Ignite Creation Date:
2024-10-25 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547840
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
A Study of MOv18 IgE in Folate Receptor Alpha-expressing Platinum Resistant Ovarian Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase Ib Open-Label Trial of MOv18 IgE in Patients With Advanced Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
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:
EPS101-10-02 is a Phase Ib open label multicentre clinical trial comprising of a Dose Escalation phase Part 1 followed by a Dose Expansion phase Part 2 of MOv18 IgE in patients with folate receptor alpha-expressing 5 or higher platinum resistant ovarian cancer
The dose escalation part of the study will primarily assess the safety and tolerability of MOv18 IgE in ascending dose cohorts until the determination of the maximum tolerated dose MTD or maximum administered dose MAD
Part 2 dose expansion will further assess the safety tolerability and anti-tumour activity of MOv18 IgE
The dose escalation part of the study will primarily assess the safety and tolerability of MOv18 IgE in ascending dose cohorts until the determination of the maximum tolerated dose MTD or maximum administered dose MAD
Part 2 dose expansion will further assess the safety tolerability and anti-tumour activity of MOv18 IgE
Detailed Description:
EPS101-10-02 is a two-part Phase Ib open-label dose escalation and expansion trial in patients with platinum resistant ovarian cancer whose disease has progressed after no more than 4 lines of standard therapy
In total the trial will enrol approximately 45 patients All enrolled patients will have biopsy accessible measurable disease with a confirmed FRĪ± expression of 5 or higher
MOv18 IgE will be administered to approximately 30 patients in Part 1 and up to a further 15 in Part 2
Patients will receive treatment on Days 1 8 and 15 of a 21-day cycle and may continue treatment until radiological disease progression or unacceptable toxicity despite optimal medical management or dose or schedule modification or withdrawal of consent
The starting dose of MOv18 IgE is 3 mg
Patient screening will occur during the 28 days prior to the first administration of MOv18 IgE All patients will undergo PK PD and safety assessments as well as disease response tumour assessments to determine the potential clinical benefit of MOv18 IgE In all instances patients will be followed up for overall survival OS for a maximum of 270 days after their last dose of trial treatment or until withdrawal of consent lost to follow-up death or the overall end of trial whichever is earliest
In Part 1 MOv18 IgE will be administered at increasing dose levels in different patient cohorts of approximately 6 patients until selection of the Part 2 dose The dose of MOv18 IgE administered in Part 1 will be escalated following a Bayesian logistic regression model - Escalation with overdose control BLRM-EWOC trial design
After determination of the Part 2 dose up to 15 additional patients will be enrolled and treated with MOv18 IgE at that dose to further assess anti-tumour activity of MOv18 IgE and obtain additional information on its safety PK and PD
In total the trial will enrol approximately 45 patients All enrolled patients will have biopsy accessible measurable disease with a confirmed FRĪ± expression of 5 or higher
MOv18 IgE will be administered to approximately 30 patients in Part 1 and up to a further 15 in Part 2
Patients will receive treatment on Days 1 8 and 15 of a 21-day cycle and may continue treatment until radiological disease progression or unacceptable toxicity despite optimal medical management or dose or schedule modification or withdrawal of consent
The starting dose of MOv18 IgE is 3 mg
Patient screening will occur during the 28 days prior to the first administration of MOv18 IgE All patients will undergo PK PD and safety assessments as well as disease response tumour assessments to determine the potential clinical benefit of MOv18 IgE In all instances patients will be followed up for overall survival OS for a maximum of 270 days after their last dose of trial treatment or until withdrawal of consent lost to follow-up death or the overall end of trial whichever is earliest
In Part 1 MOv18 IgE will be administered at increasing dose levels in different patient cohorts of approximately 6 patients until selection of the Part 2 dose The dose of MOv18 IgE administered in Part 1 will be escalated following a Bayesian logistic regression model - Escalation with overdose control BLRM-EWOC trial design
After determination of the Part 2 dose up to 15 additional patients will be enrolled and treated with MOv18 IgE at that dose to further assess anti-tumour activity of MOv18 IgE and obtain additional information on its safety PK and PD
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