Ignite Creation Date:
2024-05-06 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05322720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-04-12
First Post:
2022-03-10
Brief Title:
HR Positive HER2 Negative Advanced Breast Cancer With Progression After Endocrine Therapy
Sponsor:
Taizhou EOC Pharma Co Ltd
Organization:
Taizhou EOC Pharma Co Ltd
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:
NOT_YET_RECRUITING
Status Verified Date:
2021-08
Last Known Status:
None
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 11
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 11
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 11 randomized into the following two groups for treatment
Experimental group EOC202 30 mg albumin-bound paclitaxel 100 mgm2 Control group albumin-bound paclitaxel 100 mgm2 One cycle of therapy is 4 weeks 28 days the subjects in the experimental group will receive albumin-bound paclitaxel 100 mgm2 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 mgm2 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 11 randomized into the following two groups for treatment
Experimental group EOC202 30 mg albumin-bound paclitaxel 100 mgm2 Control group albumin-bound paclitaxel 100 mgm2 One cycle of therapy is 4 weeks 28 days the subjects in the experimental group will receive albumin-bound paclitaxel 100 mgm2 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 mgm2 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?:
None