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Phase I Study of EOC202 Plus Paclitaxel in Chinese Patients With Metastatic Breast Cancer

NCT03600090 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-03-31

No results posted yet for this study

Summary

Open label, single arm, dose-escalation phase I study in ambulatory patients receiving first line chemotherapy for metastatic breast cancer. The treatment comprises of the standard 6 cycles of weekly paclitaxel (80 mg/m² IV at D1, D8 and D15 of a 28 day cycle) and two EOC202 doses (6 and 30 mg SC at D2 and D16 of a 28 day cycle) for 6 cycles. After completion of the combined therapy, the patients can continue to receive up to 6 cycles of EOC202 maintenance monotherapy (once every cycle on day 1 of each cycle).

Conditions

  • Solid Tumor, Adult

Interventions

BIOLOGICAL

EOC202

EOC202 will be SC injection.

DRUG

Paclitaxel

Paclitaxol will be IV injection

Sponsors & Collaborators

  • Taizhou EOC Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xichun Hu, M.D. · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2021-12-25
Completion
2021-12-25

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03600090 on ClinicalTrials.gov