PRT1419 as Monotherapy or in Combination With Azacitidine or Venetoclax in R/R Myeloid or B-cell Malignancies

Part of paid clinical trials in Orange City, Florida.

Sponsor
Prelude Therapeutics
Study ID
NCT05107856
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • PRT1419 — DRUG
    PRT1419 will be administered by intravenous infusion
  • Azacitidine — DRUG
    Azacitidine will be administered by intravenous or subcutaneous
  • Venetoclax — DRUG
    Venetoclax will be administered orally

Study Details

This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia-1 (MCL-1) inhibitor, in participants with selected relapsed/refractory myeloid or B-cell malignancies. The purpose of this study is to evaluate the safety and tolerability of PRT1419 monotherapy and in combination with either azacitidine or venetoclax, describe any dose limiting toxicities (DLTs), define the dosing schedule, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Key Dates

Start date
Mar 22, 2022
Status verified
Jan 2024
Primary completion
Jan 19, 2024
Completion
Jan 19, 2024

Study Design

Enrollment
21 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PRT1419 Monotherapy
    PRT1419 will be administered by intravenous infusion once weekly on a 28-day treatment cycle at the dose level assigned.
  • Experimental: PRT1419/Azacitidine Combination
    PRT1419 will be administered by intravenous infusion once weekly on a 28-day treatment cycle at the dose level assigned and Azacitidine will be administered by intravenous or subcutaneous on Days 1 through 7 (or alternatively on Days 1 through 5, 8 and 9) of each 28-day treatment cycle.
  • Experimental: PRT1419/Venetoclax Combination
    PRT1419 will be administered by intravenous infusion once weekly on a 28-day treatment cycle at the dose level assigned and Venetoclax will be administered orally after either a 3-day or 5-week ramp-up period to reach 400 mg daily administration, prior to commencing PRT1419 administration.

Primary Outcome Measure

Dose limiting toxicities (DLT) of PRT1419 [ Time Frame: Baseline through Day 28 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Mid Florida Hematology and Oncology CenterOrange CityFlorida32763-
AdventHealth Bone and Marrow Transplant CenterOrlandoFlorida32804-
American Oncology Partners of Maryland, PABethesdaMaryland20817-
New Jersey Center for Cancer ResearchBrickNew Jersey08724-
Memorial Sloan Kettering Cancer Center - Main CampusNew YorkNew York10065-
North Shore Hematology Oncology Associates. DBA New York Cancer and Blood SpecialistsPort Jefferson StationNew York11776-
Gabrail Cancer Center ResearchCantonOhio44718-
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvania19107-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Orange City, FL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Mid Florida Hematology and Oncology Center· Orange City, FLAdventHealth Bone and Marrow Transplant Center· Orlando, FLAmerican Oncology Partners of Maryland, PA· Bethesda, MDNew Jersey Center for Cancer Research· Brick, NJMemorial Sloan Kettering Cancer Center - Main Campus· New York, NYNorth Shore Hematology Oncology Associates. DBA New York Cancer and Blood Specialists· Port Jefferson Station, NY

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