NCT05107856

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

Terminated Phase 1 Last updated 31 January 2024

What this trial tests

Phase 1 trial testing PRT1419 in Acute Myeloid Leukemia in 21 participants. Terminated before completion.

Timeline

22 March 2022

Primary endpoint
19 January 2024

19 January 2024

Quick facts

Lead sponsor	Prelude Therapeutics
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	22 March 2022
Primary completion	19 January 2024
Estimated completion	19 January 2024
Sites	9 locations across United States

Drugs / interventions tested

• PRT1419 — full drug profile →
• Azacitidine (azacitidine) — full drug profile →
• Venetoclax (venetoclax) — full drug profile →

Conditions studied

• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
• B-cell Non-Hodgkin Lymphoma — all drugs for B-cell Non-Hodgkin Lymphoma →
• Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →
• Chronic Myelomonocytic Leukemia — all drugs for Chronic Myelomonocytic Leukemia →

Sponsor

Prelude Therapeutics — full company profile →

Who can join

18 and older, any sex, with Acute Myeloid Leukemia or B-cell Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The BCL2 family: from apoptosis mechanisms to new advances in targeted therapy.
   Vogler M, Braun Y, Smith VM, Westhoff MA, et al · · 2025 · cited 104× · PMID 40113751 · DOI 10.1038/s41392-025-02176-0
2. Targeting MCL-1 protein to treat cancer: opportunities and challenges.
   Tantawy SI, Timofeeva N, Sarkar A, Gandhi V. · · 2023 · cited 55× · PMID 37601693 · DOI 10.3389/fonc.2023.1226289
3. Selective MCL-1 inhibitor ABBV-467 is efficacious in tumor models but is associated with cardiac troponin increases in patients.
   Yuda J, Will C, Phillips DC, Abraham L, et al · · 2023 · cited 53× · PMID 37880389 · DOI 10.1038/s43856-023-00380-z
4. Drug Resistance Mechanisms of Acute Myeloid Leukemia Stem Cells.
   Niu J, Peng D, Liu L. · · 2022 · cited 49× · PMID 35865470 · DOI 10.3389/fonc.2022.896426
5. Altered pathways and targeted therapy in double hit lymphoma.
   Zhuang Y, Che J, Wu M, Guo Y, et al · · 2022 · cited 26× · PMID 35303910 · DOI 10.1186/s13045-022-01249-9
6. Targeting Apoptosis in AML: Where Do We Stand?
   Krawiec K, Strzałka P, Czemerska M, Wiśnik A, et al · · 2022 · cited 14× · PMID 36291779 · DOI 10.3390/cancers14204995
7. Patent landscape of inhibitors and PROTACs of the anti-apoptotic BCL-2 family proteins.
   Pal P, Zhang P, Poddar SK, Zheng G. · · 2022 · cited 14× · PMID 35993382 · DOI 10.1080/13543776.2022.2116311
8. Advancing the standard: venetoclax combined with intensive induction and consolidation therapy for acute myeloid leukemia.
   Lachowiez CA, Atluri H, DiNardo CD. · · 2022 · cited 13× · PMID 35510212 · DOI 10.1177/20406207221093964