Trials / Recruiting

RecruitingNCT06911333

AD1208 in Subjects With Any Progressive, Locally Advanced or Metastatic Solid Tumors

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
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 36 (estimated)

Sponsor: Avelos Therapeutics Inc. · Industry
Sex: All
Age: 19 Years
Healthy volunteers: Not accepted

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

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.

Conditions

Interventions

Type	Name	Description
DRUG	AD1208	Up to 6 of cohorts will be applied sequentially in phase Ia part.

Timeline

Start date: 2025-03-11
Primary completion: 2029-06-30
Completion: 2030-02-20
First posted: 2025-04-04
Last updated: 2025-04-04

Locations

3 sites across 1 country: South Korea

Source: ClinicalTrials.gov record NCT06911333. Inclusion in this directory is not an endorsement.