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

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT05792410
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • HER2 Low Advanced or Metastatic Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-A1811 & Dalpiciclib Isethionate Tablets — DRUG
    SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Dalpiciclib Isethionate Tablets：Tablet, 25mg / tablet, 50mg / tablet, 125mg / tablet, 150mg / tablet, oral
  • SHR-A1811 & Fulvestrant — DRUG
    SHR-A1811：Lyophilized powder injection, 100mg / bottle, intramuscular Fulvestrant：Injection, 5 ml: 0.25g/bottle, intramuscular
  • SHR-A1811 & Bevacizumab injection — DRUG
    SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Bevacizumab injection: injection, 100mg / bottle, intravenous drip

Study Details

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.

Key Dates

First listed
Mar 31, 2023
Start date
Apr 30, 2023
Status verified
Feb 2023
Primary completion
Feb 27, 2024
Completion
Feb 27, 2025

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-A1811 combined with Dalpiciclib Isethionate Tablets
  • Experimental: SHR-A1811 combined with Fulvestrant
  • Experimental: SHR-A1811 combined with Bevacizumab injection

Primary Outcome Measure

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. ]

Central Contacts