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NCT04215809 · ClinicalTrials.gov registry record · Phase 1

Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL

A Phase 1 study of CLL/SLL, sponsored by Ascentage Pharma Group.

Recruiting
Registry status
Phase 1
Development phase
144
Enrollment target
9
Study locations

NCT04215809: Recruiting Phase 1 study of CLL/SLL, sponsored by Ascentage Pharma Group.

NCT04215809 is a Phase 1 study of CLL/SLL that is actively recruiting participants, run by Ascentage Pharma Group. The registered enrollment target is 144 participants, above the 103-participant average among 6 other CLL/SLL trials with a reported enrollment target (40% higher). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04215809, a Phase 1 study of CLL/SLL, is actively recruiting participants, sponsored by Ascentage Pharma Group.

RECRUITING
Registry status
Phase 1
Development phase
144 participants
Enrollment target
9
Study locations

Study Summary

Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of lisaftoclax.

Primary Outcome

DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 6 weeks (2 cycles) of study treatment. These will be assessed via CTCAE version 5.0

Conditions Studied

CLL/SLL

Interventions

  • DRUG Lisaftoclax

Study Locations (9)

Ohio

  • Gabrail Cancer Center - Canton
  • Cleveland Clinic - Cleveland

California

  • City of Hope - Duarte

Florida

  • Mayo Clinic - Jacksonville

Massachusetts

  • Dana Farber Cancer Institute - Boston

North Carolina

  • Novant Health - Charlotte

Washington

  • Swedish Health - Seattle

Queensland

  • Princess Alexandria Hospital - Brisbane

Victoria

  • Frankston Private Hospital - Melbourne

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2020-03-02
Est. Completion 2027-06-30
Phase Phase 1
Ascentage Pharma Group

15 total trials

What NCT04215809 shows while recruiting

NCT04215809 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, above the 103-participant average among 6 other CLL/SLL trials with a reported enrollment target (40% higher).

The record links to 1 condition, with CLL/SLL appearing as the primary indexed condition, and to 1 intervention - of which Lisaftoclax is the first listed.

NCT04215809 lists 9 locations in 8 states (Ohio, California, Florida).

Frequently Asked Questions

What is clinical trial NCT04215809 about?

NCT04215809 is a clinical study titled "Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL". Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of lisaftoclax.

What is the current status of trial NCT04215809?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2020-03-02. Estimated completion is 2027-06-30.

What conditions does trial NCT04215809 study?

This clinical trial studies the following conditions: CLL/SLL.

What interventions are being tested in trial NCT04215809?

The interventions under investigation include: Lisaftoclax (DRUG).

Who is sponsoring clinical trial NCT04215809?

This trial is sponsored by Ascentage Pharma Group, which has 15 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04215809 being conducted?

This trial has 9 study locations across California, Florida, Massachusetts, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT04215809

Source: ClinicalTrials.gov NCT04215809, the US trial registry maintained by the National Library of Medicine. NCT04215809 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.