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

NCT05107856 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-01-31

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

PRT1419

PRT1419 will be administered by intravenous infusion

DRUG

Azacitidine

Azacitidine will be administered by intravenous or subcutaneous

DRUG

Venetoclax

Venetoclax will be administered orally

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2024-01-19
Completion
2024-01-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05107856 on ClinicalTrials.gov