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B003 in Patients With HER2-positive Recurrent or Metastatic Breast Cancer

NCT03953833 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-09-14

No results posted yet for this study

Summary

To assess the safety and tolerability characteristics of B003 in HER2-positive patients with recurrent or metastatic breast cancer. The dose-limiting toxicity (DLT) is assessed and the maximum tolerated dose (MTD) is explored.

Conditions

Interventions

BIOLOGICAL

Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003.

Usage: Intravenous infusion; Dose escalation stage: doses 0.6, 1.2, 2.4, 3.6, 4.8 mg / kg, 1-6subjects each. Dose expansion stage: 20 subjects are enrolled and take the recommended dose based on the result of dose escalation stage. Infusion time：90 minutes(90min-106min suggested) for the first time; if no infusion reaction happens, the follow-up time is adjusted to at least30 minutes(30min-40min suggested).Dose escalation stage: treatment cycle is administered every 21days,the infusion is taken at the first day of each treatment cycle.Observation period of DLT is the 21st day of the first treatment cycle.

Sponsors & Collaborators

  • Shanghai Pharmaceuticals Holding Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yu Jiang · West China Hospital

  • Yongsheng Wang · West China Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2023-01-13
Completion
2023-01-13

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03953833 on ClinicalTrials.gov