A Multi-center, Open-lable, Single-arm Phase II Study to Evaluate the Efficacy and Safety of DP303c in Patients With HER2-positive Unresectable Locally Advanced, Relapsed, or Metastatic Breast Cancer

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.0 sites191 target enrollmentMay 1, 2022

ConditionsHER2-positive Breast Cancer

InterventionsDP303c

DrugsDP303c

Overview

Phase: Phase 2
Intervention: DP303c
Conditions: HER2-positive Breast Cancer
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Enrollment: 191
Primary Endpoint: Objective Response Rate (ORR)
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a study of DP303c in patients with HER2-positive advanced breast cancer.

Detailed Description

This is a multi-center, open-lable, single-arm Phase II study to evaluate the efficacy and safety of DP303c in patients with HER2-positive unresectable locally advanced, relapsed, or metastatic breast cancer. Patients will be treated with DP303c injection at 3.0 mg/kg every 3 weeks. Patients will receive DP303c until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.

Registry

clinicaltrials.gov

Start Date

May 1, 2022

End Date

December 31, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntary agreement to provide written informed consent;
•Aged 18 to 75 years, male or female;
•Patients with unresectable locally advanced, relapsed, or metastatic breast cancer confirmed by histology or cytology;
•Received at least 2 lines of systemic anti-HER2 therapy for unresectable locally advanced, recurrent, or metastatic disease, and one of which is a trastuzumab-containing regimen, progression during or within 12 months of the end of prior (neo)adjuvant anti-HER2 therapy is considered one line of therapy.
•Radiographic evidence of disease progression confirmed by the investigator during or after the most recent systemic treatment;
•Sufficient tumor samples within 3 years are available for central lab to confirm the HER2 status;
•Confirmed to be HER2 positive by central lab (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive);
•At least one measurable target lesion at the baseline according to the RECIST v1.1;
•The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
•Left ventricular ejection fraction (LVEF) ≥50% of normal in echocardiogram (ECHO) or multi-gate detection scan (MUGA) within 4 weeks before the first administration of study drug;

Exclusion Criteria

•Pregnant or breastfeeding women；
•History of DP303c treatment;
•History of any other malignant tumors within five years (except for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ and other in situ tumors that have received radical resection and have not recurred);
•Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ grade 1 or baseline (refer to NCI CTCAE 5.0) (except for adverse reaction such as alopecia, pigmentation disorder and others which have no safety risk evaluated by the investigator);
•Patients have received other clinical trial drugs within 4 weeks before the first dose of study drug (for small molecule targeted drugs, this time interval is required to be 2 weeks or 5 half-lives, whichever is longer);
•Cytotoxic chemotherapy, radiotherapy and immunotherapy and other anti-tumor treatments within 4 weeks before the first dose of study drug; endocrine therapy and Chinese medicine treatments with anti-tumor indications within 2 weeks; or oral fluorouracil and small molecule targeted drugs within 2 weeks or 5 half-lives, whichever is longer;
•Radical radiation therapy within 4 weeks before the first dose of study drug or palliative radiation therapy within 2 weeks before the first dose of study drug;
•Underwent major surgery within 4 weeks and did not fully recover before the first dose of study drug;
•The cumulative amount of previous exposure to anthracyclines has reached the following dosage: doxorubicin or liposomal doxorubicin \>360 mg/m\^2; epirubicin \>720 mg/m\^2; mitoxantrone\>120 mg/m\^2; idarubicin \>90 mg/m\^2; or other anthracyclines \> 360 mg/m\^2 of doxorubicin equivalent;
•Untreated (including baseline findings) or unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis.