Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657222
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter FIH Dose Escalation and Optimization Phase IIIa Trial to Investigate Safety Tolerability PK and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors 5-STAR 1-01
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults The study will also explore the safety of TUB-030 The main questions it aims to answer are
To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types in patients with head and neck cancer and patients with non-small cell lung cancer to see if TUB-030 works to treat these two solid cancer types and to determine the best dose
Participants will
Receive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms
To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types in patients with head and neck cancer and patients with non-small cell lung cancer to see if TUB-030 works to treat these two solid cancer types and to determine the best dose
Participants will
Receive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None