Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-03-11 @ 5:24 PM
Study NCT ID:
NCT06756035
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2024-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT-95 in Advanced Cancers Associated With Mesothelin Expression
Sponsor:
Context Therapeutics Inc.
Organization:
Study Overview
Official Title:
Phase 1a/1b Study of CT-95 in Advanced Cancers Associated With Mesothelin Expression
Status:
RECRUITING
Status Verified Date:
2025-07
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:
This is a Phase 1a/1b open-label, dose escalation study to evaluate the safety and efficacy of CT-95 (study drug), a humanized T cell engaging bispecific antibody targeting Mesothelin, in subjects with advanced solid tumors associated with Mesothelin expression.
Detailed Description:
The Phase 1a Dose Escalation portion of the trial will enroll subjects in one of approximately 8 dose escalation cohorts to assess the safety and tolerability of CT-95, as well as determine the maximum tolerated dose (MTD) or other recommended dose(s) for expansion (RDE\[s\]) for further study in 2 dose optimization cohorts. Subjects will receive CT-95 as a single agent administered once weekly (QW) intravenously (IV) over a 4-week cycle.
The Phase 1b Dose Expansion portion will evaluate CT-95 in indication-specific expansion cohorts
The Phase 1b Dose Expansion portion will evaluate CT-95 in indication-specific expansion cohorts
Study Oversight
Has Oversight DMC:
False
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?: