NCT05780034

A Study of AC676 for the Treatment of Relapsed/Refractory B-Cell Malignancies

A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Malignancy Activity of AC676 in Patients With Relapsed/Refractory B-cell Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Accutar Biotechnology Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is evaluating a drug called AC676 in participants with Relapsed/Refractory B-cell Malignancies. The main goals of the study are to: * Identify the recommended dose of AC676 that can be given safely to participants * Evaluate the safety profile of AC676 * Evaluate the pharmacokinetics of AC676 * Evaluate the effectiveness of AC676

Detailed description

AC676-001 is a Phase I, first-in-human, open-label, multi-center dose-escalation study of AC676 given as a single agent. AC676 is an investigational medicinal product that is an orally bioavailable BTK degrader for the treatment of B-cell malignancies.

Conditions

• Relapsed/Refractory B-cell Malignancies

Interventions

Type	Name	Description
DRUG	AC676	AC676 will be given orally (PO) on a 28-day cycle.

Timeline

• Start date: 2023-06-20
• Primary completion: 2026-03-31
• Completion: 2026-05-31
• First posted: 2023-03-22
• Last updated: 2025-10-02

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study