Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT05337735
Status:
SUSPENDED
Last Update Posted:
2025-10-09
First Post:
2022-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Clinical Trial to Evaluate Safety and Efficacy of XmAb20717 in Advanced Rare Cancers
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Clinical Trial to Evaluate Safety and Efficacy of XmAb20717 in Advanced Rare Cancers
Status:
SUSPENDED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI Request
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To test the safety of and effectiveness of XmAb20717 for participants with advanced rare cancers.
Detailed Description:
Primary Objective:
Efficacy of XmAb20717 as defined by objective response (defined as a complete response \[CR\] or partial response \[PR\] on two consecutive occasions ≥4 weeks apart) as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma)
Secondary Objectives:
1. Objective response as determined by an independent radiologist according to immune-modified RECIST
2. Progression-free survival (PFS) (defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first) as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma).
3. Duration of response (DoR) (defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first) as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma)
4. Disease control as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma)
5. Overall survival (OS) (defined as the time from enrollment to death from any cause)
6. PFS as determined by an independent radiologist according to immune-modified RECIST
7. DoR as determined by an independent radiologist according to immune-modified RECIST
8. Disease control as determined by an independent radiologist according to immune-modified RECIST
9. Occurrence and severity of AEs, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0
Exploratory Objective
To identify biomarkers that are predictive of response and/or are associated with progression to a more severe disease state (i.e., prognostic biomarkers).
Efficacy of XmAb20717 as defined by objective response (defined as a complete response \[CR\] or partial response \[PR\] on two consecutive occasions ≥4 weeks apart) as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma)
Secondary Objectives:
1. Objective response as determined by an independent radiologist according to immune-modified RECIST
2. Progression-free survival (PFS) (defined as the time from enrollment to the first occurrence of disease progression or death from any cause, whichever occurs first) as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma).
3. Duration of response (DoR) (defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first) as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma)
4. Disease control as determined by an independent radiologist according to RECIST v1.1 (modified RECIST for pleural mesothelioma)
5. Overall survival (OS) (defined as the time from enrollment to death from any cause)
6. PFS as determined by an independent radiologist according to immune-modified RECIST
7. DoR as determined by an independent radiologist according to immune-modified RECIST
8. Disease control as determined by an independent radiologist according to immune-modified RECIST
9. Occurrence and severity of AEs, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0
Exploratory Objective
To identify biomarkers that are predictive of response and/or are associated with progression to a more severe disease state (i.e., prognostic biomarkers).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2022-02841 | OTHER | NCI-CTRP-Clinical Trial Reporting Registry | View |