A Study Evaluating APG-115 as a Single Agent or in Combination With APG-2575 in Subjects With R/R T-PLL and NHL

Part of paid clinical trials in Houston, Texas.

Sponsor
Ascentage Pharma Group Inc.
Study ID
NCT04496349
Phase
PHASE2
Status
Recruiting
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Conditions

  • Non-Hodgkins Lymphoma
  • T-Prolymphocytic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • APG-115 — DRUG
    QOD, 2 weeks on, 1 week off, in repeated 21-day cycles
  • APG-2575 — DRUG
    APG-2575 given orally each day in cycle, in repeated 21-day cycles

Study Details

The goal of this study is to evaluate the pharmacokinetics (PK), safety, and efficacy of APG-115 as a single agent or in combination with APG-2575 in patients with T-PLL and NHL.

Key Dates

Start date
Jul 12, 2021
Status verified
Nov 2025
Primary completion
May 31, 2026
Completion
May 31, 2027

Study Design

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

Arms

  • Experimental: APG-115 monotherapy part
    APG-115 will be given alone
  • Experimental: APG-115 + APG-2575 combination dose escalation part
    APG-115 is given in combination with APG-2575
  • Experimental: APG-115 + APG-2575 combination dose expansion part
    APG-115 is given in combination with APG-2575

Primary Outcome Measure

Maximum tolerated dose of APG-115 [ Time Frame: 21 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD AndersonHoustonTexas77030
Kelly Quagliato
[email protected]
713-614-2069
Tapan Kadia, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson· Houston, TX

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