Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06150664
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-11-17
Brief Title:
A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
Sponsor:
Compass Therapeutics
Organization:
Compass Therapeutics
Study Overview
Official Title:
A Phase 1 Open-Label Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced Malignancies
Status:
RECRUITING
Status Verified Date:
2023-10
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 1 open-label first-in-human study of CTX-8371 administered as a monotherapy in patients with metastatic or locally advanced malignancies The study will be conducted in 2 cohorts Dose Escalation and Dose Expansion
Detailed Description:
This Phase 1 open-label first-in-human study will evaluate the safety tolerability immunogenicity and pharmacokinetic profile of CTX-8371 monotherapy Preliminary anti-tumor activity of CTX-8371 will also be assessed The study will be conducted in 2 cohorts Dose escalation and Dose expansion The Dose Escalation Cohort will utilize a 33 design to evaluate five dose levels 01-10 mgkg of CTX-8371 given as an IV infusion once every 2 weeks Patients in the Dose Expansion Cohort will receive CTX-8371 as an IV infusion at a doses based on data from the Dose Escalation Cohort
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None