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

Part of paid clinical trials in Duarte, California.

Sponsor
Ascentage Pharma Group Inc.
Study ID
NCT04215809
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • CLL/SLL

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Lisaftoclax — DRUG
    Lisaftoclax investigation drug in ramp up dosing

Study Details

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

Key Dates

Start date
Mar 2, 2020
Status verified
Apr 2025
Primary completion
Oct 31, 2025
Completion
Jun 30, 2027

Study Design

Enrollment
144 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lisaftoclax 400mg
    Lisaftoclax 400mg ramp up
  • Experimental: Lisaftoclax 600mg
    Lisaftoclax 600mg ramp up
  • Experimental: Lisaftoclax 800mg
    Lisaftoclax 800mg ramp up
  • Experimental: Lisaftoclax 1000mg
    Lisaftoclax 1,000mg ramp up

Primary Outcome Measure

Primary Toxicity Endpoint: dose limiting toxicity (DLT) [ Time Frame: 42 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Tanya Siddiqu, MD
Mayo ClinicJacksonvilleFlorida32224
Asher Chanan Khan, MD
Dana Farber Cancer InstituteBostonMassachusetts02215
Matthew Davids, MD
Novant HealthCharlotteNorth Carolina28204
Alan Skarbnik, MD
Gabrail Cancer CenterCantonOhio44718
carrie smith
[email protected]
Cleveland ClinicClevelandOhio44195
Allison Winter, MD
Swedish HealthSeattleWashington98122
John Pagel, MD

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City of Hope· Duarte, CAMayo Clinic· Jacksonville, FLDana Farber Cancer Institute· Boston, MANovant Health· Charlotte, NCGabrail Cancer Center· Canton, OHCleveland Clinic· Cleveland, OH

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