Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06543056
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
A Study of ES014 in Subjects With Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Single-arm Phase 2 Study of ES014 in Subjects With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OVERALL DESIGN This study is an open-label single-center single-arm phase 2 clinical study designed to evaluate the efficacy safety and tolerability of ES014 in adults with advanced solid tumors Adult patients with unresectable locally advanced or metastatic solid tumors will be enrolled in this study This study is not blinded
Subject type and number The study population will be adults with unresectable locally advanced or metastatic solid tumors whose disease has progressed despite standard therapy and for whom no further standard therapy exists or for whom standard therapy has proven to be ineffective or intolerable
This study is expected to enroll no more than 15 subjects including malignant pleural mesothelioma and myxofibrosarcoma 4-5 respectively 2-3 malignant peripheral nerve sheath tumors and other solid tumors
Duration of treatment Subjects will be treated with ES014 in 28-day cycles ES014 will be administered at 1400 mg on days 1 and 15 of each cycle Each subject will be treated with study drug for a maximum of 24 months Subjects will be treated according to protocol until disease progression per RECIST v11 development of unacceptable toxicity withdrawal of consent completion of study treatment of 24 months end of study or early termination of study by sponsor or other discontinuation and withdrawal reason whichever occurs first
Subject type and number The study population will be adults with unresectable locally advanced or metastatic solid tumors whose disease has progressed despite standard therapy and for whom no further standard therapy exists or for whom standard therapy has proven to be ineffective or intolerable
This study is expected to enroll no more than 15 subjects including malignant pleural mesothelioma and myxofibrosarcoma 4-5 respectively 2-3 malignant peripheral nerve sheath tumors and other solid tumors
Duration of treatment Subjects will be treated with ES014 in 28-day cycles ES014 will be administered at 1400 mg on days 1 and 15 of each cycle Each subject will be treated with study drug for a maximum of 24 months Subjects will be treated according to protocol until disease progression per RECIST v11 development of unacceptable toxicity withdrawal of consent completion of study treatment of 24 months end of study or early termination of study by sponsor or other discontinuation and withdrawal reason whichever occurs first
Detailed Description:
Subject type and number The study population will be adults with unresectable locally advanced or metastatic solid tumors whose disease has progressed despite standard therapy and for whom no further standard therapy exists or for whom standard therapy has proven to be ineffective or intolerable
Cohort A malignant pleural mesothelioma
Cohort B Mucinous fibrosarcoma
Cohort C Malignant peripheral nerve sheath tumour
Cohort D Other solid tumours
This study is expected to enroll no more than 15 subjects including malignant pleural mesothelioma and myxofibrosarcoma 4-5 respectively 2-3 malignant peripheral nerve sheath tumors and other solid tumors
Duration of treatment Subjects will be treated with ES014 in 28-day cycles ES014 will be administered at 1400 mg on days 1 and 15 of each cycle Each subject will be treated with study drug for a maximum of 24 months Subjects will be treated according to protocol until disease progression per RECIST v11 development of unacceptable toxicity withdrawal of consent completion of study treatment of 24 months end of study or early termination of study by sponsor or other discontinuation and withdrawal reason whichever occurs first
Cohort A malignant pleural mesothelioma
Cohort B Mucinous fibrosarcoma
Cohort C Malignant peripheral nerve sheath tumour
Cohort D Other solid tumours
This study is expected to enroll no more than 15 subjects including malignant pleural mesothelioma and myxofibrosarcoma 4-5 respectively 2-3 malignant peripheral nerve sheath tumors and other solid tumors
Duration of treatment Subjects will be treated with ES014 in 28-day cycles ES014 will be administered at 1400 mg on days 1 and 15 of each cycle Each subject will be treated with study drug for a maximum of 24 months Subjects will be treated according to protocol until disease progression per RECIST v11 development of unacceptable toxicity withdrawal of consent completion of study treatment of 24 months end of study or early termination of study by sponsor or other discontinuation and withdrawal reason whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None