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HR Positive, HER2 Negative Advanced Breast Cancer With Progression After Endocrine Therapy

NCT05322720 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-04-12

No results posted yet for this study

Summary

Primary objective:

To evaluate the progression-free survival (PFS) for EOC202 combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in treatment of the patients with HR positive, HER2 negative advanced breast cancer (response evaluation criteria in solid tumors, RECIST 1.1);

Secondary objectives:

1. To evaluate other efficacy variables, such as objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR) and overall survival (OS), for EOC202 combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in treatment of HR positive, HER2 negative advanced breast cancer;
2. To evaluate the safety of EOC202 combined with albumin-bound paclitaxel;
3. To evaluate the immunogenicity of EOC202 combined with albumin-bound paclitaxel;
4. To evaluate the change level of pharmacodynamic (PD) markers (Interferon-γ, CXCL-10).

Exploratory objectives:

To explore the correlation of baseline soluble MHC-II ligands in blood (lymphocyte activation gene-3 (Lag-3) and fibrin related antigen (FGL-1)) with safety, efficacy, PD and anti-drug antibody (ADA) in subjects in EOC202 combined with albumin-bound paclitaxel group.

Conditions

  • Solid Tumor, Adult

Interventions

BIOLOGICAL

EOC202

EOC202 will be SC injection

DRUG

albumin-bound paclitaxel

albumin-bound paclitaxel will be Iv injection

Sponsors & Collaborators

  • Taizhou EOC Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xichun Hu, Ph.D · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2023-03-31
Completion
2025-05-31

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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 NCT05322720 on ClinicalTrials.gov