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NCT04996875 · ClinicalTrials.gov registry record · Phase 2

(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

A Phase 2 study of Advanced Systemic Mastocytosis (AdvSM) and SM With an Associated Hematologic Neoplasm (SM-AHN), sponsored by Cogent Biosciences.

Recruiting
Registry status
Phase 2
Development phase
140
Enrollment target
20
Study locations

NCT04996875 is a Phase 2 study of Advanced Systemic Mastocytosis (AdvSM) and SM With an Associated Hematologic Neoplasm (SM-AHN) that is actively recruiting participants, run by Cogent Biosciences. The registered enrollment target is 140 participants. The trial reports 20 study locations across 17 states.

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The verdict

NCT04996875, a Phase 2 study of Advanced Systemic Mastocytosis (AdvSM) and SM With an Associated Hematologic Neoplasm (SM-AHN), is actively recruiting participants, sponsored by Cogent Biosciences.

RECRUITING
Registry status
Phase 2
Development phase
140 participants
Enrollment target
20
Study locations

Study Summary

This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).

Interventions

  • DRUG bezuclastinib

Study Locations (20)

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • UCLA Medical Center - Los Angeles
  • Stanford Cancer Institute - Stanford

Other

  • AKH Wien, Universitatsklinikum - Vienna
  • CHU de Liege - Liège

Alabama

  • University of Alabama at Birmingham (UAB) Hospital - Birmingham

Arizona

  • Mayo Clinic Arizona - Phoenix

Florida

  • Galiz Research - Hialeah

Georgia

  • Winship Cancer Institute - Emory University - Atlanta

Illinois

  • Rush University Medical Center - Chicago

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Trial Details

FieldValue
Enrollment Target 140 participants
Start Date 2021-11-09
Est. Completion 2026-07
Phase Phase 2

Sponsor

Cogent Biosciences

12 total trials

What the Registry Record Tells You About NCT04996875

The ClinicalTrials.gov registry entry for NCT04996875 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cogent Biosciences, which has 12 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Advanced Systemic Mastocytosis (AdvSM) appearing as the primary indexed condition, and to 1 intervention - of which bezuclastinib is the first listed.

NCT04996875 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, Other, Alabama.

Frequently Asked Questions

What is clinical trial NCT04996875 about?

NCT04996875 is a clinical study titled "(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis". This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).

What is the current status of trial NCT04996875?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2021-11-09. Estimated completion is 2026-07.

What conditions does trial NCT04996875 study?

This clinical trial studies the following conditions: Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN), Mast Cell Leukemia (MCL), Aggressive Systemic Mastocytosis (ASM).

What interventions are being tested in trial NCT04996875?

The interventions under investigation include: bezuclastinib (DRUG).

Who is sponsoring clinical trial NCT04996875?

This trial is sponsored by Cogent Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04996875 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.