)
  3. Major surgery within 4 weeks prior to enrollment
  4. Has multiple primary malignancies within 5 years, excluding cured basal cell carcinoma of skin, cervical carcinoma in situ, papillary thyroid carcinoma, etc
  5. Has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out at screening
  6. Uncontrolled intercurrent illness
  7. Uncontrolled or significant cardiovascular disease
  8. Has known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
  9. According to NCI-CTCAE v5.0 classification, those who have not recovered to grade Ⅰ toxicity caused by previous anti-tumour treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-A1811 combined with Dalpiciclib Isethionate Tablets
Drug: SHR-A1811 & Dalpiciclib Isethionate Tablets
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Dalpiciclib Isethionate Tablets：Tablet, 25mg / tablet, 50mg / tablet, 125mg / tablet, 150mg / tablet, oral
Experimental: SHR-A1811 combined with Fulvestrant
Drug: SHR-A1811 & Fulvestrant
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intramuscular Fulvestrant：Injection, 5 ml: 0.25g/bottle, intramuscular
Experimental: SHR-A1811 combined with Bevacizumab injection
Drug: SHR-A1811 & Bevacizumab injection
SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Bevacizumab injection: injection, 100mg / bottle, intravenous drip

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.
AE(Phase I (dose-finding phase) main study endpoint)
Time Frame: Up to follow-up period, approximately 24 months
Up to follow-up period, approximately 24 months
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
Up to follow-up period, approximately 24 months
Objective response rate(The main end points of the second stage (efficacy expansion stage))
Time Frame: Until progression, assessed up to approximately 24 months
Until progression, assessed up to approximately 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
SHR-A1811 sparse PK concentrations in serum
Time Frame: While on study drug up to study completion, approximately 24 months
While on study drug up to study completion, approximately 24 months
Dalpiciclib sparse PK concentrations in plasm
Time Frame: While on study drug up to study completion, approximately 24 months
While on study drug up to study completion, approximately 24 months
Incidence of anti-drug antibodies (ADA) to SHR-A1811 over time
Time Frame: Up to follow-up period, approximately 24 months
Up to follow-up period, approximately 24 months
Incidence of neutralizing antibody (NAb) to SHR-A1811 over time
Time Frame: Up to follow-up period, approximately 24 months
Up to follow-up period, approximately 24 months
Duration of response (DoR)
Time Frame: Until progression or death, assessed up to approximately 24 months
Until progression or death, assessed up to approximately 24 months
Progression-free survival (PFS)
Time Frame: Until progression or death, assessed up to approximately 24 months
Until progression or death, assessed up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

February 27, 2024

Study Completion (Anticipated)

February 27, 2025

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

March 19, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 31, 2023

Last Update Submitted That Met QC Criteria

March 19, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-A1811-206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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