Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 8:17 PM
Study NCT ID:
NCT06911333
Status:
RECRUITING
Last Update Posted:
2025-04-04
First Post:
2025-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors
Sponsor:
Avelos Therapeutics Inc.
Organization:
Study Overview
Official Title:
A Phase I/IIa Trial of AD1208, a Cell Cycle Inhibitor/MASTL Inhibitor, as a Single Agent or a Combination in Subjects With Any Progressive, Locally Advanced(Unresectable) or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-03
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:
AD1208
Brief Summary:
The goal of this clinical trial is to evaluate the safety and tolerability of AD1208 to determine the maximum tolerated dose(MTD) or maximumly administered dose(MAD) in any progressive, locally advanced (unresectable) or metastatic solid tumors. The main questions it aims to answer are:
* Which dosage of AD1208 is safe and tolerable for participants?
* What medical problems do participants have when taking AD1208?
Participants will:
* Take drug AD1208 every day up to 1 cycle at the least.
* Visit the site once every 1 weeks for checkups and tests during cycle 1 and every 3 weeks from cycle 2 onwards.
* Keep a diary of any adverse events and administrated drug
* Which dosage of AD1208 is safe and tolerable for participants?
* What medical problems do participants have when taking AD1208?
Participants will:
* Take drug AD1208 every day up to 1 cycle at the least.
* Visit the site once every 1 weeks for checkups and tests during cycle 1 and every 3 weeks from cycle 2 onwards.
* Keep a diary of any adverse events and administrated drug
Detailed Description:
\- Dose-escalation Part The treatment cycle is defined as 21 days and AD1208 will be administered orally once or twice a day from Day 1 to Day 21 in every 21-day cycle. The dose-escalation part is divided into phase 1a, which determines the Recommended dose of AD1208 in monotherapy, and phase 1b, which determines the RP2D of AD1208 in combination therapy.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: