Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440005
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-26
Brief Title:
A Study to Evaluate Safety Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
Sponsor:
Angiex Inc
Organization:
Angiex Inc
Study Overview
Official Title:
A Phase 1 Open-Label Dose-Escalation and Expansion Study of AGX101 a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors Including Triple-Negative Breast Cancer and Pancreatic Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-09
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:
AGX101 is an antibody-drug conjugate ADC therapy for tumor-forming cancers The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population AGX101will be administered intravenously
Dosing of AGX101 will be repeated once every 3 weeks Participants may continue study treatment until disease progression unacceptable toxicity or consent withdrawal Subjects will attend an end of treatment visit and will receive two safety follow-up telephone contacts up to 90 days following the last dose of study drug
Dosing of AGX101 will be repeated once every 3 weeks Participants may continue study treatment until disease progression unacceptable toxicity or consent withdrawal Subjects will attend an end of treatment visit and will receive two safety follow-up telephone contacts up to 90 days following the last dose of study drug
Detailed Description:
None
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