Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT05322720
Status:
UNKNOWN
Last Update Posted:
2022-04-12
First Post:
2022-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HR Positive, HER2 Negative Advanced Breast Cancer With Progression After Endocrine Therapy
Sponsor:
Taizhou EOC Pharma Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase II Clinical Study to Evaluate the Safety and Efficacy of Recombinant hLAG-3 Fusion Protein (EOC202) Injection Combined With Albumin-bound Paclitaxel in Treatment of the Patients With HR Positive, HER2 Negative Advanced Breast Cancer With Progression After Endocrine Therapy
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
Overall design:
This is a randomized, open, parallel-controlled study to evaluate the efficacy and safety of EOC202 combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in treatment of the patients with HR positive, HER2 negative advanced breast cancer.
This study plans to enroll 50 patients with HR positive, HER2 negative advanced breast cancer who have progression after endocrine therapy and are suitable for taxane therapy, and these patients will be 1:1 randomized into the following two groups for treatment:
Experimental group: EOC202 30 mg+ albumin-bound paclitaxel (100 mg/m2); Control group: albumin-bound paclitaxel (100 mg/m2). One cycle of therapy is 4 weeks (28 days), the subjects in the experimental group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on Day 1 (D1), D8 and D15 of each cycle, and EOC202 30 mg subcutaneously on D2 and D16 of each cycle; the subjects in the control group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on D1, D8 and D15 of each cycle. The treatment will continue until progression of disease, death, intolerable toxicity, start of other antitumor therapy, withdrawal of informed consent, loss of follow-up or termination of study for other reasons, whichever comes first.
No less than 6 cycles of therapy with albumin-bound paclitaxel will be given on the premise it is tolerable by the subject. For the combined therapy, if it is judged by investigators and approved by the sponsor that albumin-bound paclitaxel needs to be discontinued permanently for toxicity, the subject can continue to receive EOC202; on the contrary, if it is judged by investigators and approved by the sponsor that EOC202 needs to be discontinued permanently for toxicity, the subject can continue to receive albumin-bound paclitaxel.
This is a randomized, open, parallel-controlled study to evaluate the efficacy and safety of EOC202 combined with albumin-bound paclitaxel versus albumin-bound paclitaxel alone in treatment of the patients with HR positive, HER2 negative advanced breast cancer.
This study plans to enroll 50 patients with HR positive, HER2 negative advanced breast cancer who have progression after endocrine therapy and are suitable for taxane therapy, and these patients will be 1:1 randomized into the following two groups for treatment:
Experimental group: EOC202 30 mg+ albumin-bound paclitaxel (100 mg/m2); Control group: albumin-bound paclitaxel (100 mg/m2). One cycle of therapy is 4 weeks (28 days), the subjects in the experimental group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on Day 1 (D1), D8 and D15 of each cycle, and EOC202 30 mg subcutaneously on D2 and D16 of each cycle; the subjects in the control group will receive albumin-bound paclitaxel 100 mg/m2 iv drip on D1, D8 and D15 of each cycle. The treatment will continue until progression of disease, death, intolerable toxicity, start of other antitumor therapy, withdrawal of informed consent, loss of follow-up or termination of study for other reasons, whichever comes first.
No less than 6 cycles of therapy with albumin-bound paclitaxel will be given on the premise it is tolerable by the subject. For the combined therapy, if it is judged by investigators and approved by the sponsor that albumin-bound paclitaxel needs to be discontinued permanently for toxicity, the subject can continue to receive EOC202; on the contrary, if it is judged by investigators and approved by the sponsor that EOC202 needs to be discontinued permanently for toxicity, the subject can continue to receive albumin-bound paclitaxel.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: