Ignite Creation Date:
2024-07-17 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478693
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-24
Brief Title:
A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers Including HCC
Sponsor:
Myeloid Therapeutics
Organization:
Myeloid Therapeutics
Study Overview
Official Title:
A Phase 1 Open-Label First-in-Human Dose Escalation Study to Investigate the Safety Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers Including Hepatocellular Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-08
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 multicenter open-label Phase 1 first-in-human dose-escalation study designed to assess the safety tolerability and define the RP2D of MT-303 in participants with advanced hepatocellular carcinoma expressing GPC3
Detailed Description:
MT-303 will be administered intravenously with treatment provided until lack of tolerability or progression Participants will be enrolled in sequential dose escalation cohorts with determination of dose limiting toxicities with the goal of establishing the maximum tolerated dose MTD and Recommended Phase 2 dose RP2D
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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